ClearanceBrief
Company ยท US

Arjo, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2000. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
31recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
FSALift, Patient, Non-Ac-Powered23
FSG4
FNGLift, Patient, Ac-Powered2
FRWScale, Patient2
ILJBath, Hydro-Massage1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 1, 2000K001079RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
Arjo, Inc.
ILJ

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 30, 2009Arjo, Inc.
Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada, J1X 5Y5; model/part numbers ERGOLIFT and ERGOLIFT-2 The equipment is intended to be used in hospitals,
Terminated
FSANone listed
Dec 18, 2008Arjo, Inc.
Arjo Maxi 500 Patient Lift with Manual 4-Point DPS (Dynamic Positioning System) and Scale. A Non-AC-Powered Patient Lift. BHM Medical Inc., Magog, QC, Canada. Model KM560181 and Model KM560081 - Ma
Terminated
FSANone listed
Dec 18, 2008Arjo, Inc.
Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale. A Non-AC-Powered Patient Lift. BHM Medical Inc., Magog, QC, Canada. Model KM560101, and Model KM560001 - Maxi 500 with 2-Point Spread
Terminated
FSANone listed
Dec 16, 2008Arjo, Inc.
Maxi Move, Model NDA0200-20 Batteries Pack; BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada J1X 5Y5 The equipment is intended to be used in hospitals, nursing homes, or other health care facilities
Terminated
FSANone listed
Nov 24, 2008Arjo, Inc.
Arjo Maxi 500 Patient Lift with 4 Point DPS (Dynamic Positioning System) and Scale; a Non-AC-Powered Patient Lift; Models KM560181; BHM Medical Inc., Magog, QC, Canada The Maxi 500 is a mobile passiv
Terminated
FSANone listed
Nov 24, 2008Arjo, Inc.
Arjo Maxi 500 Patient Lift with 2 Point Spreader Bar and Scale; a Non-AC-Powered Patient Lift; Model KM560101; BHM Medical Inc., Magog, QC, Canada The Maxi 500 is a mobile passive lift intended to be
Terminated
FSANone listed
Sep 30, 2008Arjo, Inc.
Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Models KMBB4CLU2FUS, KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NLX2FUS, KMBB4NSX2FUS, K
Terminated
FSANone listed
Sep 20, 2008Arjo, Inc.
Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; The Kwiktrak Gate System consists of part 700.11560 - Kwiktrak gate motor box (serialized), part 700.11550 - Kwi
Terminated
FSANone listed
Aug 28, 2008Arjo, Inc.
Ambulift Classic, battery powered patient lift. The Ambulift is used to move and lift patients from their beds, transport them to the bathroom, and lift them in and out of the bath. Model KDB1890-04U
Terminated
FSANone listed
Aug 28, 2008Arjo, Inc.
Ambulift, standard basic model manually powered patient lift. The Ambulift is used to move and lift patients from their beds, transport them to the bathroom, and lift them in and out of the bath. Mo
Terminated
FSANone listed
Aug 24, 2008Arjo, Inc.
Nautica (GK) Mattress Stretcher, manufactured by Georg Kramer GES.M.B.H. & CO. KG A-4061 PASCH ING, Neuhauserweg 14 Austria. These mattress stretchers were sold for installation on or as a component
Terminated
FSANone listed
Jul 30, 2008Arjo, Inc.
Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients whi
Terminated
FSANone listed
Jul 18, 2008Arjo, Inc.
BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky 600 and BHM V4 Ceiling Patient Lifts; the hand control system is composed of two components,
Terminated
FNGNone listed
Feb 26, 2008Arjo, Inc.
BHM Medical Scales, 1000 lb. scales weight limit; Part Number 700.00525; Manufactured by BHM Medical Inc., Magog, QC, Canada; These scales were sold for installation on the Model V10 and Model Maxisk
Terminated
FRWNone listed
Feb 26, 2008Arjo, Inc.
BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5; These scales were sold for installation on or as a component of th
Terminated
FRWNone listed
Dec 1, 2007Arjo, Inc.
ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden
Terminated
FSANone listed
May 11, 2007Arjo, Inc.
Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OSU2FUS
Terminated
FSGNone listed
May 11, 2007Arjo, Inc.
Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OLU2FUS
Terminated
FSGNone listed
May 11, 2007Arjo, Inc.
Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4MSU2FUS
Terminated
FSGNone listed
May 11, 2007Arjo, Inc.
Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4ELU2FUS
Terminated
FSGNone listed
Feb 15, 2007Arjo, Inc.
Sara Active Sling - Standard; item KK53210.0 - model KA1210 (with safety); manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172
Terminated
FSANone listed
Feb 15, 2007Arjo, Inc.
Sara Active Sling - Wide; item KKX00120.0 - models KA1231 (with safety) and KA1241; manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172
Terminated
FSANone listed
Feb 15, 2007Arjo, Inc.
Sara Active Sling - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240; manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172
Terminated
FSANone listed
Jan 11, 2007Arjo, Inc.
BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog,
Terminated
FSANone listed
Jan 11, 2007Arjo, Inc.
BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5.
Terminated
FSANone listed
Jan 11, 2007Arjo, Inc.
Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model number HMB002-US
Terminated
FNGNone listed
Dec 6, 2006Arjo, Inc.
Sling Rope/Connector Assembly Kits for the Sara Power standing and raising aids; the kit is comprised of 2 x 230 cm ropes, 2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2 spacers;
Terminated
FSANone listed
Dec 6, 2006Arjo, Inc.
Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids; the kit is comprised of 2 x 200 cm ropes, 2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2
Terminated
FSANone listed
Jul 20, 2004Arjo, Inc.
Alenti Lift Hygiene Chair; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers CDB8003-01-US and CDB8053-01-US (with scale)
Terminated
FSANone listed
Jul 20, 2004Arjo, Inc.
Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)
Terminated
FSANone listed
Jul 20, 2004Arjo, Inc.
Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)
Terminated
FSANone listed
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