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Wellair

NOVAERUS (IRELAND) LIMITED · Model Pro XL · UDI-DI 05391532531328

FRF
1
510(k) clearances
31
Adverse events
1
Recalls
11
Facilities

Description

Medical Recirculating Air Cleaner, free standing, AC powered. The device is a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes. Additional trade names: NV1050 and Defend 1050

Recalls

DateFirmReason
2012-01-09Healthway Home Products, Inc.The Company is recalling certain serial numbers of HealthWay Model 20600-3 and CleanStation Model CS20000 air purifiers because of a potential risk of electrical arcing that could

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.