| Device Classification Name |
Stimulator, Neuromuscular, External Functional
|
| 510(k) Number |
K770725 |
| Device Name |
STIMULATOR, MUSCLE, MODEL 107 |
| Applicant |
| Jaytronics, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Jaytronics, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 882.5810 |
| Classification Product Code |
|
| Date Received | 04/19/1977 |
| Decision Date | 04/26/1977 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|