Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019505063

FEI Number

3019505063

Entity Name

FOSHAN SHUNKANGDA MEDICAL TECH CO.,LTD

City/State/Country

FOSHAN CITY Guangdong, CN

Establishment Address

PINGNAN INDUSTRIAL AREA, GUICHENG NANHAI DISTRICT, FOSHAN CITY Guangdong 528251, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FOSHAN SHUNKANGDA MEDICAL TECH CO.,LTD (Owner Number: 10084655)

Owner / Operator Contact Address

PINGNAN INDUSTRIAL AREA, GUICHENG NANHAI DISTRICT, FOSHAN CITY, CN-GD 528251, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CPR Mask Grab Bar Bath Rail Over Bed Table Crutch Manual Bed Bed Rail MEDICAL DEPOT d/b/a Drive DeVilbiss Healthcare ALEX ORTHOPEDIC, INC PCP CHAMPION Showerbuddy LLC F-017 F-001E Fb-2518 F-002 FB-012D Fb-4312B F-005B AF-005A EX-2 F-019A F-004 WM-KS#XL F-016A #XLWM-KS Fb-012E #S F-001A F-016 F-016B FB-012A WA-0203HA FB-012 WA-0203HC WM-0203HA EX-1 FB-012B F-001B F-001C F-016C WM-0203HC FB-011A Fb-4312A Fb-012E #L WM-0203HB SH-0213L F-003 Fb-012H # M WM-KS#S F-019D SH-0214 F-008 F-006 F-018A Fb-012E #XL F-010 F-017C F-009 Fb-012H #S WM-KS#M F-002B F-019 WM-KS#L SH-0212 F-001D RC-900 CH-0209 CH-0505C H-300 CH-350 CH-0204C #L RH-013 CH-200 CH-0219 CH-0504C RH030 CH-280 RC-3 SH-0207C RH-012 C-200 SH-0215E CH-060 SH-0215B CH-0206 RC-500 SH-0215A RH-011 SH0215D CH250 RC-1000C CH-100 CH-180 RC-3025 CH-280B RH-1500 RC-2 RC-100 CH-1000B RH-1400 RC-1000B CH-260B CH-120 RC 4x50 RH-500 RC-4 Single Layer RC-350 RH-450 SH-0207B CH-0217 CH-010 CH-0502C RH-800 RC-1714 RH-050 CH-0202C #S CH-250B SH-0213#S RC-300 CH-300B CH-320B RH-600 CH-030 SH-0211-7 CH-0202C #L CH-160 CH-0501C RC-550 CH-0218 RH-550 CH-0208 CH-0503C SH-0213#L CH-0201C #S CH-020 RC-450 RC-250 C-300 RC-2418 RC-1 RC-4330 CH-8080B SH-0215C RH-020 CH-0506C RH-1200 Double Layer CH-550N CH-0201C #L SH-0212 CH-040 CH-180B CH-0204C #S RH040 CH-400N CH-0205C CH-260 RC-1000J SH-0207A CH-450 SH-0207D RC-800 RH-400 RH-010 SH-0214 Transport Chair Cane

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2022-03-17
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2022-03-17
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2022-03-17
IPR	Crutch	Physical Medicine	Class 1	890.3150	2022-03-17
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2022-03-17
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2022-03-17
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2022-03-17
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2022-03-17
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2022-03-17
IPS	Cane	Physical Medicine	Class 1	890.3075	2022-03-17

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

FOSHAN SHUNKANGDA MEDICAL TECH CO.,LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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 WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase 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'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase 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'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly 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 3019505063. Last updated year: 2026. Please use registration number 3019505063 when referencing this establishment in official correspondence.