Joerns Healthcare

FDA Device Registration & Listing · Arlington, TX, US · Registration 3009402404

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009402404
FEI Number
3009402404
Entity Name
Joerns Healthcare
City/State/Country
Arlington, TX, US
Establishment Address
2100 Design Rd, Arlington, TX 76014, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
JOERNS HEALTHCARE LLC (Owner Number: 9105099)
Owner / Operator Contact Address
2100 Design Road, --, Arlington, TX 76014, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DermaFloat LAL Arise LAL Cair APM Arise 1000EX ProCair Plus Cair LAL Alternate Cair Plus TxCair Plus DermaFloat APL Dolphin Fluid Immersion System DermaFloat APM FlapCair CairTurn P.R.O. Matt Plus Cair 1000 LAL WeCare Response Bed RC 1000 Bed RC 750 Bed RCUltra Hi-Lo 850 Bed Bari10A Bed Foam Headcradles Foam Arm/Elbow/Ulnar Protectors Foam Headcradles Foam Bolsters/Extenders, Siderails Foam Heel/Ankle/Foot protectors Foam Abduction Pillows Foam Arm/Elbow/Ulnar Protectors Foam Pillows Foam Wedges/Aligners Foam Donuts HOYER JOURNEY HOYER STATURE HOYER ELARA4-625 Sling Easy-fit Hoyer Switch Sling Dress Toileting Sling Comfort HOYER ELARA2-625 HOYER CALIBRE Hoyer Sling HOYER ADVANCE-H Sling Transfer Sling Stand Assist HOYER ASCEND C-HLA-2T HML400 Hoyer Up 440 Sling Cradle HOYER PRESENCE HOYER ELARA4-500 HOYER ADVANCE-E Sling Universal HOYER ELARA2-500 HPL500 HOYER ELEVATE SS-HSP HPL700 HPL402 C-HLA HOYER VOYAGER C-CB-L2 HPL 450-EL Full Back Sling QuickFit Sling Access Sling HML450 Bariatric Full Back Sling Seat/Back Sling Longseat Sling Deluxe Transport Sling HPL 450-ML QuickFit Deluxe Sling One Piece Commode Sling Comfort Amputee Sling Deluxe Stand Aid Sling Sliding Sheet One Piece Sling

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FNM Mattress, Air Flotation, Alternating Pressure General Hospital Class 2 880.5550 1997-09-16
FNJ Bed, Manual General Hospital Class 1 880.5120 1992-11-17
OSI Bariatric Bed General Hospital Class 2 880.5100 2018-01-25
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2002-07-02
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 1992-12-14
FSA Lift, Patient, Non-Ac-Powered General Hospital Class 1 880.5510 1996-08-29

Official Correspondent

Rick Willis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

JOERNS HEALTHCARE LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018084435 Joerns Healthcare Brownsville Brownsville, TX, US
3012392312 Joerns Healthcare Charlotte, NC, US
3009525805 Joerns Healthcare Matamoros H. Matamoros, Tamaulipas Mexico, MX

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2018 Handicare Usa Inc 1
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018 Handicare AB Maskinvagen 1
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009402404. Last updated year: 2026. Please use registration number 3009402404 when referencing this establishment in official correspondence.
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