PRECISION BIOMETRICS INC

Address:19109 36th Ave W,Lynnwood,WA,98036,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Biofeedback (HCC) (10) Device, Temperature Measurement, Direct Contact, Powered (HCS) (10) Electromyograph, Diagnostic (IKN) (10) Goniometer, Ac-Powered (KQX) (10)

Premarket Exempt

No Yes

Clear

MyoVision Wirefree System - 00853818007002 Catalog Number : D3-D5-D6

Device Description : PhysioMonitor Hub with Flexvision Inclinomters and DynaVision Dynamic sEMG

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

MyoVision Wirefree System - 00853818007019 Catalog Number : D3-D5-D6-D7

Device Description : PhysioMonitor Hub with Flexvision Inclinomters DynaVision Dynamic sEMG and ScanV

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

MyoVision Wirefree System - 00853818007026 Catalog Number : D3-D5-D7

Device Description : PhysioMonitor Hub with Flexvision Inclinomters and ScanVision Static sEMG Scaners

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

MyoVision Wirefree System - 00853818007033 Catalog Number : D3-D5FL-D7

Device Description : PhysioMonitor Hub with FlexVision FlexLite Inclinomters and ScanVision Static sEMG Scaners

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

MyoVision Wirefree System - 00853818007040 Catalog Number : D3-D6-D7

Device Description : PhysioMonitor Hub with DynaVision Dynamic sEMG and ScanVision Static sEMG Scaners

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

MyoVision Software - 00853818007057 Catalog Number :

Device Description : Software

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

MyoVision Software - 00853818007064 Catalog Number :

Device Description : Software

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : IKN, HCC, HCS, KQX

Prescription Use : Yes

Device Count : 1

MyoVision Software - 00853818007071 Catalog Number :

Device Description : Software

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

MyoVision Software - 00853818007088 Catalog Number :

Device Description : Software

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : IKN, HCC, HCS, KQX

Prescription Use : Yes

Device Count : 1

MyoVision Software - 00853818007095 Catalog Number :

Device Description : Software

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

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