Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010605276

FEI Number

3010605276

Entity Name

APEX HEALTH CARE MFG., INC.

City/State/Country

Min Hsiung Shiang Chiayi, TW

Establishment Address

No. 6, Industrial 2nd Road, Tou Chiao, Industrial Park,, Min Hsiung Shiang Chiayi NA, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

APEX HEALTH CARE MFG.,INC. (Owner Number: 9023057)

Owner / Operator Contact Address

No.6, Industrial 2nd Road, Tou Chiao Industrial Park, Min Hsiung Shiang, Chai Yi Hsien, TW-NOTA --, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

22300 PEDAL EXERCISER W/BLACK FEET APC-220-1 PEDAL EXERCISER CanDo Knee Scooter Sling/Transfer belt Safety pole FloorBed Standard Bed Lever FloorBed 6 Long Bed Lever Assist Bar FloorBed 6 Lifting Pole FloorBed 1 Lifting Pole FloorBed 6 Bed Lever Assist Bar 2940B TRAPEZE STLEV-0-FL1-200 FloorBed Standard Bed Lever Assist Bar AR232 EURO STYLE REACHER 32IN AT440 ASSIST & TURN TRANSFER AID 2800A TRAPEZE 2960B TRAPEZE 2800GA TRAPEZE AR226 EURO STYLE REACHER 26IN 23400 FOREARM CRUTCH W/7/8" SILVER. TAA80535 crutch TAA80534 crutch TAA80536 crutch 23500 EUROPEAN FOREARM CRUTCH 23200ADULT CRUTCHES 23300YOUTH CRUTCHES 23100 TALL ADULT CRUTCHES 22200 OVERDOOR TRACTION UNITS (APC-30305) 22100 EXERCISE PULLEY SETS (APC-30303) 22210 20LB. WATER BAG ONLY (FOR OVERDOOR TRACTION UNITS) 22200 OVERDOOR TRACTION UNITS 13023 Hydraulic Standard Patient Lift 13245 Bariatric Battery Powered Patient Lift with Rechargeable Removable Battery 13244 Bariatric Battery Powered Lift LF1031FP 13240 Bariatric Battery Powered Patient Lift P-C-HLA-2 HOY-ELEVATEWSC LF1031F HOY-ASCEND HOY-STATURE 13242 Bariatric Powered Patient Lift with Rechargeable Removable Battery HOY-ADVANCE-E HOY-PRESENCE HPL402 LF1030F HOY-JOURNEY 13246 Stand-Assist Lift HOY-ELEVATEWSC-S HOY-ELEVATE-S HOY-PRESENCE-S HOY-ELEVATE HOY-CALIBRE-S HOY-JOURNEY-S FS850 FREE SPIRIT 850 PRO BARIATRIC PATIENT LIFT FLP600 Gravis Floor lift, power base, 600 lbs FLNP600 Gravis Floor lift,manual base,600 lbs ECO PATIENT LIFTER FLNP500 Levantar Floor lift,manual base,500 lbs FLP500 Levantar Floor lift, power base, 500 lbs HML-400, C-HLA, C-HLA-2, C-HLA-2T, C-CB-L2, SS-HSP, HOY-ADVANCE-H 146-13245 BARIATRIC ELECTRIC PAITENT LIFT 146-13242 ELECTRIC PATIENT LIFT LF1030 PATIENT LIFT MANUAL, LF1031 PATIENT LIFT MANUAL, LF1031FP PATIENT LIFT MANUAL M-22 MAYO STAND - DOUBLE POLE, M-21 MAYO STAND - SINGLE POLE, oxygen cylinder rack 1834 B Revolving stool 13078 Revolving Pneumatic Adjustable Height Stool with Metal Base 13079 Revolving Pneumatic Adjustable Height Stool with Plastic Base 13032-2 Physical Therapist Stool with Square Padded Seat DS850 SCALE FOR 850LB BARIATRIC PATIENT LIFT APC-22222 Treatment Table APC-22221 Treatment Table APC-22220 Treatment Table APC-22223 Bariatric Treatment Table 29100 OVERBED TABLE TS-150.TS-160.TS-170. TS-175. OVERBED TABLE SERIES 453300 #533 chair 23605 quad cane, small 23606 quad cane, large 23700 ADULT FOLDING ADJUSTABLE WALKING FRAME GF1844W IV POLE WHEELCHAIR TIV-310 Heavy base IV poles w/2 hook, TIV-300 Economy IV poles, IV-40 IV pole 480500: 2 HOOK I.V.POLE w/o base

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	2003-07-31
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2002-12-03
IPR	Crutch	Physical Medicine	Class 1	890.3150	2003-07-31
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2012-12-18
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	1996-04-18
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2003-06-30
PCM	Portable Liquid Oxygen Unit Stand	Physical Medicine	Class 1	890.5050	2014-11-04
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2017-07-24
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2004-04-15
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2023-03-02
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2016-07-28
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2001-08-16
IPS	Cane	Physical Medicine	Class 1	890.3075	2003-07-31
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	1995-10-27

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: REGULATORY INSIGHT, INC. Email: KEVIN@REGINSIGHT.COM Phone: (720) 9625412

Related Public Records

Same Entity

APEX HEALTH CARE MFG.,INC.

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

View Entity Profile →

Related Recall Records

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Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013	Winco Mfg., LLC	1	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010605276. Last updated year: 2026. Please use registration number 3010605276 when referencing this establishment in official correspondence.