Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011659673

FEI Number

3011659673

Entity Name

GALEMED LIMITED TAIPEI BRANCH

City/State/Country

Taipei, TW

Establishment Address

5F., No. 209, Sec. 1, Fuxing S. Rd., Taipei 106, Taiwan, Taipei 106, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

GaleMed Corporation (Owner Number: 8043316)

Owner / Operator Contact Address

87, LI-GONG 2ND RD.,, Wu-jia, TW-ILA 268, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EMST150 expiratory muscle device Bravo Trainer, Blue EMST75 Lite Respiratory Trainer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2023-05-13
PKS	Exerciser, Non-Measuring For Stroke Rehabilitation	Physical Medicine	Class 1	890.5370	2023-05-13

Official Correspondent

No official correspondent registered.

US Agent Details

Matt Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076060

Related Public Records

Same Entity

GaleMed Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8043316	GALEMED CORP.	WU-JIA Yilan, TW
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011659673. Last updated year: 2026. Please use registration number 3011659673 when referencing this establishment in official correspondence.