# K013244: Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare Magnetic Insoles and Aegis Microbe

- Pathway: 510(k) (Traditional)
- Applicant: Med Gen, Inc.
- Decided: Dec 7, 2001 after 70 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton-Dickinson compression support products: named in the summary without a submission number
- (no number) Ace compression support products: named in the summary without a submission number
- (no number) Homedics products with magnets: named in the summary without a submission number
- (no number) Nikken products with magnets: named in the summary without a submission number

## Most influential descendants
- K040054: Back in Action Compression & Support with Magnets for the Lower Back, Knee and Ankle (2004), 0 descendants of its own

## Indications for use
ComfortCare Compression Support with Magnets & Anti-Bacterial Agent is designed to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive actions assoociated with athletic, workplace and at-home activities. Device provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injurics. ComfortCare Absortek fabric construction provides for absorption and venting of perspiration from targeted areas, minimizing potential for skin irritation. ComfortCare Magnetic Insoles with Anti-Bacterial Agent provide foot comfort while layered absorptive fabric vents moisture from feet, minimizing damp environment conducive to breeding bacterial and fungal growth.

Source page: https://510kreport.com/device/K013244
Methodology: https://510kreport.com/methodology