Gymform Total ABS

GUDID 06973698290081

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.

Well Brain International Limited

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Primary Device ID06973698290081
NIH Device Record Key02da20ff-8fb9-4cce-b093-c742987b44ba
Commercial Distribution Discontinuation2023-04-25
Commercial Distribution StatusIn Commercial Distribution
Brand NameGymform Total ABS
Version Model NumberVDPGYCIND0132
Company DUNS663213551
Company NameWell Brain International Limited
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106973698290081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGXStimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

Devices Manufactured by Well Brain International Limited

06973698290074 - Gymform Total ABS Platinum2021-05-14 An electrical powered muscle stimulation (EMS) unit, intended to use for performing non-destructive muscular conditioning to tem
06973698290081 - Gymform Total ABS2021-05-04An 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.
06973698290081 - Gymform Total ABS2021-05-04 An electrical powered muscle stimulation (EMS) unit, intended to use for performing non-destructive muscular conditioning to tem
06973698299824 - Gymform Abs-A-Round2020-11-10 The Gymform Abs-A-Round EMS Belt is FDA Class II 510k cleared intended to apply electrical stimulation transcutaneously to tone,

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