← Back to catalogue

Gem-Stim

FDA UDI

Class II (US FDA UDI)

by Gemore Technology Co., Ltd.

Identity

Trade Name
GEM-STIM FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
Digital EMS FDA UDI
Model / Reference
GM340E FDA UDI
Description
Digital EMS FDA UDI

Identifiers

Catalog Number
GM340E FDA UDI
Primary DI / UDI-DI
04712832960693 FDA UDI
FDA Product Code
IPF FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

Gem-Stim by Gemore Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Gemore Technology Co., Ltd.

Sources (1)

  • FDA UDI d0fab560-29aa-49c8-95d9-37e668870004 34 fields · synced May 30, 2026