Atlas FDA

HME

16 FDA 510(k) clearances · Product code

38 daysmedian time to decision
161 days90th percentile
16clearances measured

FDA profile

Official device name
Chair, Ophthalmic, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.1140
Medical specialty
Ophthalmic
Adverse events (MAUDE)
1998: 1 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR (K930449)Marco Ophthalmic, Inc.1993-07-06
BREATH-EASY, MODIFICATION (K914416)Icor AB1992-06-23
RELIANCE(R) 6200 EXAMINATION CHAIR (K894018)Reliance Medical Products, Inc.1989-09-12
STORZ ENT/OPHTHALMIC MAXI CHAIR (K870112)Storz Instrument Co.1987-02-12
MODEL 6500 OPTHALMIC CHAIR (K864494)Koken Mfg Company, Inc.1986-12-15
MAC 150E OPTHALMIC CHAIR (K864574)Koken Mfg Company, Inc.1986-12-15
THE ERGOSYSTEM CHAIR (K863728)Charles D. Bell, Inc.1986-10-31
-OM WEST 2000 GNATUS CHAIR (K863008)Sds Dental, Inc.1986-09-24
TECHNA VISION, INC. ELECTRIC CHAIR (K853743)Techna Vision1985-10-17
RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 (K853149)F. & F. Koenigkramer1985-09-05
RELIANCE 6100 (K853150)F. & F. Koenigkramer1985-09-05
RELIANCE 5000 (K853151)F. & F. Koenigkramer1985-09-05
WOODLYN CLASSIC EXAM. CHAIR (K842045)Woodlyn, Inc.1984-06-19
DOWING OPHTHALMIC CHAIR AC-POWERED (K833539)Vision Health Technology1984-03-05
A O CUSTOM II CHAIR AND STAND (K801638)American Optical Corp.1980-08-13
MAXI-CHAIR (K781801)Surgical Mechanical Research, Inc.1978-11-03

Track HME automatically

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