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Heartway Medical Products Co., Ltd.

FDA Regulatory Profile

Heartway Medical Products Co., Ltd. has 0 FDA recalls, 2 inspections, 23 510(k) clearances and 1 compliance action on record.

Latest inspection
Mar 11, 2015 · NAI
Latest 510(k)
Oct 12, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances23Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 11, 2015Taichung, TaiwanDevicesNo Action Indicated (NAI)3002847480
Oct 27, 2011Taichung, TaiwanDevicesNo Action Indicated (NAI)3002847480

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K220227Auto Folding Scooter, S21FOct 12, 2022
K151656HEARTWAY Power Mobility ScooterNov 25, 2015
K150998HEARTWAY Power Mobility ScooterSep 29, 2015
K150987HEARTWAY Power Mobility Scooter, BRIO S19Sep 22, 2015
K142783HEARTWAY Electrically Powered Wheelchair P27Jun 12, 2015
K142731HEARTWAY Electrically Powered WheelchairsFeb 27, 2015
K132855HEARTWAY POWER MOBILITY SCOOTERAug 29, 2014
K132856HEARTWAY POWER WHEELCHAIRJul 15, 2014
K101143HEARTWAY POWER MOBILITY SCOOTER, S11May 26, 2010
K101142HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34May 26, 2010
K100327HEARTWAY POWER CHAIR, P23Mar 22, 2010
K092650HEARTWAY POWER MOBILITY SCOOTER, S12Oct 9, 2009
K092154HEARTWAY POWER MOBILITY SCOOTER, S9Sep 21, 2009
K092155HEARTWAY POWER MOBILITY SCOOTER, S8Sep 21, 2009
K080242HEARTWAY POWER MOBILITY SCOOTER, PF7Feb 27, 2008
K073044HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7Dec 7, 2007
K072104HEARTWAY POWER MOBILITY SCOOTER, PF6Aug 17, 2007
K071005HEARTWAY LIGHTWEIGHT POWER CHAIR, P15May 22, 2007
K071006HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1May 21, 2007
K071007HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33Apr 19, 2007

FDA data resources