Gymform Total ABS Platinum

GUDID 06973698290074

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 Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06973698290074
• NIH Device Record Key: 40b1bdca-6015-4eb2-b55e-558645a916d1
• Commercial Distribution Discontinuation: 2025-06-05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gymform Total ABS Platinum
• Version Model Number: VDPGYCIND0131
• 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	06973698290074 [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: 2021-05-14
• Device Publish Date: 2021-05-06

Devices Manufactured by Well Brain International Limited

• 06973698290074 - Gymform Total ABS Platinum: 2021-05-14An 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.
• 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: 2020-11-10 The Gymform Abs-A-Round EMS Belt is FDA Class II 510k cleared intended to apply electrical stimulation transcutaneously to tone,