Etac Supply Center AB
Anderstorp Jonkoping, SE
ETAC SUPPLY CENTER AB appears in FDA device records in Anderstorp Jonkoping, SE. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
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 |
|---|---|---|---|---|---|
| 3008986539 | 3008986539 | ETAC SUPPLY CENTER AB | Langgatan 12, Anderstorp Jonkoping 334 33 SE | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNOAccessories, Wheelchair
- ILDAdaptor, Dressing
- ILWAdaptor, Grooming
- ILSAdaptor, Hygiene
- IKXAid, Transfer
- IMLArmrest, Wheelchair
- IQBBelt, Wheelchair
- IMWBrake, Extension, Wheelchair
- INNChair, Adjustable, Mechanical
- INMChair, With Casters
- IMPCushion, Wheelchair
- IMRDevice, Anti-Tip, Wheelchair
- IMMFootrest, Wheelchair
- IMOHandrim, Wheelchair
- IMZHolder, Crutch And Cane, Wheelchair
- IMSSupport, Head And Trunk, Wheelchair
- ILCUtensil, Eating
- IKWUtensil, Homemaking
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2381-2015 | Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use. | The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat where the wall bracket has cracked or broken. | Class II | Terminated | |
| Z-2073-2015 | Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid. | The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The firm has reports of the two Fast Nuts coming loose and causing the Supporter to become unsteady. | Class II | Terminated | |
| Z-1807-2013 | Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights. | Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Swift Mobil shower chair loses a caster and thus becomes instantly unstable, there is potiential risk for harm or injury. | Class II | Terminated | |
| Z-2014-2012 | Etac Ono Walker, Etac Avant Walker, and Etac Salsa Walker. These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG. | The recall has been initiated because there is the potential that users may fall and become injured, with the potential for serious injury, including bone fracture. One death occurred in a user fall incident, but it is unclear whether the fall was caused by the loss of a wheel. Among the walkers distributed worldwide, Etac has received a total of 49 reports from Europe and Japan of wheels falling | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain