Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K160323 |
Device Name |
FlowKeepers |
Applicant |
DK ELECTRONICS, LLC |
413-B ELMWOOD AVE, |
SHARON HILL,
PA
19079
|
|
Applicant Contact |
AVERY HUFF |
Correspondent |
DK ELECTRONICS, LLC |
413-B ELMWOOD AVE, |
SHARON HILL,
PA
19079
|
|
Correspondent Contact |
AVERY HUFF |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/05/2016 |
Decision Date | 04/06/2017 |
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
|
|
|