510(k) clearance

Nimbl™ Pneumatic Compression System

FDA 510(k) source

510(k) number

K260586

Applicant

Tactile Medical

Decision date

Oct 27, 2026

Date received

Feb 20, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

JOW

Device type

Sleeve, Limb, Compressible

Device class

Class II

Regulation

21 CFR 870.5800

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Minneapolis, MN, US