RT300-S AND RT300-SP FES CYCLE ERGOMETER


Device Classification Name

stimulator, neuromuscular, external functional

510(k) Number K072398
Device Name RT300-S AND RT300-SP FES CYCLE ERGOMETER
Applicant
RESTORATIVE THERAPIES INC.
907 south lakewood ave.
baltimore, 
MD 
21224

Applicant Contact andrew barriskill
Correspondent
RESTORATIVE THERAPIES INC.
907 south lakewood ave.
baltimore, 
MD 
21224

Correspodent Contact andrew barriskill
Regulation Number 882.5810
Classification Product Code
GZI  
Date Received 08/27/2007
Decision Date 11/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No