Everything our engineering, sourcing, and compliance work produced for this product. Nothing here is marketing — it's the actual document we'd hand a contract manufacturer.
Product family: WanderTricorder — the WanderVerse handheld clinical-assist tool Device IDs: WV-MED-TRICORDER-SCOUT · WV-MED-TRICORDER-CLINICAL · WV-MED-TRICORDER-RESEARCH Chassis: new — Handheld-Compact (130×65×28 mm) · Handheld-Standard (160×80×32 mm) · Handheld-Pro (180×90×36 mm) Status: spec v1.0-candidate — post-validation (Perplexity competitive + local-LLM clinical + sensor-tech audit + dual-mode principle applied), SOP v2.4 native, platform + modules, identity-aware, regulatory-honest Source input: Blueprint.am ref build medical_tricorder_tr_mx12 (treated as evidence, not design) Ship target: Scout 2028-Q1 · Clinical wellness 2028-Q4 · Research 2029-Q1 · FDA-cleared diagnostic claims rolling 2029-Q2 through 2030-Q3 Date: 2026-04-24
Shared family docs: ../_WORKFLOW-SOP.md · ../_HARDWARE-TOOLCHAIN.md · ../_FAMILY-EXPANSION-REVIEW.md · ../_STANDALONE-AND-PLATFORM-INTEGRATION.md · _VALIDATION-AND-SENSOR-EXPANSION.md · _COMPETITIVE-AUDIT-2026-04-24.md.
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WanderTricorder is not a wrist wearable. It's a handheld, episodic, on-demand panel-scan tool — a physical object you pick up, apply, read. It complements WanderBand (continuous passive wrist monitoring) rather than competing with it.
| Axis | WanderBand | WanderTricorder |
|---|---|---|
| Modality | continuous wrist PPG + baseline metrics | episodic clinical panel scan |
| Form | wrist wearable | handheld + detachable scanner puck |
| Price | $129-749 | $449-2,899 |
| FDA tier at launch | wellness | wellness (Scout) / phased clearances (Clinical/Research) |
| Ambassador tier | Tier 2 (wearable) | **Tier 3 (medical device)** — ISO 13485 trained |
| Regulatory weight | FCC + CE only (v1.0) | FCC + CE + IEC 60601-1 + 60601-1-2 + IEC 62304 + ISO 13485 + ISO 14971 |
Companion products, not alternatives. WanderBand streams continuous baseline → WanderTricorder provides the episodic deeper scan when band flags anomaly (or when the user just wants a panel check).
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WanderTricorder is a privacy-first, repair-friendly, identity-aware handheld clinical-assist tool that does things no handheld medical device on the market does — and does the standard clinical modalities without sending your data to a vendor cloud.
Three tiers serving three buyers:
| Tier | Price | Who | Killer feature |
|---|---|---|---|
| **Scout** | $449-579 | Household / home-medkit / travel health | 5-modality wellness panel (SpO2 + HR + temp + ECG + BIA) + Invisible Mode + no cloud ever |
| **Clinical** | $1,249-1,499 | Chronic-condition self-manager / caregiver / queer-affirming clinician | 11-modality clinical panel + **FDA-clearance pathway** for ECG/AFib/SpO2/cuffless-BP + privacy + HL7-FHIR + MyChart export |
| **Research** | $2,499-2,899+ | Research clinician / field medicine / queer-affirming provider / harm-reduction team | 14+ modalities including spectrometry + ultrasonic engineering-preview + ionization environmental monitor + UV-C sterilization |
All three tiers ship with:
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1. Households managing chronic conditions — cardiac (AFib, hypertension), respiratory (asthma, sleep apnea), metabolic (pre-diabetes, PCOS), inflammatory (autoimmune flares). The one device that gives you a full panel without sending the data to anyone. 2. Queer-affirming clinicians + trans-affirming providers — Fenway, Howard Brown, Callen-Lorde, Mazzoni, Plume, Included Health, FOLX. A device calibrated for non-cis bodies that respects patient agency. 3. Survivors of intimate partner violence / trafficking / abusive households — Invisible Mode lets you get clinical panels without leaving a digital trace. Clinical findings never leave your device. 4. Undocumented people — clinical scan without insurance, without surveillance, without ICE-accessible records. 5. Digital nomads / mobile-living / LGBTQ+ travelers — clinical panel travel-kit replacing an ER visit for minor travel-health events; works without WiFi; export via encrypted-ZIP to any clinician. 6. Harm-reduction programs — field-based health screening + overdose prevention + wound monitoring for unhoused + drug-using populations. Local-only, no data-linkage risk. 7. Field-medicine practitioners — Research tier for expedition medicine, remote-clinic augmentation, emergency-response. 8. Caregivers of elderly / disabled family — home-triage before hospital visit. 9. HRT users on self-managed regimens — baseline tracking, calibrated for your body, not a cis norm. 10. Home-birth + midwifery practices — wellness vitals panel for mother + infant (wellness-tier, not clinical-replacement).
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Zero competitors ship anything comparable.
Boot-time hardware-pin-read selects between 3 firmware partitions:
NVRAM flag is hardware-locked — cannot be changed by software alone, requires Ambassador-tier physical service (T5 Torx + specific sequence). Resists coercion ("unlock your phone" attacks don't work; there's nothing on the phone).
Ambassador configures Invisible Mode at order time. Tier 3 Medical Ambassador trained to explain the tradeoffs honestly: "Invisible Mode means no cloud backup, no phone sync, no emergency SOS — it's offline-clinical-instrument-only. Do you understand and accept this tradeoff?"
Use cases:
Mainstream medical devices are calibrated on cisgender baselines. WanderTricorder ships:
Mode 2 (industry integration) lets users hand findings to any clinician:
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Legend:
| Sensor | Part | Claim | FDA |
|---|---|---|---|
| Pulse oximetry + HR + HRV | MAX30102 | SpO2 + HR + HRV trend ⚠ | wellness only |
| Skin temperature (IR) | MLX90614 | temperature indicator ±0.5°C ⚠ | wellness only |
| Single-lead ECG | AD8232 | HR + rhythm indicator ⚠ | wellness only |
| Bio-impedance | AD5940 | body composition estimate (hand-to-hand) ⚠ | wellness only |
| Air quality | BME680 | VOC + humidity + pressure ⚠ | not applicable |
| Accelerometer (scanner) | LIS2DH (simpler) | orientation + scan-dwell detection | not applicable |
| ToF distance | VL53L1X | scan standoff gate | not applicable |
| Pulse-oximetry fingertip input | BLE-pair Nonin 3230 (optional) | external cleared pulse-ox input | inherits Nonin clearance |
Scout CANNOT unlock FDA-cleared ECG or SpO2 even via firmware — hardware is wellness-tier only. Buyers know upfront.
| Sensor | Part | Claim | FDA |
|---|---|---|---|
| Pulse oximetry multi-wavelength | **MAX86141** (upgrade) | SpO2 + HR + HRV + hydration ⚠/✓ v1.1 | wellness → 510(k) v1.1 |
| Single-lead ECG AFE | **MAX30003** (upgrade) | HR + rhythm + AFib indicator ⚠/✓ v1.1 | wellness → 510(k) v1.1 |
| Thermal array 32×24 | **MLX90640** | thermal imaging + inflammation observation ⚠ | wellness only v1.0 |
| Multispectral (11-ch) | **AS7341** | skin melanin + vascularity + light observation ⚠ | wellness only |
| UWB radar | **Qorvo DW3000** | respiration + HR via chest displacement (stationary) ⚠ | wellness only |
| Gas sensor (BME688) | **Bosch BME688** | gas-ML environmental + exhaled-VOC observation ⚠ | not applicable |
| Deep-vascular NIR | **AS7263** | NIR vascularity observation ⚠ | wellness only |
| Magnetometer | **Memsic MMC5983MA** | orientation + field orientation | not applicable |
| Ambient light + UV | **Vishay VEML6075** | circadian + skin-UV observation | not applicable |
| Altimeter + barometer | **Bosch BMP390** | altitude + altitude-medicine context | not applicable |
| Cellular LTE (option) | Telit FN990Axx | emergency SOS + HL7 FHIR remote sync | — |
Clinical's FDA roadmap:
All cleared claims unlock via firmware OTA — same hardware, new FDA-cleared feature flags.
| Sensor | Part | Claim | FDA |
|---|---|---|---|
| Micro-spectrometer | **Hamamatsu C12880MA** | molecular signature research 🔬 | research only; not a medical claim |
| Deep-tissue UWB radar | **Novelda Xethru X4** | deep-tissue research (plus DW3000) 🔬 | research only |
| MEMS gravimeter | **Murata SCA3300** | gait-loading + structural observation 🔬 | research only |
| PMUT ultrasonic | **TDK CH101** | ultrasonic ranging; NOT imaging 🔬 | research-engineering-preview only |
| UV-C sterilization | **LITE-ON LTPL-C034UVH275** | scanner-face sterilization (interlock-protected) | not a medical claim |
| Environmental ionization | **Pocket Geiger Type 5** | environmental hazard monitor (NOT medical dosimetry) | wellness-environmental only |
| Extended IMU (scanner 9-DOF) | **Bosch BNO055** | spatial tracking of scanner relative to patient | not applicable |
| Second display (hand-scanner) | 0.96″ OLED | scanner status indicator | not applicable |
| Dual wireless-charging (scanner + main) | Renesas P9235 + P9221 | hands-free charging | not applicable |
Research tier ships "non-diagnostic research tool" framing OR takes regulated-device path depending on claim.
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Works fully with ZERO other WanderVerse purchases. User buys, opens box, Ambassador card, pairs with their existing phone (iOS or Android companion app), runs clinical panel. All data local. Export via USB-C + encrypted ZIP. No other WanderVerse device required.
Mode 3 unlocks additional depth but is NOT required.
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| Tier + config | Retail | Notes |
|---|---|---|
| **Scout bare-minimum** | **$449** | SpO2 + HR + temp + ECG + BIA + IR thermometer |
| **Scout typical home medkit** | **$579** | above + multi-wavelength PPG + BME688 + thumb-ECG plate |
| **Clinical baseline (wellness at launch)** | **$1,249** | 11 modalities — all Scout + UWB radar + spectral + thermal array + NIR + gravimeter + more |
| **Clinical with 510(k)-cleared ECG + AFib** | **$1,499** | same HW, firmware unlock after clearance (2029-Q1+) |
| **Research field-medicine** | **$2,499** | 14+ modalities — all Clinical + micro-spectrometer + ionization + UV-C + PMUT + dual wireless-charging |
| **Research Ambassador Artisan** | **$2,899+** | hand-finished billet-aluminum + leather accessories + custom Ambassador engraving |
Gross margins (per validation audit): Scout 53% / Clinical 51% / Research 45%.
WanderAssist subscription (optional):
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Hardware-locked NVRAM flag. Set at Ambassador assembly time. Cannot be changed by software alone.
Firmware partition selection at boot:
Boot → Hardware pin read → Select partition:
[INVISIBLE_FLAG_SET] → Boot to Invisible partition
- All radios: hardware-power-off (transistor cut before SoC)
- All loggers: disabled at kernel
- All telemetry: blackholed
- Data: RAM-only, wipes on power-off
- Cloud: no connection possible
- Operates as: offline clinical instrument
[NORMAL_FLAG] → Boot to Normal partition
- Full features; user-configurable privacy per-session
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Scout launches as a wellness device. No FDA submissions required for wellness-tier claims. Marketing: "heart-rate indicator," "body-composition estimate," "temperature indicator," "single-lead ECG observation" — NO "diagnostic," "clearance," or "clinical-grade" claims.
Clinical launches as a wellness device with medical-device-hardware-safety certifications. IEC 60601-1 + 60601-1-2 + IEC 62304 + ISO 13485 + ISO 14971 compliance required because the hardware is marketed for patient contact, even though v1.0 claims are wellness only.
Research launches as "non-diagnostic research tool" with same hardware-safety cert as Clinical.
| Claim | Pathway | Submission | Target clearance | Firmware unlock |
|---|---|---|---|---|
| Single-lead ECG (rhythm observation) | 510(k), predicate KardiaMobile | 2028-Q1 | 2028-Q3 | v1.1 |
| AFib detection algorithm | 510(k), predicate Apple Watch / KardiaMobile | 2028-Q2 | 2029-Q1 | v1.1 |
| Clinical-grade SpO2 | 510(k), predicate Masimo/Nonin | 2028-Q4 | 2029-Q3 | v1.1.1 |
| Cuffless BP (PPG+PTT) | De Novo | 2029-Q1 | 2030-Q2 | v1.2 |
| Non-invasive glucose | separate novel-device pathway | TBD | 2030+ | v2.x |
| AI-interpretation features (ECG rhythm classification) | separate per-algorithm 510(k) | staged | 2029+ | v1.1+ |
Firmware architecture: each cleared claim is gated by a feature flag verified against FDA clearance letter hash. OTA update activates the flag only for devices in regions where the claim is cleared.
Pre-launch (v1.0 wellness):
Phased clearance (v1.1+):
Total over 36 months post-launch: $400-800k pre-launch + $1.0-1.5M phased clearances = $1.5-2.3M cumulative regulatory investment for full Clinical panel cleared.
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WanderTricorder is the first WanderVerse product requiring Tier 3 Medical Ambassador assembly.
Tier 3 qualifications:
Assembly times:
Ambassador pay scale Tier 3: higher than Tier 2 given additional certification burden. Target: $55/hr Ambassador-average on Tier 3 work (vs ~$40/hr Tier 2), enabling ~$85-130 per-unit labor depending on tier.
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Per WanderVerse standard, WanderTricorder revenue feeds the 60/30/10 Ambassador Program split:
Community Pool Layer 2 programs specifically funded by WanderTricorder revenue:
See ../WANDERVERSE-COMMUNITY-POOL-SPEC.md.
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| Tier | EVT | DVT | PVT | First ship | FDA claims |
|---|---|---|---|---|---|
| Scout | 2027-Q3 | 2027-Q4 | 2028-Q1 | **2028-Q1** | wellness only |
| Clinical | 2028-Q1 | 2028-Q3 | 2028-Q4 | **2028-Q4** | wellness → ECG+AFib 2029-Q1 → SpO2 2029-Q3 → BP 2030-Q2 |
| Research | 2028-Q3 | 2028-Q4 | 2029-Q1 | **2029-Q1** | non-diagnostic research framing |
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1. FDA pre-submission filed 2027-Q1 — the clock starts there, not at submission. 2. Academic clinical partner committed 2027-Q1 — for validation studies. 3. Tier 3 Medical Ambassador curriculum + first cohort 2027-Q2. 4. ISO 13485 CM selected 2027-Q2. 5. Engineering team hired 2026-Q4 start — EE + medical-FW + clinical-algorithms + industrial-design — can't slip. 6. Invisible Mode FW + HW spec locked at EVT gate — safety-critical. 7. Hamamatsu C12880MA FAE relationship 2027-Q1.
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WanderTricorder is the most ambitious WanderVerse hardware product yet and the first to require Tier 3 Medical Ambassador, ISO 13485 manufacturing, IEC 62304 medical software lifecycle, and phased FDA clearance.
What we truthfully promise: 1. Most clinical modalities in any handheld device on the market. 2. Privacy posture no medical device competitor matches. 3. Invisible Mode — category-defining safety feature. 4. Trans-affirming, identity-aware clinical calibration. 5. Framework-Laptop-level repairability + 7-year parts. 6. Ambassador-built with named-human provenance. 7. Staged FDA clearance for specific claims post-launch — wellness at launch, cleared claims layered in over 18-36 months. 8. Community Pool integration — buying this device funds queer-affirming clinical-research grants, harm-reduction device donations, and free-clinic unit donations.
What we don't overclaim: 1. Not a substitute for professional medical diagnosis. 2. Not hospital-ICU-grade. 3. Not best-in-class on any single modality (Butterfly wins ultrasound, KardiaMobile wins ECG cost, Masimo wins SpO2). 4. FDA clearance timing is honest — 18-36 months post-launch per claim. 5. Research tier sensors that are engineering-preview are clearly labeled as such.
For the right customer, this is the first clinical-assist tool that respects their agency, their privacy, their identity, their budget over time, and their right to understand and own the device.
"Not a watch. A clinical assist tool."