Device Classification Name |
Exerciser, Non-Measuring
|
510(k) Number |
K120783 |
Device Name |
ABLE-X |
Applicant |
IM-ABLE LTD |
2400 VIA CARILLO |
PALOS VERDES ESTATES,
CA
90274
|
|
Applicant Contact |
SIGI CARON |
Correspondent |
IM-ABLE LTD |
2400 VIA CARILLO |
PALOS VERDES ESTATES,
CA
90274
|
|
Correspondent Contact |
SIGI CARON |
Regulation Number | 890.5370
|
Classification Product Code |
|
Date Received | 03/15/2012 |
Decision Date | 06/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|