Medium RiskFDA Device

2k Innovations Inc.: During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

Agency Publication Date: April 12, 2017

Affected Products

Product: Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps

Item #VH-NECK

Product: Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps

Item #VH-BACK

Product: Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps

Item #VH-SHOULDER

Product: Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps

Item #VH-FOOT

Product: Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps

Item #VH-KNEE

Product: Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps

Item #VH-ELBOW

Product: Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps

Item #GL-7V-FR

Product: Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps

Item #3V-SK

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

Item #VS-BK

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

Item #VS-GR

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

Item #VS-FB

Product: Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps

Item #VS-PU

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76787

Status: Resolved

Manufacturer: 2k Innovations Inc.

Manufactured In: United States

Units Affected: 12 products (22,757 items in total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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