| Device Classification Name |
Exerciser, Powered
|
| 510(k) Number |
K862093 |
| Device Name |
GINGERBREAD MAN (TM) |
| Applicant |
| Southern Pride Manufacturing, Inc. |
| 1204 Sparta St. |
|
Mcminnville,
TN
37110
|
|
| Applicant Contact |
LEE TIETSWORTH |
| Correspondent |
| Southern Pride Manufacturing, Inc. |
| 1204 Sparta St. |
|
Mcminnville,
TN
37110
|
|
| Correspondent Contact |
LEE TIETSWORTH |
| Regulation Number | 890.5380 |
| Classification Product Code |
|
| Date Received | 06/02/1986 |
| Decision Date | 07/22/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|