Direct Healthcare Group Sverige AB
Reftele Jonkoping, SE
Direct Healthcare Group Sverige AB appears in FDA device records in Reftele Jonkoping, SE. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Direct Healthcare Group Sverige AB carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Handicare ABenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009107702 | 3009107702 | Direct Healthcare Group Sverige AB | Industrigatan 2, Reftele Jonkoping 33375 SE | 2026 | |
| 3009481053 | 3009481053 | Direct Healthcare Group Sverige AB | Torshamnsgatan 35, Kista Stockholm 164 40 SE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0096-2021 | 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 scenarios involving physical positioning. | Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component. | Class II | Terminated | |
| Z-0014-2018 | Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009 | A limited amount of Carina mobile lifts have been delivered with a too small locking pin. If a locking pin smaller than the correct size is mounted on the Carina mobile lift, the locking pin is likely to cause increased wear on the plastic bushings. In case of continued use, these components may cause wear on the metal of the piston rod eye. | Class II | Terminated | |
| Z-1943-2020 | EVA Floor Lifts, Model Numbers: 400, 450, 600 | After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if the joint breaks. All lifts must therefore be checked and reported back to the manuafacturer. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain