Device Classification Name |
Exerciser, Powered
|
510(k) Number |
K072887 |
Device Name |
G-TRAINER MEDICAL |
Applicant |
ALTER-G, INC. |
1090A O'BRIEN DRIVE |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
GLEN MANGSETH |
Correspondent |
ALTER-G, INC. |
1090A O'BRIEN DRIVE |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
GLEN MANGSETH |
Regulation Number | 890.5380
|
Classification Product Code |
|
Date Received | 10/10/2007 |
Decision Date | 01/25/2008 |
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
|
Recalls |
CDRH Recalls
|
|
|