PRECISION BIOMETRICS INC

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

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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

Yes No

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MyoPad Vault - 00853818007279 Catalog Number :

Device Description : MyoPad Vault (1), QuickScan Pads (2 jars), Low-profile tweezers (1)

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

Dynamic Lead Wire Set - 00853818007286 Catalog Number :

Device Description : 40" Dynamic Lead Wire Set (WireFree)

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

Power Supply for WireFree - 00853818007293 Catalog Number :

Device Description : Power Supply for WireFree System Hubs (WireFree)

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : IKN, HCC, HCS, KQX

Prescription Use : Yes

Device Count : 1

Myovision Charging Cable - 00853818007309 Catalog Number : PB-220

Device Description : PB-220 Myovision Charging Cable

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : IKN, HCC, HCS, KQX

Prescription Use : Yes

Device Count : 1

Flexlite Charging Cable - 00853818007316 Catalog Number : PB-225

Device Description : PB-225 Flexlite Charging Cable

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

USB 2.0 Cable (WireFree) - 00853818007323 Catalog Number : PB-202

Device Description : 3 ft. USB 2.0 cable for connecting a PhysioMonitor, SoloVision or VisionPort to a computer

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : Yes

Device Count : 1

USB Charger - 00853818007330 Catalog Number :

Device Description : USB Wall Charger

Device Class : 1

Duns Number: 362997926

Premarket Exempt : Yes

Product Code : KQX, HCS, HCC, IKN

Prescription Use : No

Device Count : 1

MyoVision Wirefree System - 00853818007347 Catalog Number : D11-D7L

Device Description : Solo Vision Hub with ScanVision Lite Static sEMG Scaner

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : No

Device Count : 1

MyoVision Wirefree System - 00853818007354 Catalog Number : D3-D5-D6-D7L

Device Description : PhysioMonitor Hub with FlexVision Inclinomters DynaVision Dynamic sEMG and ScanV PhysioMonitor Hub with FlexVision Inclinomters DynaVision Dynamic sEMG and ScanVision Lite Static sEMG Scanner

Device Class : 1

Duns Number: 362997926

Premarket Exempt : No

Product Code : KQX, HCS, HCC, IKN

Prescription Use : No

Device Count : 1

USB Charging Cable - 00853818007378 Catalog Number :

Device Description : USB Charging Cable for use with ScanVision, FlexVision, ThermoVision

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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