510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Heartway Medical Products Co., Ltd.

Taichung City, TW

HEARTWAY MEDICAL PRODUCTS CO., LTD. appears in FDA device records in Taichung City, TW. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
23
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 23 510(k) clearances for Heartway Medical Products Co., Ltd. between 1997 and 2022. The busiest year on record is 2007, with 7. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for Heartway Medical Products Co., Ltd., by decision year
YearClearances
19971
20077
20081
20093
20103
20142
20155
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220227Auto Folding Scooter, S21FINISubstantially Equivalent
K151656HEARTWAY Power Mobility ScooterINISubstantially Equivalent
K150998HEARTWAY Power Mobility ScooterINISubstantially Equivalent
K150987HEARTWAY Power Mobility Scooter, BRIO S19INISubstantially Equivalent
K142783HEARTWAY Electrically Powered Wheelchair P27ITISubstantially Equivalent
K142731HEARTWAY Electrically Powered WheelchairsITISubstantially Equivalent
K132855HEARTWAY POWER MOBILITY SCOOTERINISubstantially Equivalent
K132856HEARTWAY POWER WHEELCHAIRITISubstantially Equivalent
K101143HEARTWAY POWER MOBILITY SCOOTER, S11INISubstantially Equivalent
K101142HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34INISubstantially Equivalent
K100327HEARTWAY POWER CHAIR, P23ITISubstantially Equivalent
K092650HEARTWAY POWER MOBILITY SCOOTER, S12INISubstantially Equivalent
K092155HEARTWAY POWER MOBILITY SCOOTER, S8INISubstantially Equivalent
K092154HEARTWAY POWER MOBILITY SCOOTER, S9INISubstantially Equivalent
K080242HEARTWAY POWER MOBILITY SCOOTER, PF7INISubstantially Equivalent
K073044HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7INISubstantially Equivalent
K072104HEARTWAY POWER MOBILITY SCOOTER, PF6INISubstantially Equivalent
K071005HEARTWAY LIGHTWEIGHT POWER CHAIR, P15ITISubstantially Equivalent
K071006HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1ITISubstantially Equivalent
K071007HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33INISubstantially Equivalent
K070493HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RTINISubstantially Equivalent
K070489HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RTITISubstantially Equivalent
K973491MECHANICAL FOLDING WHEEL CHAIRIORSubstantially Equivalent

Registered establishments

FDA registered establishments for Heartway Medical Products Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96168813002847480HEARTWAY MEDICAL PRODUCTS CO., LTD.No. 6, Gongyequ 25th Rd., Baoshan Vil., TAICHUNG CITY 408017 TW2026and 1 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain