Data / Medical devices / China / Suzhou Master Machinery Manufacturing Co.,ltd.
Suzhou Master Machinery Manufacturing Co.,ltd.: FDA-registered device maker in Kunshan Jiangsu, China, 4 510(k) clearances
Suzhou Master Machinery Manufacturing Co.,ltd. is registered with the FDA (registration 3014489639) in Kunshan Jiangsu, China. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014489639
- Address
- No. 379,Jujin Road, Zhangpu Town, Kunshan Jiangsu, China, 215321
- Owner or operator
- Suzhou Master Machinery Manufacturing Co.,Ltd. (10087245)
- Roles
- Manufacturer
- First device listed
- February 1, 2023
- Registered through
- 2026
- Brand names listed
- Electric Wheelchair (MP201C); Electric Wheelchair (MP201L), HS186B Scooter, MOBILITY SCOOTER, Mobility Scooter (MS160A), Mobility Scooter (MS160C), Rollator: HR201, HR203, HR204, HR205, HR200
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | 2 | Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | 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 |
|---|---|---|---|---|---|---|
| July 22, 2025 | K251638 | Mobility Scooter (MS160C) | INI | Substantially Equivalent | Suzhou Master Machinery Manufacturing Co.,Ltd | accessdata.fda.gov |
| January 31, 2025 | K242982 | Mobility Scooter (MS160A) | INI | Substantially Equivalent | Suzhou Master Machinery Manufacturing Co.,Ltd | accessdata.fda.gov |
| July 18, 2024 | K241463 | Electric Wheelchair (MP201C); Electric Wheelchair (MP201L) | ITI | Substantially Equivalent | Suzhou Master Machinery Manufacturing Co.,Ltd | accessdata.fda.gov |
| January 9, 2023 | K222711 | HS186B Scooter | INI | Substantially Equivalent | Suzhou Master Machinery Manufacturing Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Vehicle, Motorized 3-Wheeled
- All makers of Walker, Mechanical
- All makers of Wheelchair, Powered
Updated July 22, 2025. 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.