Cleared Traditional

2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM

K122112 · Bio Compression Systems, Inc. · Physical Medicine
Apr 2013
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K122112 is an FDA 510(k) clearance for the 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Bio Compression Systems, Inc. (Toms River, US). The FDA issued a Cleared decision on April 9, 2013, 266 days after receiving the submission on July 17, 2012. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K122112 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2012
Decision Date April 09, 2013
Days to Decision 266 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
AIR COMPRESSION BOOTS 1018195,1018196
K251531 · Merchsource, LLC · Oct 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