Data / Medical devices / Taiwan / Heartway Medical Products Co., Ltd.
Heartway Medical Products Co., Ltd.: FDA-registered device maker in Taichung City, Taiwan, 27 510(k) clearances
Heartway Medical Products Co., Ltd. is registered with the FDA (registration 9616881) in Taichung City, Taiwan. It lists 11 device types. The FDA files 27 510(k) clearances under its listings, the newest dated October 12, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9616881
- FEI number
- 3002847480
- Address
- No. 6, Gongyequ 25th Rd., Baoshan Vil. Nantun Dist., Taichung City, Taiwan, 408017
- Owner or operator
- HEARTWAY MEDICAL PRODUCTS CO., LTD. (9030564)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 21, 1998
- Registered through
- 2027
- Brand names listed
- BRIO S19 Scooter, Cute Mini S16 Scooter, HEARTWAY, HEARTWAY Auto Folding Scooter, S21F, HEARTWAY Electrically Powered Wheelchair P27, HEARTWAY Electrically Powered Wheelchair, Model P19, HEARTWAY HP6, HEARTWAY Power Mobility Scooter, Cutie S17 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Armrest, Wheelchair | IML | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Brake, Extension, Wheelchair | IMW | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Device, Anti-Tip, Wheelchair | IMR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Footrest, Wheelchair | IMM | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Handrim, Wheelchair | IMO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Holder, Crutch And Cane, Wheelchair | IMZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Vehicle, Motorized 3-Wheeled | INI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 12, 2022 | K220227 | Auto Folding Scooter, S21F | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| November 25, 2015 | K151656 | HEARTWAY Power Mobility Scooter | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| September 29, 2015 | K150998 | HEARTWAY Power Mobility Scooter | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| September 22, 2015 | K150987 | HEARTWAY Power Mobility Scooter, BRIO S19 | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| June 12, 2015 | K142783 | HEARTWAY Electrically Powered Wheelchair P27 | ITI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| February 27, 2015 | K142731 | HEARTWAY Electrically Powered Wheelchairs | ITI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| August 29, 2014 | K132855 | HEARTWAY POWER MOBILITY SCOOTER | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| July 15, 2014 | K132856 | HEARTWAY POWER WHEELCHAIR | ITI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| May 26, 2010 | K101143 | HEARTWAY POWER MOBILITY SCOOTER, S11 | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| May 26, 2010 | K101142 | HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34 | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| March 22, 2010 | K100327 | HEARTWAY POWER CHAIR, P23 | ITI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| October 9, 2009 | K092650 | HEARTWAY POWER MOBILITY SCOOTER, S12 | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| September 21, 2009 | K092155 | HEARTWAY POWER MOBILITY SCOOTER, S8 | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| September 21, 2009 | K092154 | HEARTWAY POWER MOBILITY SCOOTER, S9 | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| February 27, 2008 | K080242 | HEARTWAY POWER MOBILITY SCOOTER, PF7 | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| December 7, 2007 | K073044 | HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7 | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| August 17, 2007 | K072104 | HEARTWAY POWER MOBILITY SCOOTER, PF6 | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| May 22, 2007 | K071005 | HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 | ITI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| May 21, 2007 | K071006 | HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 | ITI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| April 27, 2007 | K063328 | IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) | ITI | Substantially Equivalent | Imc-Heart Way LLC | accessdata.fda.gov |
| April 19, 2007 | K071007 | HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| March 23, 2007 | K070493 | HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT | INI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| March 14, 2007 | K070489 | HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT | ITI | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
| February 13, 2007 | K063203 | ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) | ITI | Substantially Equivalent | Imc-Heart Way LLC | accessdata.fda.gov |
| September 23, 2003 | K031897 | PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER | INI | Substantially Equivalent | Imc-Heart Way LLC | accessdata.fda.gov |
| March 21, 2002 | K020001 | PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3 | INI | Substantially Equivalent | Transworld Mobility Distribution, LLC | accessdata.fda.gov |
| December 4, 1997 | K973491 | MECHANICAL FOLDING WHEEL CHAIR | IOR | Substantially Equivalent | Heartway Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Vehicle, Motorized 3-Wheeled
- All makers of Accessories, Wheelchair
- All makers of Wheelchair, Powered
- All makers of Components, Wheelchair
- All makers of Brake, Extension, Wheelchair
- All makers of Handrim, Wheelchair
Updated October 12, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.