BioStim INF
BioStim INF: 1 catalogue number listed by BioMedical Life Systems Inc., United States, under Interferential Current Therapy. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
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 | BioMedical Life Systems Inc., United States |
|---|---|
| FDA product code | LIH |
| Device type | Interferential Current Therapy |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K040824 |
| Record published | 2016-09-23 |
| Record revised | 2019-10-23 (version 5) |
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 48 |
| Sizes | Height 6 in; width 2 in; length 7 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| INF | Height 6 in | 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 |
|---|---|
| K040007 | 2004-07-07 |
| K040824 | 2004-04-29 |
| K925687 | 1993-03-29 |
| K921441 | 1992-05-08 |
| K905571 | 1991-05-08 |
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.