Cleared Traditional

AIR COMPRESSION BOOTS 1018195,1018196

K251531 · Merchsource, LLC · Physical Medicine
Oct 2025
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K251531 is an FDA 510(k) clearance for the AIR COMPRESSION BOOTS 1018195,1018196, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Merchsource, LLC (Irvine, US). The FDA issued a Cleared decision on October 30, 2025, 164 days after receiving the submission on May 19, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K251531 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2025
Decision Date October 30, 2025
Days to Decision 164 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IRP — Massager, Powered Inflatable Tube
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5650

Similar Devices — IRP Massager, Powered Inflatable Tube

All 146
Hand Massager (SM004D)
K251622 · Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. · Jan 2026
Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507)
K251662 · Shenzhen Future Electronic Co., Ltd. · Nov 2025
Cryon-X Cold Compression
K253150 · Jkh Health Co., Ltd. · Oct 2025
Normatec Elite Hip
K251905 · NormaTec Industries, LP · Sep 2025
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)
K251623 · Shenzhen Yicai Health Technology Co., Ltd. · Sep 2025
Compression Therapy Device (LGT-2210DS)
K250244 · Guangzhou Longest Medical Technology Co., Ltd. · Jul 2025