Cleared Traditional

YY-A02-B Overlapped Compression Therapy (K221862) - FDA 510(k) Clearance

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

K221862 · Huizhou Xinyi Technology Co., Ltd. · Physical Medicine device
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Dec 2022
Decision
164d
Days
Class 2
Risk

K221862 is an FDA 510(k) clearance for the YY-A02-B Overlapped Compression Therapy. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Huizhou Xinyi Technology Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on December 8, 2022 after a review of 164 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 Huizhou Xinyi Technology Co., Ltd. devices

Submission Details

510(k) Number K221862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2022
Decision Date December 08, 2022
Days to Decision 164 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 115d · This submission: 164d
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 Peers - IRP Massager, Powered Inflatable Tube

All 95
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