Cleared Traditional

Overlapped Compression Therapy

K202839 · Jkh Health Co., Ltd. · Cardiovascular
Jan 2021
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K202839 is an FDA 510(k) clearance for the Overlapped Compression Therapy, 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 January 21, 2021, 118 days after receiving the submission on September 25, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K202839 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2020
Decision Date January 21, 2021
Days to Decision 118 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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

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