Sonicator 740 Plus 5 Cm2 Applicator
Ultrasound and muscle stimulator plus 5 cm2 applicator
4manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
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 | Mettler Electronics Corp., 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, Manufacturer |
| 510(k) | K053546 |
| 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 | Special storage condition: No; Storage environment temperature -40 to 167 °F |
| Sizes | Weight 3.75 lb |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ME 740 | Weight 3.75 lb | 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 |
| 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 |
| OmniVersa | Accelerated Care Plus Corp. | 1 |
Showing 12 of 31. All products under Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111482 | 2011-08-25 |
| K071137 | 2007-08-01 |
| K943469 | 1994-08-29 |
| K934846 | 1994-03-23 |
| K934845 | 1994-01-21 |
| K921436 | 1993-04-27 |
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.