Data / Medical devices / China / Intradin (shanghai) Machinery Co., Ltd
Intradin (shanghai) Machinery Co., Ltd: FDA-registered device maker in Shang Hai Shanghai, China, 4 510(k) clearances
Intradin (shanghai) Machinery Co., Ltd is registered with the FDA (registration 3012781455) in Shang Hai Shanghai, China. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012781455
- Address
- No. 118, Duhui Road, Minhang District, Shang Hai Shanghai, China, 201199
- Owner or operator
- INTRADIN (SHANGHAI) MACHINERY CO., LTD (10091096)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- June 30, 2024
- Registered through
- 2026
- Brand names listed
- Bath Lift Cushion: ATD302, GUT194, GCAT068, GCAT059, ATD301, GUT189, GCAT061, GCAT041, GCAT042;, Lift Chair: ATD106, GUT206, GCAT069, Lift Chair: ATD106, GUT212, GCAT073, PMS106, PMS107, PMS108;, Portable Floor Lift: GUT195, GUT197, GCAT044, GCAT060, Superhandy Electrically Power Wheelchairs, Superhandy Floor Lift: ATD101, GUT167, ATD102, GUT168, ATD103, GUT170, ATD104, GUT169, GCAT046, ATD105, GUT201, and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Transfer | IKX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Holder, Crutch And Cane, Wheelchair | IMZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lift, Patient, Ac-Powered | FNG | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Vehicle, Motorized 3-Wheeled | INI | 2 | 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 |
|---|---|---|---|---|---|---|
| March 7, 2025 | K243970 | Portable Wheelchair | ITI | Substantially Equivalent | Intradin (Shanghai) Machinery Co., Ltd. | accessdata.fda.gov |
| February 21, 2025 | K250027 | Powered Mobility Scooter | INI | Substantially Equivalent | Intradin (Shanghai) Machinery Co., Ltd. | accessdata.fda.gov |
| September 5, 2024 | K232692 | Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) | INI | Substantially Equivalent | Intradin (Shanghai) Machinery Co., Ltd. | accessdata.fda.gov |
| September 22, 2023 | K232193 | Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) | ITI | Substantially Equivalent | Yurob Rehabilitation Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Vehicle, Motorized 3-Wheeled
- All makers of Wheelchair, Powered
- All makers of Lift, Patient, Non-Ac-Powered
- All makers of Holder, Crutch And Cane, Wheelchair
- All makers of Components, Wheelchair
- All makers of Aid, Transfer
Updated March 7, 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.