Identity
- Trade Name
- POLE ELECTRODE PEN TYPE FDA UDI
- Generic Name
- External manual massager, clinical FDA UDI
- Model / Reference
- PtP.Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14897076721143 FDA UDI
- FDA Product Code
- KNM FDA UDI
- GMDN Term
- External manual massager, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5765 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External manual massager, clinical
Pole Electrode Pen Type by Tens Plus Industrial Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External manual massager, clinical.
- NICE ICE — INTERNATIONAL SURGICAL PRODUCTS INC · Class I
- PAL650 Pressure feeler 650g — SEDATELEC · Class I
- PAL250 Pressure feeler 250g — SEDATELEC · Class I
- NICE ICE — INTERNATIONAL SURGICAL PRODUCTS INC · Class I
- PAL400 Pressure feeler 400g — SEDATELEC · Class I
- BAT02 Glass rods — SEDATELEC · Class I
- Rolyan — Performance Health Supply, LLC · Class I
- NICE ICE — INTERNATIONAL SURGICAL PRODUCTS INC · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tens Plus Industrial Company
Sources (1)
- FDA UDI 0fa7618c-3887-4f48-bb0e-d4cd9833131f 32 fields · synced May 30, 2026