Company
Handicare AB
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)
8recalls (0 in 12 months)
0recalls 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) |
|---|---|---|---|
| Aug 21, 2020 | Handicare AB SwiftHook sold as the following:
a. Individually as SwiftHook
b. Included with Vega505EE mobile lifts
Product Usage: The mobile lifts are intended to assist people with functional impairments in scena Terminated |
FSA | None listed |
| Nov 3, 2017 | Handicare Usa Inc Handicare P600 Series Patient Lift
Product Usage:
A device used to lift and transport a patient from one place to another. Terminated |
FNL | None listed |
| Nov 3, 2017 | Handicare Usa Inc Handicare C Series Patient Lift
Product Usage:
A device used to lift and transport a patient from one place to another. Terminated |
FNL | None listed |
| Sep 15, 2017 | Handicare Usa Inc PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered Terminated |
FSA | None listed |
| Jul 28, 2016 | Handicare AB Carina Mobile Lifts, Models:
a) Carina350EM, REF 6060011
b) Carina350EML, REF 60600012
c) Carina350EE, REF 60600009 Terminated |
FSA | None listed |
| Jun 15, 2016 | Handicare AB EVA Floor Lifts, Model Numbers: 400, 450, 600 Open, Classified |
FSA | None listed |
| May 14, 2015 | Handicare USA, Inc. ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid. Terminated |
IKX | None listed |
| Apr 15, 2014 | Handicare USA, Inc. ReTurn 7500/7500
Aid, transfer Terminated |
IKX | None listed |