ActiPatch
Back Pain Advanced long -Lasting Relief
1manufacturer
1catalogue number
1510(k) clearance
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 | Bioelectronics Corporation, 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, Complaint-file establishment, Manufacturer |
| Record published | 2015-07-22 |
| Record revised | 2026-03-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2035-07-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 088 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OrthoCor Medical | Caerus Corporation | 28 |
| TrueStim | HI-DOW International Inc. | 5 |
| Provant Infinity | Regenesis Biomedical, Inc. | 1 |
| Provant Therapy System | Regenesis Biomedical, Inc. | 1 |
| Disposable Applicator Cover | Regenesis Biomedical, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190251 | 2019-06-28 |
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.