Disposable Applicator Cover
Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological contamination. The cover is non-sterile and manufactured of…
Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological contamination. The cover is non-sterile and manufactured of polyethylene terephthalate (polyester) film and contains a Radio Frequency Identification Device (RFID) tag, which guards against reuse of used Disposable Applicator Covers.
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 | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2024-04-02 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PVTC30 | 30 | Withdrawn |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 |
| Provant Therapy System | 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.