Provant Therapy System
The device includes a Control Unit and Treatment Applicator. The Control Unit for the Provant Therapy System is housed in a UL-compliant injection-molded case made of high-impact ABS…
The device includes a Control Unit and Treatment Applicator. The Control Unit for the Provant Therapy System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy. The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue.
Who Else Makes It
Registered in Anhui.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| HI-DOW Electron Technology (Hefei) Inc., Ltd | Hefei | Anhui | Manufacturer | 5 |
Record
| Listed by | Regenesis Biomedical, Inc., United States |
|---|---|
| FDA product code | ILX |
| Device type | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5290 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-16 |
| Record revised | 2025-06-27 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature -40 to 158 °F |
| Distribution end date | 2024-04-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4201 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OrthoCor Medical | Caerus Corporation | 28 |
| TrueStim | HI-DOW International Inc. | 5 |
| ActiPatch | Bioelectronics Corporation | 1 |
| Provant Infinity | Regenesis Biomedical, Inc. | 1 |
| Disposable Applicator Cover | Regenesis Biomedical, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131979 | 2013-12-13 |
| K091791 | 2010-04-07 |
| K972093 | 1997-10-21 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-09-29 | Not classified | Finished device change control | In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio frequency energy. As such, for these few devices, the effect | 7 units | 2009-07-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.