Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007420694

FEI Number

3007420694

Entity Name

ArjoHuntleigh Polska Sp. zo.o.

City/State/Country

Poznan Wielkopolskie, PL

Establishment Address

Ul. Ks. Wawrzyniaka 2, Komorniki, Poznan Wielkopolskie 62-052, PL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ARJOHUNTLEIGH AB (Owner Number: 8010077)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HYDROVEN GARMENTS (POZNAN - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE) HYDROVEN 3 PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE) HYDROVEN FPR PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE) LIFT WALKER (POZNAN - MFR & COMPLAINTS) CENTURY (POZNAN - MFR, COMPLAINTS) PRIMO (POZNAN - MFR, COMPLAINTS) RHAPSODY (POZNAN - MFR, COMPLAINTS) PRIMO SYSTEM 2000 (POZNAN - MFR, COMPLAINTS) RHAPSODY SYSTEM 2000 (POZNAN - MFR, COMPLAINTS) HARMONY (POZNAN - MFR, COMPLAINTS) PRIMO FERRO (POZNAN - MFR, COMPLAINTS) SYSTEM 2000 (POZNAN - MFR, COMPLAINTS) BUBBLE PAD MATTRESS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ALPHA RESPONSE PUMP (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) NIMBUS 3 PUMP (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) BREEZE MATTRESS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ALPHA TRANCELL DELUXE PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS) ACER PORTABLE LATERAL ROTATION SYSTEM (POZNAN - SPEC.DEVELOPER & POZNAN - COMPLAINTS) BREEZE PUMP (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP SELECT PUMP (SUZHOU - MANUFACTURER & POZNAN - COMPLAINTS) THERAKAIR VISIO MATTRESS (POZNAN - COMPLAINTS) AURA CUSHION (SUZHOU - MFR & POZNAN - COMPLAINTS) FIRST STEP ALL IN ONE (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP SELECT MATTRESSES (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ALPHA RESPONSE MATTRESS (POZNAN - SPEC. DEVELOPER, POZNAN - COMPLAINTS) AUTOLOGIC MATTRESS (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) THERAKAIR VISIO PUMP (POZNAN - COMPLAINTS) NIMBUS 4 PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS) NIMBUS 4 MATTRESS ASSEMBLY RELIANT IS2 (SUZHOU - MFR & POZNAN - COMPLAINTS) PROFICARE (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) AURA PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS) FIRST STEP CIRRUS OVERLAY (SUZHOU - MFR & POZNAN - COMPLAINTS) NIMBUS PRO MATTRESS (SUZHOU - MFR & POZNAN - COMPLAINTS) MAXXAIR ETS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ATMOSAIR 9000AR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) NIMBUS 3 MATTRESS (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) AUTOLOGIC PUMP (SUZHOU - SPEC.DEV & POZNAN - COMPLAINTS) CITADEL CONTROL UNIT AND MATTRESS (SUZHOU - SPEC. DEVELOPER & MANUFACTURER, POZNAN - COMPLAINTS, POZNAN - FOREIGN EXP) ATMOSAIR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP PLUS (SUZHOU - MFR & POZNAN - COMPLAINTS) ATMOSAIR 9000A (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ATMOSAIR APOD (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP SELECT HD (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) AURALIS PUMP (SUZHOU - MFR, POZNAN - MFR & COMPLAINTS) AURALIS MATTRESSES (SUZHOU - MFR, POZNAN - MFR & COMPLAINTS) ATMOSAIR VELARIS MATTRESSES (POZNAN MFR, POZNAN COMPLAINTS) ATMOSAIR VELARIS PUMP (SUZHOU MFR, POZNAN COMPLAINTS) CAYLIS PUMP (SUZHOU MFR, POZNAN COMPLAINTS); CAYLIS MATTRESSES (SUZHOU MFR, POZNAN COMPLAINTS) TRIADYNE PROVENTA (POZNAN - SPEC. DEVELOPER & COMPLAINTS) ROTOPRONE (POZNAN - COMPLAINTS) ROTOREST (POZNAN - SPEC. DEVELOPER & COMPLAINTS) THERAPULSE ATP (SPEC. DEVELOPER & COMPLAINTS) KINAIR MEDSURG (POZNAN - SPEC. DEVELOPER & COMPLAINTS) SKIN IQ 365 (POZNAN - COMPLAINTS) BARIAIR (POZNAN - SPEC. DEVELOPER & COMPLAINTS) CITADEL PATIENT CARE SYSTEM (BED FRAME AND MATTRESS) (POZNAN - MFR & COMPLAINTS) SKIN IQ 1000 (POZNAN - COMPLAINTS) THERAPULSE (POZNAN - SPEC. DEVELOPER & COMPLAINTS) KINAIR IV (POZNAN - SPEC. DEVELOPER & COMPLAINTS) SKIN IQ MCM (POZNAN - COMPLAINTS) Various Arjo Baths (POZNAN FOREIGN EXPORTER) SYMBLISS BATH (POZNAN - MFR & COMPLAINTS) PATIENT HELPER FIXED LIFTING POLE (POZNAN - SPEC DEVELOPER & COMPLAINTS) PATIENT HELPER ROTATING LIFTING POLE (POZNAN - SPEC DEVELOPER & COMPLAINTS) PATIENT HELPER BARIATRIC LIFTING POLE (POZNAN - SPEC DEVELOPER & COMPLAINTS) PATIENT HELPER FULL TRACTION FRAME (POZNAN - SPEC DEVELOPER & COMPLAINTS) FLOWTRON ACS800 PUMP OPERATING ROOM VARIANT (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) FLOWTRON ACS800 PUMP (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) TRI PULSE GARMENTS TRP10, TRP20, TRP30, TRP40 & TRP60L (POZNAN - SPEC. DEV., MFR. & COMPLAINTS) SHOWER PANEL W/SINK (POZNAN - MFR. COMPLAINTS) PRELUDE SHOWER CABINET (POZNAN - SPEC. DEVELOPER & COMPLAINTS) SHOWER PANEL (POZNAN - MFR. COMPLAINTS) FLUSH SINK (POZNAN - MFR, COMPLAINTS, FOREIGN EXPORTER) TORNADO (POZNAN - MFR AND COMPLAINTS) TYPHOON (POZNAN - MFR AND COMPLAINTS) NINJO (POZNAN - MFR AND COMPLAINTS) AMIGO (POZNAN - COMPLAINTS) ENTERPRISE 9000 SERIES (POZNAN - COMPLAINTS) ENTERPRISE 9700X (POZNAN - MFR & COMPLAINTS) MINUET 2 (POZNAN - MFR & COMPLAINTS) BARIMAXX ACTIVE (POZNAN SPEC. DEVELOPER & COMPLAINTS) BARIMAXX II (POZNAN SPEC. DEVELOPER & COMPLAINTS) CONTOURA 1080 (POZNAN - MFR & COMPLAINTS) ENTERPRISE 9600X (POZNAN - MFR & COMPLAINTS) ENTERPRISE 9800X (POZNAN - MFR & COMPLAINTS) CITADEL PLUS BARIATRIC BED FRAME SYSTEM (POZNAN - MFR & COMPLAINTS) CITADEL BED FRAME (POZNAN - MFR & COMPLAINTS) ENTERPRISE 9000X (POZNAN - MFR & COMPLAINTS) EVENDA BED (POZNAN - MFR & COMPLAINTS) ENTERPRISE 5000X (POZNAN - MFR & COMPLAINTS) ENTERPRISE 8000X (POZNAN - MFR & COMPLAINTS) MAXIAIR PUMP (POZNAN - COMPLAINTS ONLY) MAXIAIR TRANSFER MATTRESS (POZNAN - COMPLAINTS ONLY) AIRPAL AIR SUPPLY (POZNAN - MFR, POZNAN - COMPLAINTS) MULTICLEAN (POZNAN - MFR, COMPLAINTS) ATMOSAIR CUSHION (POZNAN - SPEC. DEVELOPER & COMPLAINTS) Hydroven 12 Garments (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS, POZNAN - CONTRACT MFR) Hydroven 12 Pump (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS,SUZHOU- CONTRACT MFR) DISPOSABLE REPOSITIONING SLING (POZNAN - COMPLAINTS) CAREVO (POZNAN - MFR & COMPLAINTS) BOLERO (POZNAN - MFR & COMPLAINTS) SARA 3000 (POZNAN - MFR & COMPLAINTS) MAXI SKY 2 (POZNAN COMPLAINTS ONLY) ALENTI & MIRANTI BELTS/STRAPS (POZNAN - MFR & COMPLAINTS) MIRANTI (POZNAN - MFR & COMPLAINTS) MAXI LITE (POZNAN COMPLAINTS ONLY) MAXI MOVE (POZNAN COMPLAINTS ONLY) VARIOUS STRETCHER SLINGS (POZNAN - COMPLAINTS) MAXI SKY 600 (POZNAN COMPLAINTS ONLY) ACTIVE AND REPOSITIONING SLINGS (POZNAN - COMPLAINTS) CARINO (POZNAN - MFR & COMPLAINTS) ALENTI (POZNAN - MFR & COMPLAINTS) MAXI SKY 1000 (POZNAN COMPLAINTS ONLY) WALKING JACKET (POZNAN COMPLAINTS ONLY) LOOP COMFORT REPOSITIONING SLING (POZNAN - MFR & COMPLAINTS) CONCERTO (POZNAN - MFR & COMPLAINTS) CALYPSO (POZNAN - MFR & COMPLAINTS) MAXI SKY 440 (POZNAN COMPLAINTS ONLY) MAXI 500 (POZNAN COMPLAINTS ONLY) SARA PLUS (POZNAN - MFR & COMPLAINTS) VOYAGER DUO (POZNAN COMPLAINTS ONLY) TENOR (POZNAN - MFR & COMPLAINTS) CARENDO (POZNAN - MFR & COMPLAINTS) VARIOUS STANDING & TRANSFER SLINGS(POZNAN - COMPLAINTS) VOYAGER PORTABLE (POZNAN COMPLAINTS ONLY) MAXI TWIN (POZNAN - MFR & COMPLAINTS) SARA LITE (POZNAN COMPLAINTS ONLY) VARIOUS CLIP & LOOP SLINGS (DISPOSABLE & NON-DISPOSABLE) - (POZNAN - COMPLAINTS) MAXI SKY 2 PLUS (POZNAN COMPLAINTS ONLY) VARIOUS FLITE (DISPOSABLE) 4PT LOOP SLINGS (POZNAN - COMPLAINTS) SARA FLEX (POZNAN COMPLAINTS ONLY) VARIOUS 4PT LOOP (FABRIC) REUSABLE SLINGS (POZNAN - COMPLAINTS) VARIOUS FLITE (DISPOSABLE) 4PT CLIP SLINGS (POZNAN - COMPLAINTS) VARIOUS REPOSITIONING SLINGS (POZNAN - COMPLAINTS) VARIOUS 4PT CLIP (FABRIC) REUSABLE SLINGS (POZNAN - COMPLAINTS) MAXI TWIN COMPACT (POZNAN - MFR & COMPLAINTS) VIPER (POZNAN-MFR & COMPLAINTS) C-HOOK SLING (POZNAN - MFR & COMPLAINTS) MAXI MOVE 5 (POZNAN COMPLAINTS ONLY) LOOP AMBULATION SLING (POZNAN COMPLAINTS ONLY) SYMBLISS BATH CHAIR (POZNAN - MFR & COMPLAINTS) MINSTREL (POZNAN - MFR & COMPLAINTS) SARA STEDY (POZNAN - COMPLAINTS ONLY) SARA STEDY COMPACT (POZNAN - COMPLAINTS ONLY) FLOWTRON ACS900 PUMP OPERATING ROOM (SUZHOU- MFR., POZNAN - COMPLAINTS) FLOWTRON ACS900 PUMP (SUZHOU - MFR., POZNAN - COMPLAINTS) CARINO BED PAN (POZNAN - MFR & COMPLAINTS) ALENTI BED PAN (POZNAN - MFR & COMPLAINTS) CARMINA BED PAN (POZNAN - MFR & COMPLAINTS) CARMINA (POZNAN - MFR & COMPLAINTS) DVT 60L BARIATRIC GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS) FREEDOM BATH (POZNAN - MFR, COMPLAINTS) SEBA LEGLIFT (POZNAN - COMPLAINTS) ARJO PULL STRAPS FOR SLIDE SHEETS (POZNAN - MFR & COMPLAINTS) ARJO SLIDE TUBE (POZNAN - MFR & COMPLAINTS) ARJO SLIDE SHEETS (DISPOSABLE) (POZNAN - MFR & COMPLAINTS) ARJO SLIDE SHEETS (NON-DISPOSABLE) (POZNAN - MFR & COMPLAINTS) ARJO SLIDE FLITES (POZNAN-COMPLAINTS) RIK FOOT HUGGER (POZNAN - SPEC. DEVELOPER & COMPLAINTS) RIK OR PAD (POZNAN - SPEC. DEVELOPER & COMPLAINTS) FLOWTRON EXCEL PUMP (SUZHOU SPEC.DEV, POZNAN - COMPLAINTS) DVT20 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS) L501-M GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS) DVT30 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS) DVT10 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS) DVT40 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS) L503-M GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS) FG200-R LARGE FOOT GARMENT (POZNAN - MFR & COMPLAINTS) FG100-R REGULAR FOOT GARMENT (POZNAN - MFR & COMPLAINTS) FLOWTRON UNIVERSAL AC600 PUMP (POZNAN - COMPLAINTS) FLOWTRON UNIVERSAL AC600OR PUMP (POZNAN - COMPLAINTS) ATMOSAIR 4000 (POZNAN SPEC. DEVELOPER & COMPLAINTS) ATMOSAIR FIT MATTRESS SYSTEM (POZNAN COMPLAINTS) THERAREST SMS (POZNAN MANUFACTURER & COMPLAINTS) RIK OVERLAY (POZNAN SPEC. DEVELOPER & COMPLAINTS) PRESSURE IQ EVOLVE (POZNAN SPEC. DEVELOPER & COMPLAINTS) ATMOSAIR STRETCHER (POZNAN SPEC. DEVELOPER & COMPLAINTS) ATMOSAIR M-SERIES (POZNAN SPEC. DEVELOPER & COMPLAINTS) ATMOSAIR T-SERIES (POZNAN SPEC. DEVELOPER & COMPLAINTS) ATMOSAIR V-SERIES (POZNAN SPEC. DEVELOPER & COMPLAINTS) ATMOSAIR PLUS MATTRESS SYSTEM (POZNAN SPEC. DEVELOPER & COMPLAINTS) ATMOSAIR 9000 (POZNAN SPEC. DEVELOPER & COMPLAINTS) RIK (POZNAN SPEC. DEVELOPER & COMPLAINTS) THERAREST PERIMETER PLUS (POZNAN MANUFACTURER & COMPLAINTS) ATMOSAIR A-SERIES (POZNAN SPEC. DEVELOPER & COMPLAINTS) RIK MATTRESS (POZNAN - SPEC. DEVELOPER & COMPLAINTS) FTS (POZNAN - SPEC. DEVELOPER & COMPLAINTS) SIMULFLEX (POZNAN - MFR, COMPLAINTS, FOREIGN EXPORTER) CONFORMX (POZNAN - MFR, COMPLAINTS, FOREIGN EXPORTER) PENTAFLEX (POZNAN - MFR, COMPLAINTS, FOREIGN EXPORTER) ATMOSAIR 9000X (POZNAN MANUFACTURER & COMPLAINTS) FLUIDAIR ELITE (POZNAN - SPEC. DEVELOPER & COMPLAINTS) FLUIDAIR ( POZNAN - SPEC. DEVELOPER & COMPLAINTS)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-12-05
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2013-10-29
ILJ	Bath, Hydro-Massage	Physical Medicine	Class 2	890.5100	2015-04-21
ILJ	Bath, Hydro-Massage	Physical Medicine	Class 2	890.5100	2015-04-21
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2002-08-15
IKZ	Bed, Patient Rotation, Powered	Physical Medicine	Class 2	890.5225	2003-08-11
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	2003-08-11
ILJ	Bath, Hydro-Massage	Physical Medicine	Class 2	890.5100	2018-08-28
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2015-04-21
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2014-04-30
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2015-04-21
FLH	Washer Of Body Waste Receptacles	General Hospital	Class 1	880.6800	2017-08-10
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2002-08-15
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2015-04-21
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2015-04-21
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2002-08-15
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2016-08-23
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2002-08-15
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2015-04-21
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2015-06-25
FOB	Bedpan	General Hospital	Class 1	880.6730	2013-06-12
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2013-10-29
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-12-05
ILJ	Bath, Hydro-Massage	Physical Medicine	Class 2	890.5100	2015-04-21
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2012-06-14
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2015-04-21
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-12-05
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2009-05-28
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2008-03-04
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2008-03-26
INX	Bed, Air Fluidized	Physical Medicine	Class 2	890.5160	2015-04-22

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
3002806395	ARJOHUNTLEIGH AB	MALMO Skane, SE
9681684	ARJOHUNTLEIGH MAGOG, INC.	MAGOG Quebec, CA
3005619970	Arjo (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
1000589001	HUNTLEIGH HEALTHCARE LTD.	CARDIFF, SOUTH GLAMORGAN, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04
K890935	Dermanetics Corp.	SYSTEM 3000 FLUIDIZED AIR BED	1989-03-15
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007420694. Last updated year: 2026. Please use registration number 3007420694 when referencing this establishment in official correspondence.