Cleared Traditional

K262812 - Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)

K262812 is an FDA 510(k) clearance for Air compression massager (ACM-C1, manufactured by Sichuan Qianli-Beoka Medical Technology, Inc.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K262812 · Sichuan Qianli-Beoka Medical Technology, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
59d
Days
Class 2
Risk

K262812 is an FDA 510(k) clearance for the Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM.... Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Sichuan Qianli-Beoka Medical Technology, Inc. (Chengdu, CN). The FDA issued a Cleared decision on October 5, 2026 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262812

510(k) Number K262812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2026
Decision Date October 05, 2026
Days to Decision 59 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
57d faster than avg
Panel avg: 116d · This submission: 59d
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 Consultant

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Reanny Wang

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 157
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K262812.
Normatec Elite Heat (PRO26-SH)
K261887 · NormaTec Industries, LP · Oct 2026
ManaCold Compression System
K260944 · Manamed, LLC · Aug 2026
Air Compression Massager (HY-1165)
K260529 · Xiamen High Top Electronic Technology Co., Ltd. · Jul 2026
Air Compression Massager (EP30B001 I)
K260948 · Wavepulse (Xiamen) Healthcare Technology Co., Ltd. · Jul 2026
Cryo And Thermo Therapy System
K253919 · Xiamen Weiyou Intelligent Technology Co., Ltd. · Jun 2026
Cryo Sport 2.0 (AVA 501)
K252396 · Avanutri Equipamentos DE Saúde · May 2026
K262812 · Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)
Download PDF FDA Summary Sichuan Qianli-Beoka …