RTM AND OVAL


Device Classification Name

wheelchair, mechanical

510(k) Number K080880
Device Name RTM AND OVAL
Applicant
NEXT MOBILITY, LLC
543 long hill avenue
shelton, 
CT 
06484

Applicant Contact joseph azary
Regulation Number 890.3850
Classification Product Code
IOR  
Date Received 03/31/2008
Decision Date 04/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No