Data / Medical devices / Taiwan / Merits Health Products Co., Ltd.
Merits Health Products Co., Ltd.: FDA-registered device maker in Taichung City, Taiwan, 15 510(k) clearances
Merits Health Products Co., Ltd. is registered with the FDA (registration 9680333) in Taichung City, Taiwan. It lists 23 device types. The FDA files 15 510(k) clearances under its listings, the newest dated March 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680333
- FEI number
- 1000334118
- Address
- No. 18, Jingke RD., T.P.M.T. Park Nantun District, Taichung City, Taiwan, 40852
- Owner or operator
- MERITS HEALTH PRODUCTS CO., LTD. (9008298)
- Roles
- Manufacturer
- First device listed
- March 12, 2003
- Registered through
- 2026
- Brand names listed
- ARMBOARD, WHEELCHAIR, ARMREST, WHEELCHAIR, BELT, WHEELCHAIR, BOARD, LAP, WHEELCHAIR, BOARD, SCOOTER, PRONE, BRAKE, EXTENSION, WHEELCHAIR, CANE~PHYSICAL MEDICINE, CHAIR, ADJUSTABLE, MECHANICAL and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| March 18, 2022 | K220529 | Merits P335 Powered Wheelchair | ITI | Substantially Equivalent | Merits Health Products Co., Ltd. | accessdata.fda.gov |
| November 29, 2017 | K170634 | Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 | INI | Substantially Equivalent | Advanced Vehicle Concepts , Ltd. | accessdata.fda.gov |
| June 23, 2015 | K142912 | Merits Yoga Power Scooter, S542 | INI | Substantially Equivalent | Merits Health Products Co., Ltd. | accessdata.fda.gov |
| May 1, 2015 | K142162 | MERITS TRANSFORMER POWER SCOOTER, S941 | INI | Substantially Equivalent | Merits Health Products Co., Ltd. | accessdata.fda.gov |
| January 9, 2013 | K122357 | MERITS MODEL P322FWD POWERED WHEELCHAIR | ITI | Substantially Equivalent | Merits Health Products Co., Ltd. | accessdata.fda.gov |
| May 8, 2012 | K113577 | MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR | ITI | Substantially Equivalent | Merits Health Products Co., Ltd. | accessdata.fda.gov |
| September 18, 2001 | K012802 | MP3CF ELECTRIC WHEELCHAIR | ITI | Substantially Equivalent | Merits Health Products., Inc. | accessdata.fda.gov |
| August 10, 2001 | K011513 | MP3U, POWER WHEELCHAIR | ITI | Substantially Equivalent | Merits Health Products., Inc. | accessdata.fda.gov |
| August 6, 2001 | K011751 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3 | INI | Substantially Equivalent | Merits Health Products., Inc. | accessdata.fda.gov |
| August 3, 2001 | K011753 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4 | INI | Substantially Equivalent | Merits Health Products., Inc. | accessdata.fda.gov |
| August 3, 2001 | K011707 | TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2 | INI | Substantially Equivalent | Merits Medical Industries Co., Ltd. | accessdata.fda.gov |
| August 3, 2001 | K011687 | MP-3C POWER BASE CHAIR, MODEL MP3C | ITI | Substantially Equivalent | Merits Health Products., Inc. | accessdata.fda.gov |
| May 9, 2001 | K010380 | MP3HD BIG BOY, POWER WHEELCHAIR | ITI | Substantially Equivalent | Merits Health Products., Inc. | accessdata.fda.gov |
| November 5, 1999 | K993032 | MODIFICATION TO MP-3 POWER BASE CHAIR | ITI | Substantially Equivalent | Merits Health Products., Inc. | accessdata.fda.gov |
| March 4, 1996 | K952042 | TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER | INI | Substantially Equivalent | Merits Health Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Powered
- All makers of Board, Scooter, Prone
- All makers of Armrest, Wheelchair
- All makers of Restraint, Wheelchair, Non-Protective
- All makers of Belt, Wheelchair
- All makers of Cane
Updated March 18, 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.