Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013564718

FEI Number

3013564718

Entity Name

HEBEI LEAMAI MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Hengshui Hebei, CN

Establishment Address

No. 888 Kaiyuan Road, Jizhou District, Hengshui Hebei 053000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HEBEI LEAMAI MEDICAL INSTRUMENT CO., LTD. (Owner Number: 10092372)

Owner / Operator Contact Address

No. 888 Kaiyuan Road, Jizhou District, Hengshui, CN-HE 053000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Back Brace Support, H55, H56 Neck Traction Device, A01, C01, C02, C03, C05 Medical Fixation Belt, H01, H02, H03

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PMV	Orthosis, Limb, For Back Pain	Physical Medicine	Class 1	890.3475	2024-12-30
IRS	Head Halter, Traction	Physical Medicine	Class 1	890.5925	2024-12-30
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2024-12-30

Official Correspondent

Ke Tian

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

HEBEI LEAMAI MEDICAL INSTRUMENT CO., LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013564718. Last updated year: 2026. Please use registration number 3013564718 when referencing this establishment in official correspondence.