Company
Arjo, Inc. dba ArjoHuntleigh
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2017 | Arjo, Inc. dba ArjoHuntleigh ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099
Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribe Terminated |
JOW | K143438 |
| Dec 21, 2015 | Arjo, Inc. dba ArjoHuntleigh The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nu Terminated |
FSA | None listed |
| Oct 17, 2014 | Arjo, Inc. dba ArjoHuntleigh Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425.
Intended to be used for general transfers in hospitals. Terminated |
FSA | None listed |
| Aug 6, 2013 | Arjo, Inc. dba ArjoHuntleigh Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9 Terminated |
FNL | None listed |
| Aug 6, 2013 | Arjo, Inc. dba ArjoHuntleigh Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800
General medicine, general and specialist surgery, Terminated |
FNL | None listed |
| Dec 27, 2012 | Arjo, Inc. dba ArjoHuntleigh Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence Terminated |
JOW | K010744 |
| Jul 6, 2012 | Arjo, Inc. dba ArjoHuntleigh Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US.
The Sara Plus is a standing and rais Terminated |
FSA | None listed |
| Jul 6, 2012 | Arjo, Inc. dba ArjoHuntleigh Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US.
The Chorus is designed to be use Terminated |
FSA | None listed |
| Jul 6, 2012 | Arjo, Inc. dba ArjoHuntleigh Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US.
The Encore is designed to be used as a standin Terminated |
FSA | None listed |
| Aug 24, 2011 | Arjo, Inc. dba ArjoHuntleigh Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a swimming/therapy pool; Arjo Hospital Equipment AB, Eslov, Sweden; Models GAB1000-01-xx, GAB1000 Terminated |
FSA | None listed |
| Apr 14, 2011 | Arjo, Inc. dba ArjoHuntleigh Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; ArjoHuntleigh, Addison, IL 60101; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 912 Terminated |
FSA | None listed |
| Apr 11, 2011 | Arjo, Inc. dba ArjoHuntleigh Rolko Adjustable (retractable) Strap and Handle, type TGN-R100GR; a component of a Lifting Pole, an accessory to long term care hospital beds such as ArjoHuntleigh's Minuet 2 Community bed and Enterpr Terminated |
FNK | None listed |