REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM


Device Classification Name

wheelchair, mechanical

510(k) Number K111636
Device Name REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
Applicant
GUNNELL, INC.
8440 state
p.o. box 308
millington, 
MI 
48746

Applicant Contact andrew evancho
Correspondent
GUNNELL, INC.
8440 state
p.o. box 308
millington, 
MI 
48746

Correspodent Contact andrew evancho
Regulation Number 890.3850
Classification Product Code
IOR  
Date Received 06/13/2011
Decision Date 04/03/2012
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

Recalls CDRH Recalls