GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
FDA 510(k) clearance K122944 · decided 2012-12-21
Clearance details
- K-number
- K122944
- Device name
- GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
- Applicant
- Gemore Technology Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-09-24
- Decision date
- 2012-12-21
- Days to decision
- 88 days
- Clearance type
- Special
- Product code
- LIH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Tan Shui, New Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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| 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 |
| DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE (K052289) | Biowave Corporation | 2005-12-13 |
Recalls involving this device
No recalls on record reference this clearance.