Atlas FDA

KNO

35 FDA 510(k) clearances · Product code

17 daysmedian time to decision
47 days90th percentile
35clearances measured

FDA profile

Official device name
Accessories, Wheelchair
Device class
Class I (low risk)
Regulation
21 CFR 890.3910
Medical specialty
Physical Medicine
Flags
GMP exempt
Adverse events (MAUDE)
1997: 2 · 1998: 1 · 2000: 11 · 2006: 2 · 2007: 3 · 2013: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
REDMAN ACCESSORIES (K870298)Redman, Inc.1987-02-26
FRICTION FEEDER (K823646)Fred Sammons, Inc.1983-01-21
VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR (K823645)Fred Sammons, Inc.1983-01-21
WHEELCHAIR PATIENT RESTRAINTS (K823816)Danek Medical, Inc.1983-01-14
ARM THROUGH FOR WHEELCHAIR BK-6459-01 & (K823636)Fred Sammons, Inc.1982-12-28
CUSHIONS FOR WHEELCHAIR ARMS (K823635)Fred Sammons, Inc.1982-12-28
CLAMP ON HOLDER FOR A GLASS OR CUP (K823596)Fred Sammons, Inc.1982-12-22
HEAD SUPPORT FOR WHEELCHAIR (K823595)Fred Sammons, Inc.1982-12-22
WHEEL CHAIR ACCESSORIES (K821642)Fred Sammons, Inc.1982-06-11
WHEELCHAIR PAL (K820964)Pryor Products1982-04-16
BK-6453 RIMMED ACRYLIC LAP TRAY KIT (K813627)Fred Sammons, Inc.1982-01-19
WHEELCHAIR ACCESSORIES (K812350)Fred Sammons, Inc.1981-09-11
INCONTINENT PAD (K811482)Fred Sammons, Inc.1981-08-25
WHEELCHAIR RAMPS (K811486)Fred Sammons, Inc.1981-06-16
WHEELCHAIR ACCESSORIES (K811491)Fred Sammons, Inc.1981-06-12
WHEELCHAIR ACCESSORIES (K810448)Fred Sammons, Inc.1981-03-04
BODY STRAP (K810439)Fred Sammons, Inc.1981-03-04
BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF (K801709)Fred Sammons, Inc.1980-08-07
EZ ON SAFETY PONCHO (K801489)Skil-Care Corp.1980-07-14
HAMILTON TUCKAWAY DESK (K801214)Orthopedic Systems, Inc.1980-05-30
SKIL-CARE LEG PADS (K800208)Skil-Care Corp.1980-02-21
ADJUSTABLE HEIGHT DESK ARM LAP TRAY KIT (K790176)Fred Sammons, Inc.1979-02-08
ASHTRAY FOR WHEELCHAIR (K790177)Fred Sammons, Inc.1979-02-08
BAG, WALDER (K781195)Fred Sammons, Inc.1978-07-31
BAG, WHEELCHAIR (K781194)Fred Sammons, Inc.1978-07-31
VEST, SUPPORT, TRUNK (K781202)Fred Sammons, Inc.1978-07-31
TRAY, LAP, MOLDED (K781203)Fred Sammons, Inc.1978-07-31
WHEELCHAIR MUFF (K780195)Orthopedic Equipment Co., Inc.1978-03-09
STRAP, LEGREST (K780191)Orthopedic Equipment Co., Inc.1978-02-14
TOE LOOPS (K780194)Orthopedic Equipment Co., Inc.1978-02-14
HEEL LOOPS (K780193)Orthopedic Equipment Co., Inc.1978-02-14
CANE OR CRUTCH PARKER (3/4, 7/8, L) (K760290)Fred Sammons, Inc.1976-09-08
DESK, BEANBAG SHUFFLE, BK-6059 (K760292)Fred Sammons, Inc.1976-09-08
CARPET COVERS FOR FOOTRESTS, BK-6467 (K760295)Fred Sammons, Inc.1976-09-08
ADJUSTER, WHEELCHAIR WIDTH, BK-6470 (K760296)Fred Sammons, Inc.1976-09-08

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