Cleared Traditional

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

K213533 · Bio Compression Systems, Inc. · Physical Medicine
Feb 2022
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K213533 is an FDA 510(k) clearance for the Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Bio Compression Systems, Inc. (Moonachie, US). The FDA issued a Cleared decision on February 16, 2022, 103 days after receiving the submission on November 5, 2021. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K213533 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2021
Decision Date February 16, 2022
Days to Decision 103 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