Intradin (Shanghai) Machinery Co., Ltd.
Registered establishment in Shang Hai, Shanghai, China. 7 device types, 4 clearances.
Intradin (Shanghai) Machinery Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Aid, Transfer, Wheelchair, Powered and 5 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | INTRADIN (SHANGHAI) MACHINERY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012781455 |
| FEI number | 3012781455 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 士商（上海）机械有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Shang Hai |
|---|---|
| Province | Shanghai |
| Address | No. 118, Duhui Road, Minhang District, |
| Postal code | 201199 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Aid, Transfer | Class 1 | Bath Lift Cushion: ATD302, GUT194, GCAT068, Superhandy Lift Cushion: ATD301, GUT189, GCAT061 | 2026 | 118 |
| Components, Wheelchair | Class 1 | PMS106, PMS107, PMS108;, Superhandy Portable Wheelchair: PMS302, GUT166, PMS303, PMS304, PMS305, PMS306, Superhandy Powered Mobility Scooter: PMS101, GUT112, PMS103, GUT140, PMS102, GUT161, PMS104, GUT164, GUT165, PSM105, | 2024 | 54 |
| Holder, Crutch And Cane, Wheelchair | Class 1 | Superhandy Portable Wheelchair: PMS302, GUT166, PMS303, PMS304, PMS305, PMS306 | 2024 | 22 |
| Lift, Patient, Ac-Powered | Class 2 | Lift Chair: ATD106, GUT212, GCAT073 | 2026 | 27 |
| Lift, Patient, Non-Ac-Powered | Class 1 | GCAT059, ATD301, GUT189, GCAT061, GCAT041, GCAT042;, Lift Chair: ATD106, GUT206, GCAT069, Portable Floor Lift: GUT195, GUT197, GCAT044, GCAT060, Superhandy Floor Lift: ATD101, GUT167, ATD102, GUT168, ATD103, GUT170, ATD104, GUT169, GCAT046, ATD105, GUT201, | 2024 | 71 |
| Vehicle, Motorized 3-Wheeled | Class 2 | Superhandy Powered Mobility Scooter: GUT161, PMS102, GCAT039, GUT164, GUT165, PMS104, GCAT040, Superhandy Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) | 2024 | 41 |
| Wheelchair, Powered | Class 2 | Superhandy Portable Wheelchair: GUT166, PMS302, GCAT043, Superhandy Electrically Power Wheelchairs | 2024 | 62 |
Clearances
4 clearances name Intradin (Shanghai) Machinery Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252590 | 2025-11-21 | INI | Traditional | This company |
| K243970 | 2025-03-07 | ITI | Traditional | This company |
| K250027 | 2025-02-21 | INI | Special | This company |
| K232692 | 2024-09-05 | INI | Traditional | This company |
| K232193 | 2023-09-22 | ITI | Traditional | Yurob Rehabilitation Medical Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1994 |
|---|---|
| Employees | 700+ |
| Main products | Hose reels, Hydraulic cylinders, Pumps, Outdoor power equipment |
| Certifications | ISO 9001:2015 |
| Export markets | 100+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Shanghai Suokang Medical Implants Co., Ltd. | 2 |
| Shanghai Fimet Medical Instrument Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.