Sichuan AST Medical Equipment Co., Ltd

FDA Device Registration & Listing · Luzhou City Sichuan, CN · Registration 3008058406

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008058406
FEI Number
3008058406
Entity Name
Sichuan AST Medical Equipment Co., Ltd
City/State/Country
Luzhou City Sichuan, CN
Establishment Address
No.58 ,Jin-Peng Road, C area, Luxian Industrial Park, Luzhou City Sichuan 646100, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Sichuan AST Medical Equipment Co., Ltd (Owner Number: 10030716)
Owner / Operator Contact Address
No. 58, Jin-Peng Road, C area, Luxian Industrial Park, Luzhou City, CN-SC 646100, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

WHEELCHAIR ACCESSORIES MA012 Aluminum Wheelchair, MS019 Steel Wheelchair Commode chair (NRS185006, NRS185007, NRS185008) Crutches AST Model MA012 Rehab Wheelchair AST Model MS019 Rehab Wheelchair mattress 700-920, 700-921, 700-922, 700-927, 700-928, 700-929, 700-932, 700-932PB, 700-935, 700-935BK, 700-935CR, 700-938, MD700935BK, MD700935BL, MD700935GN) 700-957, 700-959, 700-959E, 700-961, 700-977, 700-979, 700-920PR, MD700920BK, MD700920BL, MD700920PR, MD700929BL, Rollator (RLA6BGF, RLA8BGF, RLA6BG, RLA8BG, RLA6BK, RLA8BK, RLA6BLF, RLA8BLF, RLA6BL, RLA8BL, 700-917, 700-917BK, Mechanical Walker Manual Wheelchair (MASY23) wheelchair components LIMB SUPPORT IV Pole Medical Mask Medical Fixation Strap Belt (A1:Catheter fixation (pediatric)/A2:Indwelling needle fixation/A3:Indwelling needle, central venous catheter fixation/B1:Peripheral IV catheter, indwelling needle fixation/B2:Peripheral IV catheter, indwelling needle fixation/B3:Central venous catheter fixation double lumen)/C1:Catheter and drainage tube fixation/ 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/ L2:Nasogastric tube, nasogastric tube fixed (double tube)/ L4:Nasogastric tube,nasogastric tube fixed (pediatric double tube)) C4:Catheter and drainage tube fixation/C5:Central venous catheter tracheal intubation fixed/ A5:Retention needle fixation (Y type)/A6:Indwelling needle, peripheral IV catheter fixation/A7:Indwelling needle, C2:Catheter and drainage tube fixation (pediatric)/C3:Central venous catheter tracheal intubation fixed/ L3:Nasogastric tube, nasogastric tube fixed (pediatric single tube)/ central venous catheter fixation/A4:Indwelling needle, peripheral IV catheter fixation/ Gas cutting fixture(XW2023403)} Gas cutting device{Gas cut fixed Strap(XW2023401), Tracheal intubation fixation(XW2023402), Head strap hook(XW2023904), CPAP mask silicone pad(XW2023905)) ResMed AirFit F20 Headgear(XW2023103), Dream Wear Headgear(XW2023104), Philips Respironics Wisp Headgear(XW2023105), XW2023007/XW2023008/XW2023009), P10 Nasal pillow headband(XW2023101), ResMed AirFit N20 Headgear(XW2023102), Philips Respironics Fit Life Headgear(XW2023106), Philips Respironics Amara view headgear(XW2023107), CPAP head strap anti-mark pad(XW2023901), Non-slip sleeve for nasal mask(XW2023902), Mask hose protector(XW2023903), Nuance Pro Headgear(XW2023108), Fisher & Paykel Simplus Headgear(XW2023109), Fisher & Paykel Vitera Headgear(XW2023110), Head strap and accessories(CPAP Strap(XW2023001/XW2023002/XW2023003),CPAP HEADGEAR(XW2023004/XW2023005/XW2023006/ 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) Guardian Wheelchair, Medline Wheelchair, Mechanical - IOR REHAB SHOWER, BATHMAT Gel overylay Full Tilt and Recliner

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNO Accessories, Wheelchair Physical Medicine Class 1 890.3910 2020-12-16
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2023-11-30
INB Attachment, Commode, Wheelchair Physical Medicine Class 1 890.3920 2021-11-12
IPR Crutch Physical Medicine Class 1 890.3150 2021-11-12
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2018-10-15
FMW Cover, Mattress (Medical Purposes) General Hospital Class 1 880.6190 2020-07-22
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2009-11-03
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2024-11-25
KNN Components, Wheelchair Physical Medicine Class 1 890.3920 2020-12-16
IMM Footrest, Wheelchair Physical Medicine Class 1 890.3920 2024-01-29
FOX Stand, Infusion General Hospital Class 1 880.6990 2010-01-15
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2020-03-09
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2023-08-01
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2023-08-01
INM Chair, With Casters Physical Medicine Class 1 890.3100 2009-11-03
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2025-08-22
ILS Adaptor, Hygiene Physical Medicine Class 1 890.5050 2024-01-29
FOH Mattress, Water, Temperature Regulated General Hospital Class 1 880.5560 2020-07-22
INN Chair, Adjustable, Mechanical Physical Medicine Class 1 890.3100 2021-11-12

Official Correspondent

Michelle Chu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Sichuan AST Medical Equipment Co., Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935211 Brookefield Hunter, Inc. WALK N CHAIR 1994-02-02
K832685 Health America WHEELCHAIR-VARIOUS MODELS 1983-09-20
K830425 Maddak, Inc. TOILET SEAT RAISED 1983-05-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2015 Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056 1
Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013 Winco Mfg., LLC 1
Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair
Z-0032-2013 Winco Mfg., LLC 1
Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008058406. Last updated year: 2026. Please use registration number 3008058406 when referencing this establishment in official correspondence.
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