SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515


Device Classification Name

stimulator, muscle, powered, for muscle conditioning

510(k) Number K030708
Device Name SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
Applicant
BIO-MEDICAL RESEARCH, LTD.
parkmore business park,
west galway, 

IE

Applicant Contact michelle sawyer
Correspondent
BIO-MEDICAL RESEARCH, LTD.
parkmore business park,
west galway, 

IE

Correspodent Contact michelle sawyer
Regulation Number 890.5850
Classification Product Code
NGX  
Date Received 03/06/2003
Decision Date 06/25/2003
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