Cleared Traditional

K221862 - YY-A02-B Overlapped Compression Therapy

K221862 is an FDA 510(k) clearance for YY-A02-B Overlapped Compression Therapy, manufactured by Huizhou Xinyi Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 164-day FDA review.

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

FDA 510(k) Submission Details - K221862

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.

IRP Device Classification - Class 2, Special Controls

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 98
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K221862.
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