Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018013882

FEI Number

3018013882

Entity Name

ARKIETECH ENGINEERING CO.,

City/State/Country

Tainan City, TW

Establishment Address

58-28, Xin-Ji Village,Anding Dist.,, Tainan City 745, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Arkietech Engineering Co., (Owner Number: 10084425)

Owner / Operator Contact Address

58-28, Xin-Ji Village,Anding Dist.,, Tainan City, TW-TNN 745, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Halo Safety Wing with ALC bracket system for traditional bed (twin to queen) with metal L-frame Halo Safety Ring with hospital bed bracket system Halo Safety Ring with ALC bracket system for traditional bed (twin to queen) with metal L-frame Halo Safety Wing with hospital bed bracket system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2022-03-03

Official Correspondent

YU-LING SU

US Agent Details

Rachel Kunde Email: rkunde@halomobilitysolutions.com Phone: (347) 7075712

Related Public Records

Same Entity

Arkietech Engineering Co.,

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 3018013882. Last updated year: 2026. Please use registration number 3018013882 when referencing this establishment in official correspondence.