Device Classification Name |
exerciser, measuring
|
510(k) Number |
K926279 |
Device Name |
UPPER BODY EXERCISER |
Applicant |
HENLEY INTL. |
104 INDUSTRIAL BLVD., |
SUGAR LAND,
TX
77470
|
|
Applicant Contact |
ERNEST J HENLEY |
Correspondent |
HENLEY INTL. |
104 INDUSTRIAL BLVD., |
SUGAR LAND,
TX
77470
|
|
Correspondent Contact |
ERNEST J HENLEY |
Regulation Number | 890.5360
|
Classification Product Code |
|
Date Received | 12/14/1992 |
Decision Date | 05/05/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|