Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016591678

FEI Number

3016591678

Entity Name

KAIPENG MEDICAL TECH DEVELOPMENT CO.,LTD

City/State/Country

NingBo Zhejiang, CN

Establishment Address

Middle Gaoyang Road,YinZou, NingBo Zhejiang 315010, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KaiPeng Medical Tech Development co.,Ltd (Owner Number: 10062696)

Owner / Operator Contact Address

No 20,689 Lane,TongPu Road, shanghai, CN-SH 200062, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPLINT, CLAVICLE ORTHOSIS, THORACIC ORTHOSIS, CERVICAL-THORACIC, RIGID JOINT, ANKLE, EXTERNAL BRACE SUPPORT, ARM ORTHOSIS, LUMBAR ORTHOSIS, LUMBO-SACRAL Orthosis, cervical SPLINT, HAND, AND COMPONENTS ORTHOSIS, SACROILIAC, SOFT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2023-11-02
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2023-04-25
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2023-11-02
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2020-03-02
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2023-11-02
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2023-04-25
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2023-04-25
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2023-11-02
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2023-11-02
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2023-11-02

Official Correspondent

Joe Mao

US Agent Details

Sai Chan Business: Rison Email: scchan1997@gmail.com Phone: (949) 2328950

Related Public Records

Same Entity

KaiPeng Medical Tech Development 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-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

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3017633586	Essity Distribution B.V.	GE Oostrum Fryslan, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016591678. Last updated year: 2026. Please use registration number 3016591678 when referencing this establishment in official correspondence.