Atlas FDA

IGLIDE MANUAL ASSIST WHEELCHAIR

FDA 510(k) clearance K030250 · decided 2003-03-04

Clearance details

K-number
K030250
Device name
IGLIDE MANUAL ASSIST WHEELCHAIR
Applicant
Independence Technology, LLC
Decision
Substantially Equivalent
Date received
2003-01-24
Decision date
2003-03-04
Days to decision
39 days
Clearance type
Traditional
Product code
ITI
Device class
2
Regulation number
890.3860
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Warren, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM (P020033/S002)Independence Technology, LLC2005-03-15
INDEPENDENCE IBOT 3000 MOBILITY SYSTEM (P020033/S001)Independence Technology, LLC2004-08-27
INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM (P020033)Independence Technology, LLC2003-08-13