versatone

GUDID 16977159460072

Gymmax Technology (Shenzhen) Co., Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 16977159460072
• NIH Device Record Key: 04459b68-5275-4f5c-b655-386f5d7136dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: versatone
• Version Model Number: GMX-007
• Company DUNS: 526849191
• Company Name: Gymmax Technology (Shenzhen) Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16977159460072 [Primary]

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2024-12-27
• Device Publish Date: 2024-12-19

On-Brand Devices [versatone]

• 16977159460096: GMX-KNEE01
• 16977159460072: GMX-007
• 06977159460099: GMX-KNEE01
• 06977159460075: GMX-007