Device Classification Name |
Massager, Powered Inflatable Tube
|
510(k) Number |
K122154 |
Device Name |
POWERPLAY MUSCLE MASSAGER |
Applicant |
FIG, LLC |
2839 HARVEST MOON DRIVE |
ORANGE PARK,
FL
32073
|
|
Applicant Contact |
JOE ADKINS |
Correspondent |
FIG, LLC |
2839 HARVEST MOON DRIVE |
ORANGE PARK,
FL
32073
|
|
Correspondent Contact |
JOE ADKINS |
Regulation Number | 890.5650
|
Classification Product Code |
|
Date Received | 07/20/2012 |
Decision Date | 11/21/2012 |
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
|
|
|