versatone - xt

GUDID 16977159460102

Gymmax Technology (Shenzhen) Co., Ltd.

Electrode/transducer strap, reusable
Primary Device ID16977159460102
NIH Device Record Key8dce7164-cb4f-4417-8b29-d934e26b0c92
Commercial Distribution StatusIn Commercial Distribution
Brand Nameversatone - xt
Version Model NumberGMX-WRIST01
Company DUNS526849191
Company NameGymmax Technology (Shenzhen) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS116977159460102 [Primary]

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-27
Device Publish Date2024-12-19

On-Brand Devices [versatone - xt]

16977159460102GMX-WRIST01
06977159460105GMX-WRIST01

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.