Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K162481 |
Device Name |
RF1400 Active Compression Wrap |
Applicant |
RECOVERY FORCE LLC |
12175 VISIONARY WAY, SUITE 540 |
FISHERS,
IN
46038
|
|
Applicant Contact |
Jeff Schwegman |
Correspondent |
M.SQUARED ASSOCIATES |
575 8TH AVE |
NEW YORK,
NY
10018
|
|
Correspondent Contact |
Deborah Lavoie Grayeski |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 09/06/2016 |
Decision Date | 02/16/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|