Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSuzhou Master Machinery Manufacturing Co., Ltd
US
Last updated May 31, 2026
What Suzhou Master Machinery Manufacturing Co., Ltd makes
Suzhou Master Machinery Manufacturing Co., Ltd produces electric-motor-driven assistive scooters, including models like the So Lite S1 Scooter and HS186B Scooter, designed for mobility assistance. Their portfolio also includes manual and electric wheelchairs, such as the HM305-Air series, MP148, MP201C, and MP201L, as well as additional mobility scooters like the MS160C and MS160A.
These devices are regulated under FDA classifications, with some falling under Class I and others under Class II. They are listed in the FDA’s 510(k) and UDI registries. The company is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Suzhou Master Machinery Manufacturing Co., Ltd primarily manufacture?
Suzhou Master Machinery Manufacturing Co., Ltd specializes in mobility assistance devices, focusing on electric-motor-driven assistive scooters like the So Lite S1 and HS186B. Their portfolio also includes manual and electric wheelchairs, such as the HM305-Air series, MP148, MP201C, and MP201L, as well as additional mobility scooters like the MS160C and MS160A. These devices are designed to aid individuals with limited mobility.
Where is Suzhou Master Machinery Manufacturing Co., Ltd based?
The company is based in the United States. This location is relevant for regulatory compliance and distribution, particularly when submitting devices to US regulatory bodies like the FDA.
Which regulatory registries list devices manufactured by Suzhou Master Machinery Manufacturing Co., Ltd?
Devices from Suzhou Master Machinery Manufacturing Co., Ltd are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. The 510(k) registry is used to demonstrate substantial equivalence to existing devices, while the UDI system ensures traceability and identification of medical devices in the market.
How are devices from Suzhou Master Machinery Manufacturing Co., Ltd classified under FDA regulations?
The company’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. Classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 543596952
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| So Lite S1 Scooter | HS186B | FDA UDI | Class II | Active |
| Mobility Scooter (MS160C) | K251638 | FDA 510(k) | Class II | Active |
| Manual Wheelchair (HM305-Air1, HM305-Air2) | K252687 | FDA 510(k) | Class I | Active |
| Electric Wheelchair (MP148) | K253870 | EUDAMEDFDA 510(k) | Class II | Active |
| Electric Wheelchair (MP201C); Electric Wheelchair (MP201L) | K241463 | FDA 510(k) | Class II | Active |
| HS186B Scooter | K222711 | FDA 510(k) | Class II | Active |
| Mobility Scooter (MS160A) | K242982 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Suzhou Master Machinery Manufacturing Co., Ltd. Kunshan Jiangsu · CN FEI 3014489639