Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K031611 |
Device Name |
P4-FITNESS |
Applicant |
VALMED CORP. |
5080 NORTH OCEAN DRIVE 1A |
SINGER ISLAND,
FL
33404
|
|
Applicant Contact |
GUY POITOUT |
Correspondent |
VALMED CORP. |
5080 NORTH OCEAN DRIVE 1A |
SINGER ISLAND,
FL
33404
|
|
Correspondent Contact |
GUY POITOUT |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 05/22/2003 |
Decision Date | 09/29/2004 |
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
|
|
|