INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
FDA 510(k) clearance K040007 · decided 2004-07-07
Clearance details
- K-number
- K040007
- Device name
- INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
- Applicant
- Biomedical Life Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-02
- Decision date
- 2004-07-07
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- LIH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vecttor VT-300 (K231575) | Artaflex, Inc. | 2024-02-08 |
| ETD4000 (K202725) | Therasigma, LLC | 2021-03-26 |
| Avid IF2 (K183692) | Vision Quest Industries Inc./Dba VQ Orthocare | 2019-06-12 |
| GEMORE TRUE SINE INTERFERENTIAL STIMULATOR (K122944) | Gemore Technology Co, Ltd. | 2012-12-21 |
| VECTTOR VT-200 (K121662) | Alan Neuromedical Technologies, LLC | 2012-11-21 |
| EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 (K110509) | Everyway Medical Instruments Co.,Ltd | 2011-06-20 |
| MAX-IF1000 (K100246) | Bio Protech, Inc. | 2010-11-24 |
| INF 4160 PLUS, MODEL D-FJ31F (K092780) | Fuji Dynamics Limited | 2010-01-07 |
| IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D (K092763) | Well-Life Healthcare Limited | 2009-10-08 |
| IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E (K090023) | Well-Life Healthcare Limited | 2009-01-30 |
| EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 (K070890) | Everlife Medical Equipment Co., Ltd. | 2007-06-29 |
| IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2 (K060975) | Theratech, Inc. | 2006-05-10 |
Recalls involving this device
No recalls on record reference this clearance.