FDA Medical Device Recalls (openFDA)
2k Innovations Inc.: Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
- Recall number
- Z-1807-2017
- Recalling firm
- 2k Innovations Inc.
- Product
- Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
- Status
- Terminated
- Initiated
- 2016-04-15
- Posted
- not on file
- Terminated
- 2019-08-07
- Reason
- During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- Root cause
- Labeling False and Misleading
- 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.
- Quantity
- 22,757 items in total
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Item #VH-ELBOW
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IRT
- Firm FEI
- 3010476958
- Firm city
- Saint Augustine
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28