Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016832824

FEI Number

3016832824

Entity Name

Leader Garment Co., Ltd.

City/State/Country

Long Ho District Vinh Long, VN

Establishment Address

Lot II-7, Hoa Phu Industrial Park (phase 2), Phuoc Hoa Hamlet, Phu Quoi Commune, Vinh Long Province, Long Ho District Vinh Long 890000, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MAKALOT INDUSTRIAL CO., LTD (Owner Number: 10068735)

Owner / Operator Contact Address

2F., No.550, Sec. 4, Zhongxiao E. Rd., Xinyi Dist.,, Taipei City 110, Taiwan (R.O.C.), Taipei City, TW-TPE 110, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Katalyst Training System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-02-28

Official Correspondent

Tsung Fu Wu

US Agent Details

David Lee Business: Dynamic Biotech, Inc. Email: davidlee@ivddreg.com Phone: (949) 2180929

Related Public Records

Same Entity

MAKALOT INDUSTRIAL 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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016832824. Last updated year: 2026. Please use registration number 3016832824 when referencing this establishment in official correspondence.