BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
FDA 510(k) clearance K052625 · decided 2005-12-05
Clearance details
- K-number
- K052625
- Device name
- BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
- Applicant
- Bionicare Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-23
- Decision date
- 2005-12-05
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- NYN
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sparks, MD, 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 |
|---|---|---|
| BioniCare Hand System (K142236) | Vision Quest Industries, Inc. | 2015-03-23 |
| X-FORCE (K111557) | Seven Seas Distribtion and Manufacturing, LLC | 2011-11-10 |
| JOINT STIM, MODEL 1000 (K073386) | Pain Management Technologies | 2008-07-30 |
| RS-4I MUSCLE STIMULATOR FAMILY (K062325) | Rs Medical | 2007-04-13 |
| MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 (K030332) | Bionicare Medical Technologies, Inc. | 2003-06-06 |
| BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 (K983228) | Murray Electronics | 1999-03-15 |
| BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 (K971437) | Murray Electronics | 1997-07-22 |
Recalls involving this device
No recalls on record reference this clearance.