UltraTENSII
UltraTENS II - Ultrasound and
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Syntech Laser Co., Ltd. | Beijing | Beijing | Contract manufacturer | 5 |
| Ebulent Optronics (Shenzhen) Ltd | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Xemis Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Drive DeVilbiss Healthcare, United States |
|---|---|
| FDA product code | IMG |
| Device type | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5860 |
| Establishment | Repacker / relabeller |
| Record published | 2016-10-13 |
| Record revised | 2026-06-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | serial number |
| Packaging | Case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DU6012 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Chattanooga | DJO, LLC | 38 |
| Roscoe Medical | Drive DeVilbiss Healthcare | 7 |
| Johari Digital Healthcare Limited | Syrma Johari MedTech Limited | 4 |
| Johari Digital Healthcare Ltd. | Syrma Johari MedTech Limited | 2 |
| Sonicator Plus 940, 4 channel | Mettler Electronics Corp. | 1 |
| Applicator 7335 | Mettler Electronics Corp. | 1 |
| Sonicator 740 plus 5 cm2 applicator | Mettler Electronics Corp. | 1 |
| LG Med Supply | Drive DeVilbiss Healthcare | 1 |
| Omnisound 3000E | Accelerated Care Plus Corp. | 1 |
| Theratouch | Drive DeVilbiss Healthcare | 1 |
| Applicator 7305 | Mettler Electronics Corp. | 1 |
| Winner EVO Combo | Drive DeVilbiss Healthcare | 1 |
Showing 12 of 31. All products under Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
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.