Atlas FDA

INN

26 FDA 510(k) clearances · Product code

25 daysmedian time to decision
185 days90th percentile
26clearances measured

FDA profile

Official device name
Chair, Adjustable, Mechanical
Device class
Class I (low risk)
Regulation
21 CFR 890.3100
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2021: 30 · 2022: 32 · 2023: 22 · 2024: 25 · 2025: 35 · 2026: 28
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
SPIFFY (K945650)Thames Valley Children'S Centre1994-12-19
THERADAPT HIGHCHAIR/STROLLER INSERT (K942397)Theradapt Products, Inc.1994-06-22
THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR (K930520)Theradapt Products, Inc.1993-03-24
ABLE GENERATION THERAPY TILT BENCH (K923753)The Able Generation, Inc.1993-01-29
ABLE GENERATION PLAY CHAIR (K923752)The Able Generation, Inc.1993-01-29
ABLE GENERATION BOOSTER CHAIR (K923750)The Able Generation, Inc.1993-01-29
KAYE MODEL KIAO PELVIC/THIGH STABILIZER (K923095)Kaye Products, Inc.1992-07-21
CHAIR, ADJUSTABLE, MECHANICAL (K922061)Kaye Products, Inc.1992-05-26
ACTIVITY CHAIR (K921272)Rifton Equipment For the Handicapped1992-04-07
BRODA NURSING CARE CHAIR (K904069)Broda Ent., Inc.1990-09-17
SHOWER-A-WAY (K902951)Tri-S-Sales and Mfg.1990-07-25
THE COMPANION NON-ELECTRIC LIFT CHAIR (K902600)Innovative Medical Engineering, Inc.1990-06-21
TOI-LIFT (K896814)Mill-Tech Ent., Inc.1990-02-20
CORNER SEAT (K894767)Canadian Posture and Seating Centre, Inc.1990-01-17
HIP SAVER (K882090)Pride Health Care, Inc.1988-05-26
CONVERTA-LITTER (K874060)Camtec1987-12-10
MERIVAARA GERIATRIC CHAIR MODEL 455 (K862957)Global Medical Prods, Inc.1986-08-21
CAR SEAT (K862885)Mednet, Inc.1986-08-14
ORTHOPEDIC SEATS (K862883)Mednet, Inc.1986-08-14
SPLIT SEAT POSITIONING CHAIR (K841691)Maddak, Inc.1984-05-09
RECLINING WHEELS (K832511)Reclining Wheels1983-08-31
THE PROGRESSIVE CHAIR (K823277)Progressive Productions , Ltd.1982-12-13
E-Z UP ARTHERAPEDIC CHAIR (K821651)Medical Device Consultants, Inc.1982-06-24
CHAIR, ADJUSTABLE, MECHANICAL (K812399)Kaye Products, Inc.1981-09-14
RAISED CHAIR W/FOOT PLATFORM (K812347)Fred Sammons, Inc.1981-09-11
SEATING STOOLS (K811484)Fred Sammons, Inc.1981-06-16

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