Cleared Traditional

K201982 - Air compression therapy system FO-3001 (FDA 510(k) Clearance)

Also includes:
Air compression therapy system FO-3008

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

K201982 · Foshan Hongfeng Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
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Mar 2021
Decision
251d
Days
Class 2
Risk

K201982 is an FDA 510(k) clearance for the Air compression therapy system FO-3001. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Foshan Hongfeng Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on March 25, 2021 after a review of 251 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 Foshan Hongfeng Co., Ltd. devices

Submission Details

510(k) Number K201982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2020
Decision Date March 25, 2021
Days to Decision 251 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
136d slower than avg
Panel avg: 115d · This submission: 251d
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

Shanghai Spica Management Consulting Co., Ltd.
Sam Lin

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

All 149
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K201982.
Air Pressure Therapy System (VU-IPC8M)
K253064 · Xiamen Weiyou Intelligent Technology Co., Ltd. · Apr 2026
Hot and Cold Compression System (A02-C-032)
K252386 · Chengdu Cryo-Push Medical Technology Co.,Ltd · Apr 2026
Cryopush Cold Compression Device (A02-P-001)
K253076 · Chengdu Cryo-Push Medical Technology Co.,Ltd · Apr 2026
Hand Massager (SM004D)
K251622 · Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. · Jan 2026
Air Compression Therapy Device (ST-504)
K251662 · Shenzhen Future Electronic Co., Ltd. · Nov 2025
AIR COMPRESSION BOOTS 1018195,1018196
K251531 · Merchsource, LLC · Oct 2025