versatone-xt

GUDID 16977159460065

Gymmax Technology (Shenzhen) Co., Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 16977159460065
• NIH Device Record Key: 814efc4b-1e2a-46f3-8646-2259237e1c56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: versatone-xt
• Version Model Number: GMX-006
• 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	16977159460065 [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-xt]

• 16977159460065: GMX-006
• 06977159460068: GMX-006