Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K122414 |
Device Name |
AB COMMAND DUAL CHANNEL FITNESS BELT |
Applicant |
LETO ENTERPRISES INCORPORATION |
SUITE A-2706, ZHONGFANG JINGYUAN |
XINWEN ROAD, FUTIAN DISTRICT |
SHENZHEN,
CN
518100
|
|
Applicant Contact |
SABRINA WEI |
Correspondent |
LETO ENTERPRISES INCORPORATION |
SUITE A-2706, ZHONGFANG JINGYUAN |
XINWEN ROAD, FUTIAN DISTRICT |
SHENZHEN,
CN
518100
|
|
Correspondent Contact |
SABRINA WEI |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 08/08/2012 |
Decision Date | 12/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|