Data / Medical devices / China / Jiaxing Xinyi Medical Instrument Co., Ltd.
Jiaxing Xinyi Medical Instrument Co., Ltd.: FDA-registered device maker in Jiashan City Zhejiang, China, 1 510(k) clearance
Jiaxing Xinyi Medical Instrument Co., Ltd. is registered with the FDA (registration 3011669224) in Jiashan City Zhejiang, China. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 15, 1999. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011669224
- Address
- No.15,Jinyi Road,(1)and No.100 Zhijiang Road, (2) Economic Development Zone Jiashan City Zhejiang, CHINA, Jiashan City Zhejiang, China, 314100
- Owner or operator
- Jiaxing Xinyi Medical Instrument Co., Ltd. (10049114)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- April 15, 2015
- Registered through
- 2026
- Brand names listed
- Crutch, Isolation Gown, Protective clothing, Wheelchair, aluminum commode, aluminum rollator, aluminum shower chair with backrest, aluminum walker with castors and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Adaptor, Hygiene | ILS | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bed, Manual | FNJ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cane | IPS | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Crutch | IPR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Table, Mechanical | INW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tips And Pads, Cane, Crutch And Walker | INP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Contract manufacturer, 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 15, 1999 | K990463 | MEDLINE EXCEL WHEELCHAIRS | IOR | Substantially Equivalent | Medline | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Hygiene
- All makers of Mask, Scavenging
- All makers of Bed, Manual
- All makers of Crutch
- All makers of Tips And Pads, Cane, Crutch And Walker
- All makers of Cane
Updated March 15, 1999. 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.