Megapulse II
Shortwave Diathermy for use in applying therapeutic deep heat
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
Record
| Listed by | Accelerated Care Plus Corp., United States |
|---|---|
| FDA product code | IMJ |
| Device type | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5290 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-08-16 |
| Record revised | 2023-08-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-08-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1903029 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Chattanooga | DJO, LLC | 10 |
| ThermoPro | Zimmer Medizinsysteme Gmbh | 1 |
| Megapulse III/OmniSWD | Accelerated Care Plus Corp. | 1 |
| Richmar TheraTouch | Drive DeVilbiss Healthcare | 1 |
| Reprieve by Regenesis | Regenesis Biomedical, Inc. | 1 |
| Auto*Therm 390 | Mettler Electronics Corp. | 1 |
| Replexa+ Device | Promedtek, Inc. | 1 |
| Curapuls 670 | Enraf-Nonius B.V. | 1 |
| Replexa+ Treatment Applicator | Promedtek, Inc. | 1 |
| Drum Applicator 3980 | Mettler Electronics Corp. | 1 |
| BTL-703 | Btl Industries, Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153456 | 2016-06-14 |
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.