Atlas FDA

IQC

24 FDA 510(k) clearances · Product code

38 daysmedian time to decision
68 days90th percentile
24clearances measured

FDA profile

Official device name
Wheelchair, Special Grade
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3880
Medical specialty
Physical Medicine
Flags
Third-party review eligible
Adverse events (MAUDE)
2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Hippocampe Marathon and Trail (K251570)Vipamat Sarl2025-06-23
MECHANICAL WHEELCHAIR (K120302)Novaf Andalucia 2007, SL2012-07-06
RENEGADE WHEELCHAIR (K082857)Alpha One2009-01-06
HIPPOCAMPE WHEELCHAIR (K051709)Vipamat Technologie2005-08-15
CALIFORNIA COMFORT FOUR WHEEL (K895384)Jubilee Scooters, Inc.1989-09-18
PCI CUSTOM DESIGN SERIES (K861943)Poston & Cole Intl.1986-05-30
QUALINE WHEELCHAIR PRODUCTS (K843213)Contemporary Health Sys1984-08-24
STANDARD WHEELCHAIR (K842719)Greene International Corp.1984-07-25
POIRIER VARIABLE WHEELCHAIR (K840234)Poirier S.A.1984-02-27
AMPUTEE WHEELCHAIR (K840627)Poirier S.A.1984-02-27
ARNAS WHEELCHAIR (K840631)Poirier S.A.1984-02-27
UNION WHEELCHAIR (K840625)Poirier S.A.1984-02-27
HEMIPLEGIC WHEELCHAIR (K840632)Poirier S.A.1984-02-27
POIRIER REGLADE WHEELCHAIR (K840630)Poirier S.A.1984-02-27
TRAINING WHEELCHAIR (K840635)Poirier S.A.1984-02-27
OLYMPIC & BASKET WHEELCHAIRS (K840634)Poirier S.A.1984-02-27
LARGE FRONT WHEELS WHEELCHAIR (K840628)Poirier S.A.1984-02-27
CHILDREN'S WHEELCHAIRS (K840636)Poirier S.A.1984-02-27
TRAIL CHAIR (K834498)Winchester Industries, Inc.1984-01-30
BASE ONLY, TORONTO CHAIR (K832322)Intl. Medical Equipment Corp.1983-08-12
FREEDOM 19 RECREATIONAL WHEELCHAIR (K831510)Carbonite Corp.1983-07-19
QUADRA WHEELCHAIR, QUADRA CHAIR, ETC. (K801317)Quadra Wheelchairs, Inc.1980-07-21
AVON TILTING PUSH CHAIR 14 (K770147)Maddak, Inc.1977-02-02
YORKHILL CHAIR (K770145)Maddak, Inc.1977-01-28

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Every clearance here is in the API, with alerts when new ones post.