Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012292104

FEI Number

3012292104

Entity Name

Arjo Dominican Republic

City/State/Country

Itabo, Haina San Cristobal, DO

Establishment Address

Building 9 PIISA Industrial Park, Km. 18 1/2 Antigua Carretera Sanchez, Itabo, Haina San Cristobal 10903, DO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ArjoHuntleigh AB (Owner Number: 10051620)

Owner / Operator Contact Address

Hans Michelsensgatan 10, Malmo, SE-M 211 20, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K961166

PMA Number

N/A

All Registered Proprietary Names

ACTIVE AND REPOSITIONING SLINGS VARIOUS FLITE (DISPOSABLE) 4PT CLIP SLINGS DISPOSABLE REPOSITIONING SLING VARIOUS FLITE (DISPOSABLE) 4PT LOOP SLINGS VARIOUS CLIP & LOOP SLINGS (DISPOSABLE & NON-DISPOSABLE) VARIOUS 4PT LOOP (FABRIC) REUSABLE SLINGS VARIOUS REPOSITIONING SLINGS VARIOUS STRETCHER SLINGS VARIOUS STANDING & TRANSFER SLINGS VARIOUS 4PT CLIP (FABRIC) REUSABLE SLINGS LOOP AMBULATION SLING Arjo Disposable Slide Tube Arjo Disposable Slide sheets SKIN IQ 1000 SKIN IQ 365 SKIN IQ MCM DVT40 DVT30

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2016-04-12
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2019-10-31
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	2016-04-12
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2019-03-21

Official Correspondent

No official correspondent registered.

US Agent Details

Darren Demerritt Business: Arjo Inc Email: darren.demerritt@arjo.com Phone: (425) 3089587

Related Public Records

Same Entity

ArjoHuntleigh 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
3007518069	ARJOHUNTLEIGH LOGISTICS	Eindhoven Noord-Brabant, NL
3010010434	Arjo Canada Inc.	Mississauga Ontario, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K890935	Dermanetics Corp.	SYSTEM 3000 FLUIDIZED AIR BED	1989-03-15
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

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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3004648937	Winncare Nordic ApS	KORSOR Sjalland, DK
3013528441	Green Source Technology (Hebei) Inc.	Langfang City Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012292104. Last updated year: 2026. Please use registration number 3012292104 when referencing this establishment in official correspondence.