# K040054: Back in Action Compression & Support with Magnets for the Lower Back, Knee and Ankle

- Pathway: 510(k) (Traditional)
- Applicant: Theodore Barash
- Decided: Apr 27, 2004 after 106 days
- Product code: FQM (Bandage, Elastic)
- Device class: 1
- Regulation: 21 CFR 880.5075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013244 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013244: Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare Magnetic Insoles and Aegis Microbe, Med Gen, Inc. (2001) Summary page 3.

## Indications for use
For relief of minor physical discomforts incurred by acute trauma, repetitive stress and overuse injuries associated with first degree sprains of overstretched ligaments and first degree strain injuries to tendons. The device compresses, supports and protects vulnerable body parts from post-injury impact incurred by repetitive stress and overexertion self-limiting physical injuries.

Source page: https://510kreport.com/device/K040054
Methodology: https://510kreport.com/methodology