Sonicator 718
Sonicator 718, 1 MHz, 5.5 cm2, portable ultrasound
4manufacturers in China registered for this device type
1catalogue number
7510(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 | Mettler Electronics 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 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K112520 |
| Record published | 2016-09-15 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 167 °F; Special storage condition: Operating Temperture: 50-104 F |
| Sizes | Weight 202 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ME 718 | Weight 202 g | In distribution |
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 |
| 50 Plus 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 |
Showing 12 of 44. All products under Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K053546 | 2006-05-04 |
| K013192 | 2001-10-17 |
| K883228 | 1988-08-18 |
| K880901 | 1988-03-17 |
| K880602 | 1988-02-25 |
| K873812 | 1987-12-10 |
| K851397 | 1985-07-02 |
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.