50 Plus Soundhead
3 catalogue numbers from CM02SH, listed by Dynatronics Corp., United States, under Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Grandway Technology (Shenzhen) Limited | Shenzhen | Guangdong | Contract manufacturer | 6 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
Record
| Listed by | Dynatronics Corp., United States |
|---|---|
| FDA product code | IMI |
| Device type | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5300 |
| Record published | 2016-09-24 |
| Record revised | 2025-04-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C |
| Sizes | Area/surface area 2 to 10 Square centimeter |
| Distribution end date | 2023-10-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CM02SH | Area/Surface Area 2.0 Square centimeter | Withdrawn |
| CM10SH | Area/Surface Area 10.0 Square centimeter | Withdrawn |
| CM05SH | Area/Surface Area 5.0 Square centimeter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Chattanooga | DJO, LLC | 26 |
| Dynatron Soundhead ` | Dynatronics Corp. | 6 |
| Ultrasound Accessories | Drive DeVilbiss Healthcare | 4 |
| Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 4 |
| Solaris Soundhead | Dynatronics Corp. | 3 |
| Therasound EVO | Drive DeVilbiss Healthcare | 3 |
| Therasound | Drive DeVilbiss Healthcare | 2 |
| Echo Ultrasound Device (USA) | Thermotek, Inc. | 2 |
| Therasound Evo 120V | Drive DeVilbiss Healthcare | 2 |
| Echo Ultrasound Device (PRC) | Thermotek, Inc. | 2 |
| Therasound EVO Package | Drive DeVilbiss Healthcare | 2 |
| ManaMed Transducer Fixation Strap | Manamed LLC | 2 |
Showing 12 of 44. All products under Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K031329 | 2003-10-22 |
| K961250 | 1996-08-26 |
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.