R82 A/S
R82 A/S holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2016, with 4 FDA device recalls on record.
Top product codes for R82 A/S
FDA recalls by R82 A/S
- Z-0569-2022 — R82 by ETAC Push Brace for High-Low
- Z-1858-2020 — Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
- Z-1315-2019 — Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
- Z-0441-2019 — Heron toilet and bath chair Model 880505-01 & 880505-11
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by R82 A/S
Data sourced from openFDA. This site is unofficial and independent of the FDA.