FRFClass II

Cleaner, Air, Medical Recirculating

General Hospital · 21 CFR 880.5045

MDR events31All time

Recalls1All time

Registered firms15Currently listed

510(k) clearances53All time

Recent MDR events

31 adverse event reports on file

Event type breakdown

Malfunction15

Injury12

Unspecified2

Other2

Most-reported manufacturers

Alpine Industries3 Unspecified2 *1 Air Care Uv1 Alpine Air1 Alpine Industries, Inc.1 Austin Air Systems, Inc.1 Bioteck Research1

Recalls

1 recall events for this product code

Healthway Home Products, Inc.
TerminatedJan 31, 2012
Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next to the control panel: HealthWay or CleanStation. HealthWay brand is sol
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 cause overheating or fire within the units.
Z-0933-2012 · View FDA record ↗

Registered firms

15 firms currently registered for this product code

510(k) clearances

53 clearances for this product code