Cleared Traditional

K201694 - Air Compression Therapy Device

K201694 is the FDA 510(k) clearance for Air Compression Therapy Device by Shenzhen Dongjilian Electronics Co., Ltd.. It is a Class 2 Physical Medicine device (product code IRP) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K201694 · Shenzhen Dongjilian Electronics Co., Ltd. · Physical Medicine device
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Nov 2020
Decision
150d
Days
Class 2
Risk

K201694 is an FDA 510(k) clearance for the Air Compression Therapy Device. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Shenzhen Dongjilian Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 19, 2020 after a review of 150 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine device 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Dongjilian Electronics Co., Ltd. devices

Submission Details

510(k) Number K201694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2020
Decision Date November 19, 2020
Days to Decision 150 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 115d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 Physical Medicine devices follow this clearance model.

Regulatory Consultant

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Reanny Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

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