Gymform Abs-A-Round 644812017445

GUDID 06973698299824

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.

Well Brain International Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06973698299824
• NIH Device Record Key: 9aaac11f-0c3d-4666-96d5-9cd2f385c8b8
• Commercial Distribution Discontinuation: 2022-08-13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gymform Abs-A-Round
• Version Model Number: VDP0016
• Catalog Number: 644812017445
• 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	06973698299824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130074

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: 2020-11-10
• Device Publish Date: 2020-11-02

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: 2021-05-04 An electrical powered muscle stimulation (EMS) unit, intended to use for performing non-destructive muscular conditioning to tem
• 06973698299824 - Gymform Abs-A-Round: 2020-11-10The 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.
• 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,