Identity
- Trade Name
- ActiPatch FDA UDI
- Generic Name
- Hand-held deep-tissue electromagnetic stimulator FDA UDI
- Device Name
- ActiPatch Back Pain Relief Therapy 100 pack FDA UDI
- Model / Reference
- 088 FDA UDI
- Description
- ActiPatch Back Pain Relief Therapy 100 pack FDA UDI
Identifiers
- Catalog Number
- 090-4 FDA UDI
- Primary DI / UDI-DI
- 00851329005470 FDA UDI
- FDA Product Code
- PQY FDA UDI
- GMDN Term
- Hand-held deep-tissue electromagnetic stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5290 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ActiPatch by Bioelectronics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Bioelectronics Corporation
Sources (1)
- FDA UDI 4df545c0-a903-46b7-9a53-ee35e1f6c3e2 36 fields · synced May 30, 2026