Sonopuls 190
Sonopuls 190 delivers therapeutic ultrasound for pain relief, muscle spasm reduction and a local increase in blood flow. It also supports increasing movement of contracted joints when used…
Sonopuls 190 delivers therapeutic ultrasound for pain relief, muscle spasm reduction and a local increase in blood flow. It also supports increasing movement of contracted joints when used with heat and stretching techniques. The prescription equipment is intended for use by physicians.
The applicators generate ultrasound using piezoelectric crystals and operate at one or three megahertz. Continuous or pulsed delivery can be selected. Large and small applicators are available according to the treatment area, and both are suitable for treatment under water.
Listed Item
Device for ultrasound therapy
Contact Control
The device suspends ultrasound delivery when acoustic contact with the treatment area becomes insufficient. Two applicators can be connected, with activation selected through the ultrasound menu.
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 | Enraf-Nonius B.V., Netherlands |
|---|---|
| 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 | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K230472 |
| Record published | 2025-02-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 80 to 106 KiloPascal; Handling environment humidity 10 to 90 % RH; Handling environment temperature 10 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment temperature -20 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1631940 | In distribution | |
| 1631951 | 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 |
|---|---|
| K230472 | 2023-10-24 |
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.