AccessGUDID - DEVICE: GEM-STIM (04712832961737)

GUDID

Device Identifier (DI) Information

Brand Name: GEM-STIM
Version or Model: GM310PE(OTC)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GM310PE(OTC)
Company Name: GEMORE TECHNOLOGY CO., LTD.

Primary DI Number: 04712832961737
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658435078 *Terms of Use

Device Description: OTC EMS (Muscle Conditioner)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35372	Analgesic transcutaneous electrical nerve stimulation system	An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102926	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fa2f02fc-1c72-4b66-8042-f9dab6d15366
Public Version Date: September 18, 2023
Public Version Number: 1
DI Record Publish Date: September 08, 2023