Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007774549

FEI Number

3007774549

Entity Name

Shanghai Leison Medical & Healthcare Products Co., Ltd

City/State/Country

Shanghai, CN

Establishment Address

No.99, West Puhong Road, Zhuqiao Town, Pudong New Area, Shanghai 201324, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Leison Medical & Healthcare Products Co., Ltd (Owner Number: 10030026)

Owner / Operator Contact Address

No.99, West Puhong Road, Zhuqiao Town, Pudong New Area, Shanghai, CN-SH 201324, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BACK/LEG/HEEL/FOORT/TOE CUSHION, SILICON CUSHION Cold Treatmeat System, Cold Therapy Pelvic Support Limb Holder Quick Release, Body Holder Splint, Extremity, Inflatable, External Bunion Splint; Dorsal Night Splint; Night Splint; Plantar Fascitic Soft Night Splint Ice Bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2009-08-01
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2009-08-01
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2009-08-01
ITM	Cage, Knee	Physical Medicine	Class 1	890.3475	2015-12-16
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2014-12-16
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2009-08-01
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2014-12-16
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2017-11-09
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2009-08-01
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2017-11-09
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2009-08-01
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2009-08-01
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2009-08-01
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2015-12-16
IQM	Splint, Temporary Training	Physical Medicine	Class 1	890.3025	2015-12-16
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2014-12-16
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2009-08-01
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2009-08-01
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2009-08-01
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2009-08-01
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2009-08-01
HSS	Halter, Head, Traction	Orthopedic	Class 1	888.5890	2009-08-01
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2009-08-01
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2009-08-01

Official Correspondent

Stony Zhang

US Agent Details

Linda Song Email: lindasong06@gmail.com Phone: (972) 5176908

Related Public Records

Same Entity

Leison Medical & Healthcare Products 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
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

Similar Registrations

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3007942528	WELLPOWER SPORTING GOODS CO., LTD.	Dong Guan Guangdong, CN
2183520	Tenacious Holdings Inc	Saint Paul, MN, US
3010239526	Simple Manufacturing DG Ltd	Dongguan City Guangdong, CN
3030683078	HUILING (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.	Xiamen Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007774549. Last updated year: 2026. Please use registration number 3007774549 when referencing this establishment in official correspondence.