FDA-Device2022-01-26Class II
Heel Snuggler, Reference # 989805603411 99047
Philips North America Llc
Hazard
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Sold states
US Nationwide and Canada.
Affected count
2,509,100 units (Updated to 2,515,200 as of 2/15/22)
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Heel Snuggler, Reference # 989805603411 99047
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0507-2022Don't want to check this manually?
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