Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014301546

FEI Number

3014301546

Entity Name

ZHANGZHOU RECARING MEDICAL INSTRUMENT CO., LTD

City/State/Country

Zhangzhou Fujian, CN

Establishment Address

NO. 305, SHANGSHU, Jishan Village, Economic Development Zone, Changtai County,, Zhangzhou Fujian 363900, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZHANGZHOU RECARING MEDICAL INSTRUMENT CO., LTD (Owner Number: 10056807)

Owner / Operator Contact Address

NO. 305, Shangshu, Jishan Village, Economic Development Zone, Changtai County,, Zhangzhou, CN-FJ 363900, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Knee support ASTN ASTN Wrist Barce NO: OTC517 ASTN ASTN ASTN ASTN ASTN ASTN ASTN Walker Boot NO: OTC002 ASTN ASTN ASTN Cervical Collar NO: OTC701 Hinged ROM Knee Brace ASTN NO: OTC215 ASTN Ankle Stirrup Brace NO: OTC109; Ankle night fixator Walking boot; Ankle night fixator ASTN ASTN ASTN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2018-01-18
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2018-01-18
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-01-18
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2020-12-17
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2020-12-17
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2020-12-17
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2018-01-18
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2020-12-17
ITC	Stirrup, External Brace Component	Physical Medicine	Class 1	890.3410	2020-12-17
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2018-01-18
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2020-12-17
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2020-12-15
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2020-12-17
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2018-01-18
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2018-01-18
IOZ	Splint, Abduction, Congenital Hip Dislocation	Physical Medicine	Class 1	890.3665	2020-12-17
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2020-12-17
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2018-01-18

Official Correspondent

Xiaoyue Dai

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 7778490

Related Public Records

Same Entity

ZHANGZHOU RECARING MEDICAL INSTRUMENT 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
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

Registration Number	Establishment Name	Location
3023346034	COMEBETTER (GUANGZHOU) TECHNOLOGY CO., LTD	Guangzhou Guangdong, CN
3029961128	GERO3D LTD	Tel Aviv-Yafo Central, IL
3043047582	OY PRIMO FINLAND AB	Vaasa Pohjanmaa, FI
3018759542	DIMENSION ORTHO Inc.	Philadelphia, PA, US
3009605026	JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.	Yancheng Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014301546. Last updated year: 2026. Please use registration number 3014301546 when referencing this establishment in official correspondence.