Device Classification Name |
powered exoskeleton
|
510(k) Number |
K183152 |
Device Name |
Phoenix |
Applicant |
US Bionics, Inc. (DBA suitX) |
4512 Hollis Street |
Emeryville,
CA
94608
|
|
Applicant Contact |
Kelly Mettler |
Correspondent |
AcKnowledge Regulatory Strategies, LLC |
2251 San Diego Avenue, Suite B-257 |
San Diego,
CA
92110
|
|
Correspondent Contact |
Allison C. Komiyama |
Regulation Number | 890.3480
|
Classification Product Code |
|
Date Received | 11/14/2018 |
Decision Date | 04/17/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT03175055
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|