# K061242: Dermatherapy, Model 22216

- Pathway: 510(k) (Traditional)
- Applicant: Precision Fabrics Group, Inc.
- Decided: Jan 25, 2007 after 267 days
- Product code: FMW (Cover, Mattress (Medical Purposes))
- Device class: 1
- Regulation: 21 CFR 880.6190
- 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 K903382 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903382: Allergy Control Covers, Allergy Control Products, Inc. (1990) Summary page 1.

## Most influential descendants
- K152884: DermaTherapy Bed Linens (2016), 0 descendants of its own

## Indications for use
Institutional Bedding (bed sheets and pillow cases) made with DermaTherapy TM fabrics is intended for use by patients in a hospital, healthcare or home setting who are susceptible to or may have mild atopic dermatitis.

Source page: https://510kreport.com/device/K061242
Methodology: https://510kreport.com/methodology