SLENDAIR 4000 COMPRESSION SYSTEM— 510(k) K994057

Name: FDA 510(k) clearance K994057
Creator: U.S. Food and Drug Administration
Published: 2000-03-03

Substantially Equivalent

Medical Compression Systems (Dbn) , Ltd.

FDA 510(k) clearance K994057 for SLENDAIR 4000 COMPRESSION SYSTEM, Substantially Equivalent on 2000-03-03. Applicant: Medical Compression Systems (Dbn) , Ltd.. Device class: 2.

Clearance details

Applicant: Medical Compression Systems (Dbn) , Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 1999-11-30
Decision date: 2000-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Ananna 43373, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code IRP

view all

K260944 — ManaCold Compression System2026-08-12
K260529 — Air Compression Massager (HY-1165)2026-07-27
K260948 — Air Compression Massager (EP30B001 I)2026-07-24
K253919 — Cryo And Thermo Therapy System2026-06-10
K252396 — Cryo Sport 2.0 (AVA 501)2026-05-29

More clearances from Medical Compression Systems (Dbn) , Ltd.

view all

K160431 — ActiveCare Home2016-07-13
K140755 — ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS2014-05-08
K113525 — ACTIVECARE DVT ACTIVECARE+SFT2012-01-31
K110159 — ACTIVECARE SFT2011-05-12
K060146 — ACTIVECARE ++ SYSTEM2006-03-08

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