Data / Medical devices / Poland / ArjoHuntleigh Polska Sp. zo.o.
ArjoHuntleigh Polska Sp. zo.o.: FDA-registered device maker in Poznan Wielkopolskie, Poland, 11 510(k) clearances
ArjoHuntleigh Polska Sp. zo.o. is registered with the FDA (registration 3007420694) in Poznan Wielkopolskie, Poland. It lists 23 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 2, 2018. 11 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007420694
- Address
- Ul. Ks. Wawrzyniaka 2 Komorniki, Poznan Wielkopolskie, Poland, 62-052
- Owner or operator
- ARJOHUNTLEIGH AB (8010077)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- August 15, 2002
- Registered through
- 2026
- Brand names listed
- ACER PORTABLE LATERAL ROTATION SYSTEM (POZNAN - SPEC.DEVELOPER & POZNAN - COMPLAINTS), ACTIVE AND REPOSITIONING SLINGS (POZNAN - COMPLAINTS), AIRPAL AIR SUPPLY (POZNAN - MFR, POZNAN - COMPLAINTS), ALENTI & MIRANTI BELTS/STRAPS (POZNAN - MFR & COMPLAINTS), ALENTI (POZNAN - MFR & COMPLAINTS), ALENTI BED PAN (POZNAN - MFR & COMPLAINTS), ALPHA RESPONSE MATTRESS (POZNAN - SPEC. DEVELOPER, POZNAN - COMPLAINTS), ALPHA RESPONSE PUMP (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Hygiene | ILS | 1 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Aid, Transfer | IKX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Apparatus, Traction, Non-Powered | HST | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bath, Hydro-Massage | ILJ | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bed, Ac-Powered Adjustable Hospital | FNL | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bed, Air Fluidized | INX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bed, Flotation Therapy, Powered | IOQ | 2 | Complaint file establishment | accessdata.fda.gov |
| Bed, Patient Rotation, Powered | IKZ | 2 | Complaint file establishment | accessdata.fda.gov |
| Bedpan | FOB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Chair, Adjustable, Mechanical | INN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Chair, With Casters | INM | 1 | Complaint file establishment | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Complaint file establishment | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Complaint file establishment | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Stretcher, Wheeled | FPO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Table, Powered | INQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Washer Of Body Waste Receptacles | FLH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 2, 2018 | K172103 | Flowtron DVT5 Small Calf Garment | JOW | Substantially Equivalent | Getinge (Suzhou) Co., Ltd. | accessdata.fda.gov |
| June 23, 2015 | K143438 | Flowtron ACS900 | JOW | Substantially Equivalent | Getinge (Suzhou) Co., Ltd. | accessdata.fda.gov |
| February 28, 2014 | K133119 | FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS | JOW | Substantially Equivalent | Arjohuntleigh Polska SP Z.O.O. | accessdata.fda.gov |
| July 6, 2011 | K110994 | PARKER 500 | ILJ | Substantially Equivalent | Arjohuntleigh, Inc. | accessdata.fda.gov |
| September 19, 2002 | K022786 | DVT60 | JOW | Substantially Equivalent | Huntleigh Healthcare, Inc. | accessdata.fda.gov |
| March 26, 2002 | K010744 | FLOWTRON UNIVERSAL, MODEL AC600 | JOW | Substantially Equivalent | Huntleigh Healthcare, Inc. | accessdata.fda.gov |
| May 1, 2000 | K001079 | RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO | ILJ | Substantially Equivalent | Arjo, Inc. | accessdata.fda.gov |
| January 26, 1998 | K965153 | HUNTLEIGH FP5000 SYSTEM MODEL FP5000 | JOW | Substantially Equivalent | Huntleigh Healthcare, Inc. | accessdata.fda.gov |
| October 11, 1996 | K961166 | FLOWTRON EXCEL PUMP | JOW | Substantially Equivalent | Hne Healthcare, Inc. | accessdata.fda.gov |
| November 2, 1995 | K952442 | FREEDOM BATH | ILJ | Substantially Equivalent | Grand Traverse Technologies | accessdata.fda.gov |
| August 28, 1995 | K930665 | CENTURY BATHING SYSTEM | ILJ | Substantially Equivalent | Arjo-Century, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 25, 2026 | 99900 | Not yet classified | Open, Classified | Carevo, Height-adjustable shower trolley, Model Number BAC1111-01 | The side support of the shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling. If the side support is not fully locked and an additional force is applied by the caregiver on the handle (e.g., during turning or repositioning), the panel may open unintentionally, which can lead to | accessdata.fda.gov |
| March 10, 2026 | 98542 | Class II | Ongoing | Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US | An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm. | accessdata.fda.gov |
| August 29, 2023 | 93463 | Class II | Ongoing | Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules | Unintended movement of bed wheels | accessdata.fda.gov |
| April 5, 2022 | 89960 | Class I | Terminated | Sara Plus Active Floor Lift | The device may emit smoke or ignite. | accessdata.fda.gov |
| June 10, 2021 | 88469 | Class II | Terminated | Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (mode | The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks. | accessdata.fda.gov |
| July 21, 2020 | 86065 | Class II | Terminated | Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment. | Modular Junction Box (MJB) cables can melt and affect the bed functionality. | accessdata.fda.gov |
| August 22, 2019 | 84881 | Class II | Terminated | Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [(01)05055982796156], | The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (break in one of the arms of safety catch), which in certain circumstances may contribute to the side support unintentionally opening and may lead to a potential risk of a patient fall. The patient falling could lead to various types of injuries. | accessdata.fda.gov |
| October 22, 2018 | 81562 | Class II | Terminated | ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designed to be used for one | Inspection process at the manufacturer found nonwoven material was used in specific lots of product that may break wile in use during the patient/resident transfer. Patient/resident might fall on the floor. IN consequence, the patient might sustain a major trauma, head injury - damage to tissue that is irreversible or may lead to death. | accessdata.fda.gov |
| June 29, 2016 | 74506 | Class II | Terminated | ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients. | ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer lifting mechanism, providing a potential for risk to the patient or the caregiver. The tipping phenomenon has been found during internal device testing. To date, there have been no adverse events or customer complaints related to the tipping phenomenon. The tipp | accessdata.fda.gov |
| July 28, 2014 | 68594 | Class II | Terminated | Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel | ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. There is a remote risk concerning the bolt unscrewing from the scale. When the scale and bolt parts are not correctly serviced, or when they receive a sharp blow during or outside of use, it is possible the bolt holding the spreader bar to the scale could unscrew du | accessdata.fda.gov |
| June 10, 2014 | 68113 | Class II | Terminated | Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's r | ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke during use. There is a remote risk concerning the breakage of the spreader bar bolt connection, part # TEN.018. During use, the bolt is subjected to mechanical forces, which may lead to breakage. | accessdata.fda.gov |
Compare with other makers
- All makers of Protector, Skin Pressure
- All makers of Bath, Hydro-Massage
- All makers of Bed, Patient Rotation, Powered
- All makers of Sleeve, Limb, Compressible
- All makers of Disinfectant, Medical Devices
- All makers of Apparatus, Traction, Non-Powered
Updated October 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.