Identity
- Trade Name
- Tech-Med FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- GM3A50T(0) Analog TENS FDA UDI
- Model / Reference
- 6010 FDA UDI
- Description
- GM3A50T(0) Analog TENS FDA UDI
Identifiers
- Catalog Number
- 6010 FDA UDI
- Primary DI / UDI-DI
- 00665973016788 FDA UDI
- 510(k) Number
- K032720 FDA UDI
- FDA Product Code
- GZJ FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 45 Kilogram FDA UDI
Tech-Med by Dukal LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K032720 also covers:
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
- Dukal LLC
Sources (1)
- FDA UDI ea6490d6-ea0e-49c7-ae52-5e0722cfb6df 38 fields · synced May 30, 2026