Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1651499

FEI Number

3002833166

Entity Name

Human Care USA, Inc.

City/State/Country

AUSTIN, TX, US

Establishment Address

8006 Cameron Street, Suite K, AUSTIN, TX 78754, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Human Care HC AB (Owner Number: 9000979)

Owner / Operator Contact Address

Arstaangsvagen 21 B, Stockholm, SE-AB 11743, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Carl-Oskar Fellow Supreme neXus 3 Fellow Classic Rebel Parade neXus oNe Sliding Mat Evacuation Sheet Lifting Mat Raising Aid, Merlin Turning Disc Foot Stool Holding Belt Sliding Mat Wheelchair Open Sliding Mat Caremaster Rollboard, Vision PEM Disposable Sliding Foil Sliding Board Transfer Aid Merlin Raising Aid, Magic Bed Ladder Turning Disc, Soft Slide P87 Rail, all lengths Gate P87 Curves, all Roomer S Raisa Pro EZ Lift 1000 Mobi Pro Flexi P180 Rail, all lengths Back Belt Altair LexaPro FL180 P120 Rail, all lengths HeliQ Turntable Raisa Home Levanto Lena freestand Niklas portable freestand Patient Slings, ALL Alzaro Cosmos Ceiling Lift Mechanical Gate System FlexiRail Freestand Cosmos Accessories i-700 Convertible Chair i-400 Convertible Chair PTS, Patient Transfer System H-250 Convertible Chair Transfer Sheets FloorLine-i Plus FloorLine LTC FloorLine-i

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2001-11-30
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2022-07-28
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2008-01-07
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2019-01-25
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2014-04-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Human Care HC AB

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8043351	HUMAN CARE HC AB	Stockholm, SE
3001708137	HUMAN CARE CANADA INC.	Ottawa Ontario, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

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
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1651499. Last updated year: 2026. Please use registration number 1651499 when referencing this establishment in official correspondence.