BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5


Device Classification Name

stimulator, muscle, powered, for muscle conditioning

510(k) Number K081026
Device Name BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
Applicant
SPORT-ELEC S.A.
144 research drive
hampton, 
VA 
23666

Applicant Contact sharon scannell
Correspondent
SPORT-ELEC S.A.
144 research drive
hampton, 
VA 
23666

Correspodent Contact sharon scannell
Regulation Number 890.5850
Classification Product Code
NGX  
Date Received 04/10/2008
Decision Date 11/05/2008
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