| Device Classification Name |
Exerciser, Powered
|
| 510(k) Number |
K914394 |
| Device Name |
BACK MASTER |
| Applicant |
| Progressive Electrical Therapeutics |
| R.R. 80 Box 750a |
|
Camdenton,
MO
65020
|
|
| Applicant Contact |
GARY HUDDLESTON |
| Correspondent |
| Progressive Electrical Therapeutics |
| R.R. 80 Box 750a |
|
Camdenton,
MO
65020
|
|
| Correspondent Contact |
GARY HUDDLESTON |
| Regulation Number | 890.5380 |
| Classification Product Code |
|
| Date Received | 10/01/1991 |
| Decision Date | 11/13/1991 |
| 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
|
|
|