Nimbl Pneumatic Compression System— 510(k) K260586

Name: FDA 510(k) clearance K260586
Creator: U.S. Food and Drug Administration
Published: 2026-10-27

Substantially Equivalent

Tactile Medical

FDA 510(k) clearance K260586 for Nimbl Pneumatic Compression System, Substantially Equivalent on 2026-10-27. Applicant: Tactile Medical. Device class: 2.

Clearance details

Applicant: Tactile Medical
Product code: Product code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2026-02-20
Decision date: 2026-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOW

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K261807 — Sequential Circulator (SC-4004-DL, SC-4008-DL)2026-09-11
K254217 — Aerloom2026-08-31
K253555 — Flexitouch® Plus Advanced Pneumatic Compression System2026-07-31
K253386 — DVT Garment2026-06-25
K250242 — Compression Therapy Device (LGT-2202DVT)2026-04-24

More clearances from Tactile Medical

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K252849 — AffloVest® Mobile Airway Clearance Therapy2026-04-30
K234155 — Nimbl (model PD08-N1)2024-06-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.