Device Classification Name |
Wheelchair, Mechanical
|
510(k) Number |
K120628 |
Device Name |
HELIO |
Applicant |
MOTION COMPOSITES |
519 J-OSWALD-FOREST |
SUITE 101 |
SAINT-ROCH-DE-L' ACHIGAN,
CA
J063H0
|
|
Applicant Contact |
VINCENT LECUYER |
Correspondent |
MOTION COMPOSITES |
519 J-OSWALD-FOREST |
SUITE 101 |
SAINT-ROCH-DE-L' ACHIGAN,
CA
J063H0
|
|
Correspondent Contact |
VINCENT LECUYER |
Regulation Number | 890.3850
|
Classification Product Code |
|
Date Received | 03/01/2012 |
Decision Date | 12/19/2012 |
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
|
|
|