Identity
- Trade Name
- Omron Focus TENS Knee, Replacement Pad FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Replacement Pad for Focus Knee TENS . The pad is a disposable, conductive adhesive interface and should only be used with the Focus Knee TENS devices. FDA UDI
- Model / Reference
- PMKNPAD FDA UDI
- Description
- Replacement Pad for Focus Knee TENS . The pad is a disposable, conductive adhesive interface and should only be used with the Focus Knee TENS devices. FDA UDI
Identifiers
- Catalog Number
- PMKNPAD FDA UDI
- Primary DI / UDI-DI
- 00073796631468 FDA UDI
- 510(k) Number
- K183215 FDA UDI
- FDA Product Code
- NUH FDA UDINYN FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
Omron Focus TENS Knee, Replacement Pad by Omron Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Omron Healthcare, Inc.
Sources (1)
- FDA UDI cd960748-16f4-45f2-80ba-a79e307ec411 37 fields · synced Jun 1, 2026