ZEWA, INC.

ZEWA, INC.

Address:12960 Commerce Lakes Drive,Fort Myers,FL,33913,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) (4) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (3) Electrode, Cutaneous (GXY) (2) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

Zewa - 00682891111104 Catalog Number :

Device Description : Infrared Thermometer

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Zewa - 00682891210043 Catalog Number :

Device Description : TENS Unit Analog

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Zewa - 00682891210050 Catalog Number :

Device Description : TENS Unit Digital

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Zewa - 00682891210074 Catalog Number :

Device Description : TENS Unit Analog

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Zewa - 00682891210104 Catalog Number :

Device Description : TENS Unit Combo

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Zewa - 00682891210173 Catalog Number :

Device Description : SpaBuddy Relax

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Zewa - 00682891210197 Catalog Number :

Device Description : SpaBuddy Sport

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Zewa - 00682891210227 Catalog Number :

Device Description : TENS Unit 21022

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Zewa - 00682891210487 Catalog Number :

Device Description : Electrodes 2"x2" (4pcs.)

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Zewa - 00682891210494 Catalog Number :

Device Description : Electrodes Deluxe 2"x2" (4pcs.)

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

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