Well Brain International Limited

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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

Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (3)

Premarket Exempt

Clear

Gymform Total ABS Platinum - 06973698290074 Catalog Number :

Device Description : An electrical powered muscle stimulation (EMS) unit, intended to use for perform An electrical powered muscle stimulation (EMS) unit, intended to use for performing non-destructive muscular conditioning to temporarily strengthen, tone or firm muscles in a complimentary way.

Device Class : 2

Duns Number: 663213551

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

Gymform Total ABS - 06973698290081 Catalog Number :

Device Class : 2

Duns Number: 663213551

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

Gymform Abs-A-Round - 06973698299824 Catalog Number : 644812017445

Device Description : The Gymform Abs-A-Round EMS Belt is FDA Class II 510k cleared intended to apply The Gymform Abs-A-Round EMS Belt is FDA Class II 510k cleared intended to apply electrical stimulation transcutaneously to tone, firm, and temporarily strengthen muscles through using the electric current pulse generator and the noninvasive electrodes. The EMS belt is a battery powered muscle stimulator, an over-the-counter device indicated for using to stimulate healthy muscles to facilitate and improve muscle performance in the intended areas on the body, a complimentary way to perform muscular training.

Device Class : 2

Duns Number: 663213551

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

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