SYSTEM-ARMS, MODEL 390,E60


Device Classification Name

stimulator, muscle, powered, for muscle conditioning

510(k) Number K072553
Device Name SYSTEM-ARMS, MODEL 390,E60
Applicant
BIO-MEDICAL RESEARCH, LTD.
parkmore business park west
galway, 

IE

Applicant Contact anne-marie keenan
Correspondent
BIO-MEDICAL RESEARCH, LTD.
parkmore business park west
galway, 

IE

Correspodent Contact anne-marie keenan
Regulation Number 890.5850
Classification Product Code
NGX  
Date Received 09/10/2007
Decision Date 12/14/2007
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