Cleared Traditional

K212935 - Air Pressure Foot Massager

K212935 is an FDA 510(k) clearance for Air Pressure Foot Massager, manufactured by Xiamen Simo Electronic Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K212935 · Xiamen Simo Electronic Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
157d
Days
Class 2
Risk

K212935 is an FDA 510(k) clearance for the Air Pressure Foot Massager. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Xiamen Simo Electronic Co., Ltd. (Xia Men, CN). The FDA issued a Cleared decision on February 19, 2022 after a review of 157 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 Xiamen Simo Electronic Co., Ltd. devices

FDA 510(k) Submission Details - K212935

510(k) Number K212935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2021
Decision Date February 19, 2022
Days to Decision 157 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
42d slower than avg
Panel avg: 115d · This submission: 157d
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

Beijing Believe-Med Technology Service Co., Ltd.
Ray 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 99
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K212935.
Air Compression Therapy Device, model: ST-502
K213745 · Shenzhen Future Electronic Co., Ltd. · Mar 2022
Air Compression Leg Massager (model: FE-7204B)
K211850 · Xiamen Healthpal Electronic Co.,Ltd · Mar 2022
Normatec 3
K220217 · NormaTec Industries, LP · Feb 2022
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. · Feb 2022
Air compression leg massager HY-1117A
K212713 · Xiamen High Top Electronic Technology Co., Ltd. · Jan 2022
Air compression therapy system FO3002
K212169 · Foshan Hongfeng Co., Ltd. · Nov 2021