Atlas FDA

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

Imc-Heart Way LLC · Predicate Candidate Screening

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

96 daysmedian FDA review time
175 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K063328IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE Imc-Heart Way LLC2007-04-271750
K063320ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)Imc-Heart Way LLC2007-02-271170
K063307ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)Imc-Heart Way LLC2007-02-271180
K063203ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)Imc-Heart Way LLC2007-02-131130
K063475IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)Imc-Heart Way LLC2007-01-23680
K063474ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)Imc-Heart Way LLC2006-12-22360
K052008IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7Imc-Heart Way LLC2005-09-16530
K031897PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTERImc-Heart Way LLC2003-09-23960
K030432IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIRImc-Heart Way LLC2003-05-01800
K030427HP-3 HD ELECTRIC WHEELCHAIRImc-Heart Way LLC2003-04-18670

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