Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012781455

FEI Number

3012781455

Entity Name

INTRADIN (SHANGHAI) MACHINERY CO., LTD

City/State/Country

Shang Hai Shanghai, CN

Establishment Address

No. 118, Duhui Road, Minhang District,, Shang Hai Shanghai 201199, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

INTRADIN (SHANGHAI) MACHINERY CO., LTD (Owner Number: 10091096)

Owner / Operator Contact Address

No. 118, Duhui Road, Minhang District,, Shang Hai, CN-NOTA 201199, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232193

PMA Number

N/A

All Registered Proprietary Names

Portable Floor Lift: GUT195, GUT197, GCAT044, GCAT060 GCAT059, ATD301, GUT189, GCAT061, GCAT041, GCAT042; Superhandy Floor Lift: ATD101, GUT167, ATD102, GUT168, ATD103, GUT170, ATD104, GUT169, GCAT046, ATD105, GUT201, Superhandy Portable Wheelchair: GUT166, PMS302, GCAT043 Superhandy Powered Mobility Scooter: PMS101, GUT112, PMS103, GUT140, PMS102, GUT161, PMS104, GUT164, GUT165, PSM105, Superhandy Portable Wheelchair: PMS302, GUT166, PMS303, PMS304, PMS305, PMS306 PMS106, PMS107, PMS108; Superhandy Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) Superhandy Lift Cushion: ATD301, GUT189, GCAT061 Superhandy Electrically Power Wheelchairs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2024-06-30
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2025-04-23
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2024-06-30
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2024-09-26
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2026-04-10
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2024-06-30

Official Correspondent

Mark Lee

US Agent Details

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

Related Public Records

Same Entity

INTRADIN (SHANGHAI) MACHINERY 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
K853594	Vessa , Ltd.	VESSA FLIVVA	1985-09-24
K142783	Heartway Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Z-0005-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012781455. Last updated year: 2026. Please use registration number 3012781455 when referencing this establishment in official correspondence.