FDA-Device2017-04-19Class II
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
2k Innovations Inc.
Hazard
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Sold states
Nationwide Distribution
Affected count
22,757 items in total
Manufactured in
110 Cumberland Park Dr Ste 205, N/A, Saint Augustine, FL, United States
Products
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1804-2017Don't want to check this manually?
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