Cleared Traditional

Lymphedema Compression

K240011 · Jkh Health Co., Ltd. · Cardiovascular
Feb 2024
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K240011 is an FDA 510(k) clearance for the Lymphedema Compression, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Jkh Health Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 23, 2024, 52 days after receiving the submission on January 2, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K240011 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2024
Decision Date February 23, 2024
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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