FES CYCLE ERGOMETER, MODEL RT300-S


Device Classification Name

stimulator, neuromuscular, external functional

510(k) Number K050036
Device Name FES CYCLE ERGOMETER, MODEL RT300-S
Applicant
RESTORATIVE THERAPIES INC.
2363 boston st.
baltimore, 
MD 
21224

Applicant Contact andrew barriskill
Correspondent
RESTORATIVE THERAPIES INC.
2363 boston st.
baltimore, 
MD 
21224

Correspodent Contact andrew barriskill
Regulation Number 882.5810
Classification Product Code
GZI  
Date Received 01/07/2005
Decision Date 06/27/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No