Identity
- Trade Name
- TENS*STIM 211 FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Stimulator, muscle, powered, for muscle conditioning FDA UDI
- Model / Reference
- ME 211 FDA UDI
- Description
- Stimulator, muscle, powered, for muscle conditioning FDA UDI
Identifiers
- Catalog Number
- ME 211 FDA UDI
- Primary DI / UDI-DI
- 00816864020142 FDA UDI
- 510(k) Number
- K141299 FDA UDI
- FDA Product Code
- NGX FDA UDINUH FDA UDINYN FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5890 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
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 74 Gram FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Tens*stim 211 by Mettler Electronics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141299 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
- Mettler Electronics Corp.
Sources (1)
- FDA UDI 2628461d-e970-4510-9472-d6331be5044a 38 fields · synced May 30, 2026