Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Comfort Orthopedic Co., Ltd. — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

81 daysmedian FDA review time
209 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K102734COMFORT STANDING WHEELCHAIR, HERO SERIESComfort Orthopedic Co., Ltd.2010-12-14830
K072711COMFORT POWERED WHEELCHAIR, LY-EB 206Comfort Orthopedic Co., Ltd.2007-10-31360
K072712COMFORT ELECTRIC SCOOTER, LY-EW408Comfort Orthopedic Co., Ltd.2007-10-31360
K063030COMFORT SCOOTER MODEL LY-EW406Comfort Orthopedic Co., Ltd.2006-12-04620
K063032COMFORT SCOOTER, MODEL LY-EW415Comfort Orthopedic Co., Ltd.2006-10-16130
K031621HERO 1, MODEL LY-ESB220Comfort Orthopedic Co., Ltd.2004-01-222440
K031618COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2Comfort Orthopedic Co., Ltd.2003-12-182090
K030355COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202Comfort Orthopedic Co., Ltd.2003-05-201060
K030356COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103Comfort Orthopedic Co., Ltd.2003-05-201060
K023581COMFORT AGILE SCOOTER, LY-EW303Comfort Orthopedic Co., Ltd.2002-12-02390
K021910COMFORT DREAMRIDER SCOOTER, LY-EW402Comfort Orthopedic Co., Ltd.2002-10-111230
K022369COMFORT WINDJOY SCOOTER, MODEL LY-EW302Comfort Orthopedic Co., Ltd.2002-10-11810
K020451COMFORT WHEELCHAIRSComfort Orthopedic Co., Ltd.2002-03-14310

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda