Cleared Traditional

Overlapped Compression Therapy (K202839) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K202839 is an FDA 510(k) clearance for the Overlapped Compression Therapy. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Jkh Health Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 21, 2021 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Jkh Health Co., Ltd. devices

Submission Details

510(k) Number K202839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 91
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K202839.
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