Applicator 7001
706 applicator (10 cm sq.)
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) | K934846 |
| Record published | 2016-09-15 |
| Record revised | 2025-04-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: No; Storage environment temperature -40 to 167 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7001 | 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
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.