GYMFORM DUAL FLEX BELT MODEL WB-162


Device Classification Name

stimulator, muscle, powered, for muscle conditioning

510(k) Number K111781
Device Name GYMFORM DUAL FLEX BELT MODEL WB-162
Applicant
WELL BRAIN INTERNATIONAL, LTD.
100 granville road
tsim sha tsui east, kowloon
hong kong, sar china, 

CN

ch

Applicant Contact victor k wai
Correspondent
WELL BRAIN INTERNATIONAL, LTD.
100 granville road
tsim sha tsui east, kowloon
hong kong, sar china, 

CN

ch

Correspodent Contact victor k wai
Regulation Number 890.5850
Classification Product Code
NGX  
Subsequent Product Code
IRO  
Date Received 06/24/2011
Decision Date 07/11/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No