Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K102295 |
Device Name |
X2ABS DUAL CHANNEL FITNESS BELT |
Applicant |
LETO ENTERPRISES INCORPORATION |
19/F, NAN DAO COMMERCIAL BLDG, |
QUEENS ROAD CENTRAL |
HONG KONG,
CN
999077
|
|
Applicant Contact |
SABRINA WEI |
Correspondent |
LETO ENTERPRISES INCORPORATION |
19/F, NAN DAO COMMERCIAL BLDG, |
QUEENS ROAD CENTRAL |
HONG KONG,
CN
999077
|
|
Correspondent Contact |
SABRINA WEI |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 08/13/2010 |
Decision Date | 02/18/2011 |
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
|
|
|