Medical device recalls Moderate risk

2k Innovations Inc. recalls Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps

Recall date
April 15, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1812-2017
FDA classification
Class II
Brand / firm
2k Innovations Inc.
Sold / distributed
Nationwide Distribution

Why it was recalled

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps

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