Identity
- Trade Name
- MyoVision SoloVision Hub FDA UDI
- Generic Name
- Multiple physiological signal amplifier FDA UDI
- Model / Reference
- D11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864021000339 FDA UDI
- 510(k) Number
- K123399 FDA UDI
- FDA Product Code
- KQX FDA UDIHCS FDA UDIHCC FDA UDIIKN FDA UDI
- GMDN Term
- Multiple physiological signal amplifier FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1500 FDA UDI882.1570 FDA UDI882.5050 FDA UDI890.1375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple physiological signal amplifier
MyoVision SoloVision Hub by Precision Biometrics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123399 also covers:
- DynaVision Belts — PRECISION BIOMETRICS INC
- DynaVision Dynamic sEMG Electrodes — PRECISION BIOMETRICS INC
- Dynamic Lead Wire Set — PRECISION BIOMETRICS INC
- Flexlite Charging Cable — PRECISION BIOMETRICS INC
- MyoPad Vault — PRECISION BIOMETRICS INC
- MyoVision DynaVision Dynamic sEMG — PRECISION BIOMETRICS INC
- MyoVision FlexVision Inclinometers — PRECISION BIOMETRICS INC
- MyoVision PhysioMonitor Hub — PRECISION BIOMETRICS INC
- MyoVision ScanVision Static sEMG Scanners — PRECISION BIOMETRICS INC
- MyoVision Software — PRECISION BIOMETRICS INC
- MyoVision Software — PRECISION BIOMETRICS INC
- MyoVision Software — PRECISION BIOMETRICS INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Precision Biometrics Inc
Sources (1)
- FDA UDI e75adcc3-6f92-4dda-995c-6e96d5df7214 33 fields · synced May 30, 2026