# K040936: Petit Silma Elastic Bandage with Germanium/Titanium Oxide

- Pathway: 510(k) (Traditional)
- Applicant: Leda Co., Ltd.
- Decided: May 3, 2004 after 24 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 K013239 (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)
- K013239: Comfortcare Compression Support with Magnets Comfortcare Magnetic Insoles, Med Gen, Inc. (2001) Summary page 1.

## Indications for use
The Petit Silma Elastic Bandage with Germanium/Titanium Oxide is designed to provide relief of minor physicial discomforts that have their origin in stress and strain of repetitive actions associated with athletic, workplace and at-home activities. The device provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injuries.

Source page: https://510kreport.com/device/K040936
Methodology: https://510kreport.com/methodology