Identity
- Trade Name
- Provant Infinity FDA UDI
- Generic Name
- Deep-tissue electromagnetic stimulation system, home-use FDA UDI
- Device Name
- The device includes a Control Unit and Treatment Applicator. The Control Unit is enclosed in a UL-compliant injection-molded case made of medical grade polycarbonate. The device also includes a Treatment Applicator and an external power supply that are attached to the Control Unit. When not in use, the device is stored inside the carrying case. The device may be removed from the carrying case prior to administration of therapy. Provant Infinity is indicated for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue. FDA UDI
- Model / Reference
- 4210 FDA UDI
- Description
- The device includes a Control Unit and Treatment Applicator. The Control Unit is enclosed in a UL-compliant injection-molded case made of medical grade polycarbonate. The device also includes a Treatment Applicator and an external power supply that are attached to the Control Unit. When not in use, the device is stored inside the carrying case. The device may be removed from the carrying case prior to administration of therapy. Provant Infinity is indicated for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868924000021 FDA UDI
- 510(k) Number
- K131979 FDA UDI
- FDA Product Code
- ILX FDA UDI
- GMDN Term
- Deep-tissue electromagnetic stimulation system, home-use 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
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
MR Unsafe FDA UDI
Provant Infinity by Regenesis Biomedical, Inc. — 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
- Regenesis Biomedical, Inc.
Sources (1)
- FDA UDI 2af93b37-2a81-4e78-9208-4fdb1bf7870e 37 fields · synced Jun 1, 2026