BIOWAVE CORPORATION

BIOWAVE CORPORATION

Address:8 KNIGHT STREET,NORWALK,CT,06851,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

Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (5) Interferential Current Therapy (LIH) (3) Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief (NHI) (3)

Premarket Exempt

No

Clear

Biowave Percutaneous Electrodes - 00859911006003 Catalog Number :

Device Description : Biowave Percutaneous Electrode Set - B

Device Class : 2

Duns Number: 005759084

Premarket Exempt : No

Product Code : NHI

Prescription Use : Yes

Device Count : 1

BioWaveGO - 00859911006010 Catalog Number :

Device Description : BioWaveGO Neurostimulator

Device Class : 2

Duns Number: 005759084

Premarket Exempt : No

Product Code : GZJ

Prescription Use : No

Device Count : 1

Biowave Percutaneous Electrodes - 00859911006027 Catalog Number :

Device Description : Biowave Percutaneous Electrode Set - E

Device Class :

Duns Number: 005759084

Premarket Exempt : No

Product Code : NHI

Prescription Use : Yes

Device Count : 1

BiowavePRO - 00859911006065 Catalog Number :

Device Description : BiowavePRO Neurostimulator

Device Class : 2

Duns Number: 005759084

Premarket Exempt : No

Product Code : NHI

Prescription Use : Yes

Device Count : 1

BiowaveHOME - 00859911006072 Catalog Number :

Device Description : BiowaveHOME Neurostimulator

Device Class : 2

Duns Number: 005759084

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Biowave Noninvasive Electrodes - 00859911006089 Catalog Number :

Device Description : Biowave Noninvasive Electrode - B-Set

Device Class : 2

Duns Number: 005759084

Premarket Exempt : No

Product Code : GZJ, LIH

Prescription Use : Yes

Device Count : 1

Biowave Noninvasive Electrodes - 00859911006096 Catalog Number :

Device Description : Biowave Noninvasive Electrode - E-Set

Device Class : 2

Duns Number: 005759084

Premarket Exempt : No

Product Code : GZJ, LIH

Prescription Use : Yes

Device Count : 1

Biowave Noninvasive Electrodes - 00859911006102 Catalog Number :

Device Description : Biowave Noninvasive Electrode - U-Set

Device Class : 2

Duns Number: 005759084

Premarket Exempt : No

Product Code : GZJ, LIH

Prescription Use : Yes

Device Count : 1

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