Atlas FDA

KNN

64 FDA 510(k) clearances · Product code

27 daysmedian time to decision
178 days90th percentile
64clearances measured

FDA profile

Official device name
Components, Wheelchair
Device class
Class I (low risk)
Regulation
21 CFR 890.3920
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2006: 8 · 2007: 3 · 2012: 28 · 2013: 77 · 2014: 64 · 2021: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (K211919)Kinetic Innovative Seating System, LLC2022-03-04
DYNASTY U1-31 (GELL/CELL) (K942309)Foley & Lardner1994-11-07
DYNASTY GC 12550 (GELL/CELL) (K942310)Foley & Lardner1994-11-07
DYNASTY GC 12400 (GELL/CELL) (K942308)Foley & Lardner1994-11-07
DYNASTY U1-33 AGM (K942311)Foley & Lardner1994-11-07
ALDEN WHEELCHAIR CUSHION (K942260)Ward and Assoc.1994-05-26
ALDEN LINEAGE WHEELCHAIR CUSHION (K942312)Lewis W. Ward1994-05-26
ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION (K933051)General Components Intl., Inc.1993-10-12
RHOMBO MEDICAL RHOMBO-FILL (K923942)International Medical Products, Inc.1993-03-24
PM (K925980)Pathfinder Intl. Corp.1993-03-24
TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST (K923364)Labac Systems, Inc.1993-03-22
VALU-PLUS PAD (K925336)Valmed, Inc.1993-02-12
TILT SEATING SYSTEM (K923366)Labac Systems, Inc.1993-02-12
NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC (K923186)Roho, Inc.1992-09-09
BIOMEDICAL HORIZONS MODEL 1001 (K921369)Biomedical Horizons, Inc.1992-05-11
MANUAL CHAIR BASE (K921027)Labac Systems, Inc.1992-03-20
CUSHION, WHELCHAR AND FLOTATION (K915629)Invacare Corp.1992-01-09
SERENA WHEELCHAIR CUSHIONS (K915368)A & C Medical Supply1991-12-20
PIN DOT ALUMINUM PAN (K913548)Pin Dot Products, Inc.1991-09-05
IMPALA AXLES (K913511)Pin Dot Products, Inc.1991-09-05
ARMREST (K913507)Pin Dot Products, Inc.1991-09-05
PIN DOT GROWTH/DIAL LINKS (K913553)Pin Dot Products, Inc.1991-09-05
PIN DOT TRUNION MOUNTS (K913550)Pin Dot Products, Inc.1991-09-05
PIN DOT MOUNTING BRACKETS (K913549)Pin Dot Products, Inc.1991-09-05
PIN DOT FLIP-DOWN ABDUCTOR (K913545)Pin Dot Products, Inc.1991-09-05
IMPALA CASTERS (K913546)Pin Dot Products, Inc.1991-09-05
IMPALA WHEELS (K913509)Pin Dot Products, Inc.1991-09-05
PIN DOT FOOTREST PRODUCTS (K913552)Pin Dot Products, Inc.1991-08-29
T.C.S. TOTAL CONTACT SEAT (K905013)Fundamental Products Co.1990-12-19
HANDI-TRAK WHEELCHAIR SNOW CHAINS (K904913)Handi-Trak, Inc.1990-11-07
THE CAROLINA ROCKER (K900839)Artec Environmental Monitoring Division1990-04-18
WHEELCHAIR STUMP SUPPORT (K890178)Gerber Chair Mates, Inc.1989-09-11
PERSONAL BACK WITH FIP KIT (K894770)Canadian Posture and Seating Centre, Inc.1989-09-11
E.Z. LOCK WHEELCHAIR RESTRAINT DEVICE (K894960)E.Z. Lock, Inc.1989-09-05
SLIDING ARM SUPPORT (K885105)Rolcontrol Products, Co., Inc.1988-12-27
LAYDOWN ARM SUPPORT MECHANISM (K885104)Rolcontrol Products, Co., Inc.1988-12-27
REMOVABLE BATTERY POWER SYSTEM (K885106)Rolcontrol Products, Co., Inc.1988-12-27
GILLUM'S WHEELCHAIR WIDTH REDUCING ATTACHMENT (K884052)Professional Service Unltd.1988-10-26
WHEELS-OFF QUICK RELEASE AXLE SYSTEM (K883679)Rolcontrol Products, Co., Inc.1988-09-13
STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT (K882253)Stoute'S "Assist-Seat" Corp.1988-06-27
LIFESTYLE SOF. CARE GEL CHAIR CUSHION (K882012)Gaymar Industries, Inc.1988-05-23
VAN-TEC PROSTATE BIOPSY NEEDLE (K870698)Van-Tec, Inc.1987-03-25
REDMAN UPHOLSTERY SERIES FOR WHEELCHAIRS (K870299)Redman, Inc.1987-02-10
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE (K863385)Cook Urological, Inc.1986-11-04
UPHOLSTERED BUCKET SEAT (K862887)Mednet, Inc.1986-08-14
SHS CUSHION/WHEELCHAIR (K861755)Special Health Systems, Ltd.1986-05-23
THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS (K861751)Special Health Systems, Ltd.1986-05-23
KINESETHETIC SEATING SYSTEM/WHEELCHAIR (K861754)Special Health Systems, Ltd.1986-05-23
BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID (K854710)Reloke Co.1986-04-16
COMFORTEX WHEELCHAIR CUSHION (K855181)Comfortex, Inc.1986-01-13
WHEELCHAIR ACCESSORIES (K840629)Poirier S.A.1984-02-27
ARM THROUGH FOR WHEELCHAIR BK 6454-01 & (K823638)Fred Sammons, Inc.1983-01-21
ARM THROUGH FOR WHEELCHAIR BK-6458-01 (K823637)Fred Sammons, Inc.1983-01-21
BERKELEY FORK (K823876)Berkeley Electric Wheelchair Co.1983-01-14
BERKELEY BRAKE (K823874)Berkeley Electric Wheelchair Co.1983-01-14
CHAIN KIT (K823875)Berkeley Electric Wheelchair Co.1983-01-14
CHAIN SILENCER (K823873)Berkeley Electric Wheelchair Co.1983-01-14
BERKELEY HARNESS (K823877)Berkeley Electric Wheelchair Co.1983-01-14
ELECATH PORTAL VEIN/BILIARY DRAIN ASSM (K821488)Electro-Catheter Corp.1982-05-28
PALM BEACH SEATING SYSTEM (K820761)Pb Sales C/O Geller & Bozeman1982-04-21
BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR (K813636)Fred Sammons, Inc.1982-01-19
DESK ARM WHEELCHAIR ARM EXTENSION (K812348)Fred Sammons, Inc.1981-09-11
LEGREST, ELEVATING (K780192)Orthopedic Equipment Co., Inc.1978-02-14
WHEELCHAIR SAFETY BELT (K771631)Medical Restraints, Inc.1977-09-12

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