Sichuan AST Medical Equipment Co., Ltd.
Registered establishment in Luzhou, Sichuan, China. 18 device types, 3 clearances.
Sichuan AST Medical Equipment Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Crutch, Stand, Infusion and 16 other device types. Its earliest product listing with the FDA dates from 2009.
18device types registered with the FDA
3510(k) clearances
Registration
| Registered name | Sichuan AST Medical Equipment Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008058406 |
| FEI number | 3008058406 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Luzhou |
|---|---|
| Province | Sichuan |
| Address | No.58 ,Jin-Peng Road |
| Postal code | 646100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Wheelchair | Class 1 | Wheelchair Accessories | 2020 | 80 |
| Adaptor, Hygiene | Class 1 | Rehab Shower, Bathmat | 2024 | 193 |
| Attachment, Commode, Wheelchair | Class 1 | Commode chair (NRS185006, NRS185007, NRS185008) | 2021 | 70 |
| Chair, Adjustable, Mechanical | Class 1 | Full Tilt and Recliner | 2021 | 46 |
| Chair, With Casters | Class 1 | Chair with castor (CLN400-20, TR-1200-FR, TR-1200-JB, TR-1200-PP, TR-1400-FR, TR-1400-JB, TR-1400-PP, TR-1600-FR,, TR-1600-JB, TR-1600-PP, TR-1800-FR, TR-1800-JB, TR-1800-PP) | 2009 | 85 |
| Components, Wheelchair | Class 1 | wheelchair components | 2020 | 54 |
| Cover, Mattress (Medical Purposes) | Class 1 | mattress | 2020 | 89 |
| Crutch | Class 1 | Crutches | 2021 | 112 |
| Device, Anti-Tip, Wheelchair | Class 1 | Anti Tippers | 2024 | 22 |
| Device, Fixation, Tracheal Tube | Class 1 | Medical Fixation Strap Belt (A1:Catheter fixation (pediatric)/A2:Indwelling needle fixation/A3:Indwelling needle,, C2:Catheter and drainage tube fixation (pediatric)/C3:Central venous catheter tracheal intubation fixed/, D2:Peripheral venous catheter fixation patch(Thin film type)/L1:Nasogastric tube,nasogastric tube fixed (single tube)/, C6:Central venous catheter tracheal intubation fixed/D1:Peripheral venous catheter fixation patch/, A5:Retention needle fixation (Y type)/A6:Indwelling needle, peripheral IV catheter fixation/A7:Indwelling needle,, Gas cutting fixture(XW2023403)} and 8 more | 2023 | 46 |
| Footrest, Wheelchair | Class 1 | Limb Support | 2024 | 25 |
| Mask, Scavenging | Class 1 | Medical Mask | 2020 | 158 |
| Mattress, Water, Temperature Regulated | Class 1 | Gel overylay | 2020 | 1 |
| Non-Surgical Gown | Class 1 | Protective Clothing, AST-90A | 2020 | 318 |
| Stand, Infusion | Class 1 | IV Pole | 2010 | 75 |
| Strap, Head, Gas Mask | Class 1 | Philips Respironics Fit Life Headgear(XW2023106), Philips Respironics Amara view headgear(XW2023107),, Head strap hook(XW2023904), CPAP mask silicone pad(XW2023905)), Head strap and accessories(CPAP Strap(XW2023001/XW2023002/XW2023003),CPAP HEADGEAR(XW2023004/XW2023005/XW2023006/, XW2023007/XW2023008/XW2023009), P10 Nasal pillow headband(XW2023101), ResMed AirFit N20 Headgear(XW2023102),, Nuance Pro Headgear(XW2023108), Fisher & Paykel Simplus Headgear(XW2023109), Fisher & Paykel Vitera Headgear(XW2023110),, ResMed AirFit F20 Headgear(XW2023103), Dream Wear Headgear(XW2023104), Philips Respironics Wisp Headgear(XW2023105), and 1 more | 2023 | 29 |
| Walker, Mechanical | Class 1 | Rollator (RLA6BGF, RLA8BGF, RLA6BG, RLA8BG, RLA6BK, RLA8BK, RLA6BLF, RLA8BLF, RLA6BL, RLA8BL, 700-917, 700-917BK,, MD700935BK, MD700935BL, MD700935GN), 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,, Mechanical Walker | 2009 | 183 |
| Wheelchair, Mechanical | Class 1 | AST Model MA012 Rehab Wheelchair, AST Model MS019 Rehab Wheelchair, MA012 Aluminum Wheelchair, MS019 Steel Wheelchair, Guardian Wheelchair, Medline Wheelchair, Mechanical – IOR, Manual Wheelchair (MASY23), 28 bariatric wheelchair (MS010-1) and 4 more | 2010 | 46 |
Clearances
3 clearances name Sichuan AST Medical Equipment 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 |
|---|---|---|---|---|
| K242722 | 2024-11-22 | IOR | Traditional | This company |
| K231750 | 2023-08-15 | IOR | Traditional | This company |
| K181795 | 2018-09-25 | IOR | Traditional | This company |
| K094047 | 2010-03-22 | IOR | Traditional | Modern Rehabilitation Solutions Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Factory area | 50,000 square meters |
| Main products | Wheelchairs, Walking aids, Rehabilitation equipment |
| Certifications | ISO 9001 |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Auckland Medical Technology (Sichuan) Co., Ltd. | 3 |
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.