# K013239: Comfortcare Compression Support with Magnets Comfortcare Magnetic Insoles

- Pathway: 510(k) (Traditional)
- Applicant: Med Gen, Inc.
- Decided: Nov 20, 2001 after 53 days
- Product code: FMQ (Restraint, Protective)
- Device class: 1
- Regulation: 21 CFR 880.6760
- 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) Futuro 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
- K040936: Petit Silma Elastic Bandage with Germanium/Titanium Oxide (2004), 0 descendants of its own

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

Source page: https://510kreport.com/device/K013239
Methodology: https://510kreport.com/methodology