Identity
- Trade Name
- GEM-STIM FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- OTC Combo TENS+EMS FDA UDI
- Model / Reference
- GM511TE FDA UDI
- Description
- OTC Combo TENS+EMS FDA UDI
Identifiers
- Catalog Number
- GM511TE FDA UDI
- Primary DI / UDI-DI
- 04712832961539 FDA UDI
- 510(k) Number
- K190988 FDA UDI
- FDA Product Code
- GZJ FDA UDIIPF FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 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
Yes
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
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Cleared under the same submission
K190988 also covers:
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
- GEM-STIM — GEMORE TECHNOLOGY CO., LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gemore Technology Co., Ltd.
Sources (1)
- FDA UDI e83efd1e-0bc0-4fa5-83e8-fd24973eac19 35 fields · synced Jun 6, 2026