Identity
- Trade Name
- Pointer-Plus FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- Pointer-Plus - Locator/Stim is a complete clinic in your hands. Modern, hand held, 6.5" long unit offers accurate acupuncture point stimulation with adjustable intensity dial. The pulse frequency is fixed at 10 Hz. The grounding circuit is made by holding the metal plate on the side of the unit or with the hand grounding pole. Accessories include 2 probe tips (ear 2 mm 0.08" and body 4 mm 0.16"), hand grounding pole with attached wire, 9 volt battery, carrying case, and instructions. FDA UDI
- Model / Reference
- ED3332 FDA UDI
- Description
- Pointer-Plus - Locator/Stim is a complete clinic in your hands. Modern, hand held, 6.5" long unit offers accurate acupuncture point stimulation with adjustable intensity dial. The pulse frequency is fixed at 10 Hz. The grounding circuit is made by holding the metal plate on the side of the unit or with the hand grounding pole. Accessories include 2 probe tips (ear 2 mm 0.08" and body 4 mm 0.16"), hand grounding pole with attached wire, 9 volt battery, carrying case, and instructions. FDA UDI
Identifiers
- Catalog Number
- ED3332 FDA UDI
- Primary DI / UDI-DI
- 14897076720047 FDA UDI
- 510(k) Number
- K060508 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
- 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
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
Pointer-Plus by Tens Plus Industrial Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Tens Plus Industrial Company
Sources (1)
- FDA UDI f081b155-88ae-4aa7-aa46-5bc2b57c7abb 36 fields · synced Jun 1, 2026