# K234155: Nimbl (model PD08-N1)

- Pathway: 510(k) (Traditional)
- Applicant: Tactile Medical
- Decided: Jun 21, 2024 after 175 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K810338 (1981). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143185: entré Model PD08-U, Tactile Systems Technology, Inc. (2015) Summary page 4.

## Indications for use
The Nimbl system is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions: - Chronic edema - Lymphedema - Venous insufficiency - Wound healing

Source page: https://510kreport.com/device/K234155
Methodology: https://510kreport.com/methodology