MyoVision Software Feature Pack A
MyoVision Software Feature Pack A is a Class II device made by Precision Biometrics Inc, cleared under FDA 510(k) K123399 on 1 Aug 2013 and listed in FDA GUDID since 27 Nov 2016 (UDI-DI 00853818007064), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00853818007064 | Date27 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123399 | Date1 Aug 2013 | StatusActive |
Official records
- AccessGUDID record 00853818007064
- FDA 510(k) database K123399
Across registries
- FDA 510(k) K123399 decided 1 Aug 2013 Active
- FDA GUDID UDI-DI 00853818007064 listed 27 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K123399
- Listed FDA GUDID 00853818007064
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MyoVision Software
- Generic name
- Bioelectrical signal analysis software
- Model / reference
- Feature Pack A
- Primary DI / UDI-DI
- 00853818007064
- 510(k) Number
- FDA product code
- IKN, HCC, HCS, KQX
- GMDN term
- Bioelectrical signal analysis software
- Device class
- Class II
- Regulation number
- 890.1375, 882.5050, 882.1570, 888.1500
- GUDID distribution status
- In Commercial Distribution
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