Events

Recall of Volt Resistance

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 2k Innovations Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76787
  • Event Risk Class
    Class 2
  • Event Number
    Z-1804-2017
  • Event Initiated Date
    2016-04-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154192
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pad, heating, powered - Product Code IRT
  • Reason
    During an fda inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
  • Action
    2k Innovations sent e-mail communication from 04/15/2016 thru 09/09/2016 informing their consignees that the firm is no longer linking their products to any medical and therapeutic claims and that new labels and boxes will be corrected and the claims will be taken out of the website. For questions customers should call 888-518-6871, ext 700.

Device

Volt Resistance
  • Model / Serial
    Item #VH-SHOULDER
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Volt Resistance Heated Therapy Shoulder Wrap || Deep penetrating heat garment and wraps
  • Manufacturer
    2k Innovations Inc.

Manufacturer

2k Innovations Inc.
  • Manufacturer Address
    2k Innovations Inc., 110 Cumberland Park Dr Ste 205, Saint Augustine FL 32095-8901
  • Manufacturer Parent Company (2017)
    2k Innovations Inc.
  • Source
    USFDA