Data / Medical devices / China / Sichuan AST Medical Equipment Co., Ltd
Sichuan AST Medical Equipment Co., Ltd: FDA-registered device maker in Luzhou City Sichuan, China, 4 510(k) clearances
Sichuan AST Medical Equipment Co., Ltd is registered with the FDA (registration 3008058406) in Luzhou City Sichuan, China. It lists 18 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 22, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008058406
- Address
- No.58,Jin-Peng Road C area, Luxian Industrial Park, Luzhou City Sichuan, China, 646100
- Owner or operator
- Sichuan AST Medical Equipment Co., Ltd (10030716)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 3, 2009
- Registered through
- 2026
- Brand names listed
- 14¿ pediatric wheelchair (MS011-1), 18¿ reclining wheelchair (MS008-1), 18¿ standard wheelchair (MS005-4), 22¿ heavy duty wheelchair (MS006-2), 28¿ bariatric wheelchair (MS010-1), 700-920, 700-921, 700-922, 700-927, 700-928, 700-929, 700-932, 700-932PB, 700-935, 700-935BK, 700-935CR, 700-938,, 700-957, 700-959, 700-959E, 700-961, 700-977, 700-979, 700-920PR, MD700920BK, MD700920BL, MD700920PR, MD700929BL,, A5:Retention needle fixation (Y type)/A6:Indwelling needle, peripheral IV catheter fixation/A7:Indwelling needle, and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 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 |
| Attachment, Commode, Wheelchair | INB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Chair, Adjustable, Mechanical | INN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Chair, With Casters | INM | 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 |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Crutch | IPR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Device, Anti-Tip, Wheelchair | IMR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Footrest, Wheelchair | IMM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mattress, Water, Temperature Regulated | FOH | 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 |
| Stand, Infusion | FOX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 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 |
|---|---|---|---|---|---|---|
| November 22, 2024 | K242722 | Manual Wheelchair (MASY23) | IOR | Substantially Equivalent | Sichuan Ast Medical Equipment Co., Ltd. | accessdata.fda.gov |
| August 15, 2023 | K231750 | MA012 Aluminum wheelchair, MS019 steel wheelchair | IOR | Substantially Equivalent | Sichuan Ast Medical Equipment Co., Ltd. | accessdata.fda.gov |
| September 25, 2018 | K181795 | AST Model MA012 and MS019 Rehab Wheelchair | IOR | Substantially Equivalent | Sichuan Ast Medical Equipment Co., Ltd. | accessdata.fda.gov |
| March 22, 2010 | K094047 | 18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR | IOR | Substantially Equivalent | Modern Rehabilitation Solutions Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Hygiene
- All makers of Wheelchair, Mechanical
- All makers of Chair, Adjustable, Mechanical
- All makers of Mask, Scavenging
- All makers of Accessories, Wheelchair
- All makers of Strap, Head, Gas Mask
Updated November 22, 2024. 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.