TrueStim
Pulsed Electromagnetic Field Wrap, Black, lower limb wrap
1manufacturer
5catalogue numbers in this listing
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 | HI-DOW International 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 | Complaint-file establishment |
| 510(k) | K202337 |
| Record published | 2021-01-04 |
| Record revised | 2023-09-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HD-08C(TSG-C1) | In distribution | |
| HD-08D(TSG-D1) | In distribution | |
| HD-08B(TSG-E1) | In distribution | |
| HD-08A(TSG-A1) | In distribution | |
| HD-08B(TSG-B1) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OrthoCor Medical | Caerus Corporation | 28 |
| ActiPatch | Bioelectronics Corporation | 1 |
| 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 |
|---|---|
| K202337 | 2020-12-15 |
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.