Chattanooga
Direct Supply Panacea Shortwave Diathermy Device
1manufacturer
10catalogue numbers in this listing
1recall
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 | DJO, LLC, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-12 |
| Record revised | 2022-05-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 020453216 | In distribution | |
| 020453218 | In distribution | |
| 020453267 | In distribution | |
| 020453217 | In distribution | |
| 02200002 | In distribution | |
| 1601 | In distribution | |
| 020969553 | In distribution | |
| 1600 | In distribution | |
| 39-0700 | In distribution | |
| 020453266 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Megapulse II | Accelerated Care Plus Corp. | 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 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-08-21 | Class II | Device Design | Overheating and burning of the wire insulation inside the applicator. | 2887 | 2016-10-24 |
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.