Applicator 9401
940 applicator (Large size/ 1 & 3 MHz)
7manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (6), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
| Shenzhen Roundwhale Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Easymed Instruments Co., Ltd. | Daliang, Shunde, Foshan | Guangdong | Contract manufacturer | 8 |
| Fuji Dynamics Limited | Dongguan | Guangdong | Manufacturer | 6 |
| Xemis Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Mettler Electronics Corp., United States |
|---|---|
| FDA product code | LIH |
| Device type | Interferential Current Therapy |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K071137 |
| 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 |
|---|---|---|
| 9401 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GEM-Stim | Gemore Technology Co., Ltd. | 14 |
| Well-Life | Well-Life Healthcare Limited | 14 |
| Winner EVO Combo | Drive DeVilbiss Healthcare | 4 |
| Winner EVO Stim | Drive DeVilbiss Healthcare | 3 |
| High Voltage Galvanic Stimulator Kit | Control Solutions, Inc. | 2 |
| Chattanooga | DJO, LLC | 2 |
| Dynatron Solaris Plus 709 | Dynatronics Corp. | 2 |
| BodyMed | Boxout, LLC | 2 |
| CS6101 Interferential Kit | Control Solutions, Inc. | 2 |
| Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2 |
| CS6101-3-K01 Interferential Kit | Control Solutions, Inc. | 1 |
| Flex-TENS | Emsi | 1 |
Showing 12 of 58. All products under Interferential Current Therapy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K883080 | 1989-04-27 |
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.