ELECTRONIC WAVEFORM LAB, INC

Address:5702 Bolsa Ave,Huntingtn Bch,CA,92649,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

Electrode, Cutaneous (GXY) (1) Stimulator, Muscle, Powered (IPF) (1) Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (1) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (1)

Premarket Exempt

Clear

H-Wave - 00869844000207 Catalog Number :

Device Description : Powered Muscle Stimulator

Device Class : 2

Duns Number: 065105561

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

H-Wave EWL - 00869844000214 Catalog Number :

Device Description : Electrode, Cutaneous

Device Class : 2

Duns Number: 065105561

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

H-Wave - 00869844000221 Catalog Number :

Device Description : Powered Muscle Stimulator

Device Class : 2

Duns Number: 065105561

Premarket Exempt : No

Product Code : NGX, NUH

Prescription Use : No

Device Count : 1

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