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

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06973698290081
• NIH Device Record Key: 02da20ff-8fb9-4cce-b093-c742987b44ba
• Commercial Distribution Discontinuation: 2023-04-25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gymform Total ABS
• Version Model Number: VDPGYCIND0132
• Company DUNS: 663213551
• Company Name: Well Brain International Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973698290081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202653

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-04
• Device Publish Date: 2021-04-26

Devices Manufactured by Well Brain International Limited

• 06973698290074 - Gymform Total ABS Platinum: 2021-05-14 An electrical powered muscle stimulation (EMS) unit, intended to use for performing non-destructive muscular conditioning to tem
• 06973698290081 - Gymform Total ABS: 2021-05-04An 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 ABS: 2021-05-04 An electrical powered muscle stimulation (EMS) unit, intended to use for performing non-destructive muscular conditioning to tem
• 06973698299824 - Gymform Abs-A-Round: 2020-11-10 The Gymform Abs-A-Round EMS Belt is FDA Class II 510k cleared intended to apply electrical stimulation transcutaneously to tone,