# K991478: Tender Touch Silicone Gel Pads

- Pathway: 510(k) (Traditional)
- Applicant: Capital Marketing Technologies, Inc.
- Decided: Jun 21, 1999 after 54 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
TENDER TOUCH™ Silicone Gel Pads are designed to be worn on the body to help reduce pressure and friction against bony prominences, and they can also be used as scar management. This is not a wound covering or dressing and is not sterile.

Source page: https://510kreport.com/device/K991478
Methodology: https://510kreport.com/methodology