BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)


Device Classification Name

wheelchair, standup

510(k) Number K072475
Device Name BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)
Applicant
ETAC SVERIGE AB
1705 capital of texas highway
suite 500
austin, 
TX 
78746

Applicant Contact ian gordon
Correspondent
ETAC SVERIGE AB
1705 capital of texas highway
suite 500
austin, 
TX 
78746

Correspodent Contact ian gordon
Regulation Number 890.3900
Classification Product Code
IPL  
Date Received 09/04/2007
Decision Date 12/21/2007
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