# K970721: Dyna-Flex Multi-Layer Compression System

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Mar 21, 1997 after 22 days
- Product code: MCY (Wound Dressing Kit)
- Device class: 2
- 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.
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 its predicate without a number.
- (no number) Wound Care Compression System (WCCS): named in the summary without a submission number

## Indications for use
DYNA-FLEX* Multi-Layer Compression System is indicated for the management of venous leg ulcers and related conditions. The compression system may be used on patients with an ankle circumference of 18 cm or larger (padded). Compression data indicates that the DYNA-FLEX* Multi-Layer Compression System provides sustained compression for up to seven days at both the ankle and below the knee, when used according to package insert directions. The DYNA-FLEX Multi-Layer Compression System should not be used on diabetic patients with advanced small vessel disease, patients with lymphadema as a result of cancer, or on patients with an ankle:brachial index (ABI) of less than 0.8 . Doppler ultrasound is recommended to rule out arterial disease.

Source page: https://510kreport.com/device/K970721
Methodology: https://510kreport.com/methodology