Identity
- Trade Name
- Pointer Excel II FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- Pointer Excel II is the latest and most advanced user friendly stimulator. Features a built-in, 0.35" x 1.0" LCD digital meter which displays both frequency and location. Unit features two grounding plates on the unit (allowing use with either left or right hands) as well as a hand probe with grounding pole and attached wire. Two probe tips are included with unit: ear 2 mm (0.08") and body 4 mm (0.16"). Other standard accessories include 9 volt battery, carrying case, and instructions. FDA UDI
- Model / Reference
- ED3988 FDA UDI
- Description
- Pointer Excel II is the latest and most advanced user friendly stimulator. Features a built-in, 0.35" x 1.0" LCD digital meter which displays both frequency and location. Unit features two grounding plates on the unit (allowing use with either left or right hands) as well as a hand probe with grounding pole and attached wire. Two probe tips are included with unit: ear 2 mm (0.08") and body 4 mm (0.16"). Other standard accessories include 9 volt battery, carrying case, and instructions. FDA UDI
Identifiers
- Catalog Number
- ED3988 FDA UDI
- Primary DI / UDI-DI
- 14897076720054 FDA UDI
- 510(k) Number
- K060517 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 Excel II 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 029d0ad0-aff2-46df-94db-78d4622119f6 36 fields · synced May 30, 2026