Cleared Traditional

K220161 - Biofeedback Nerve and Muscle Stimulator

K220161 is an FDA 510(k) clearance for Biofeedback Nerve and Muscle Stimulator, manufactured by Shenzhen Konmed Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K220161 · Shenzhen Konmed Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
181d
Days
Class 2
Risk

K220161 is an FDA 510(k) clearance for the Biofeedback Nerve and Muscle Stimulator. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Shenzhen Konmed Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 20, 2022 after a review of 181 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Konmed Technology Co., Ltd. devices

FDA 510(k) Submission Details - K220161

510(k) Number K220161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2022
Decision Date July 20, 2022
Days to Decision 181 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 130d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPI Device Classification - Class 2, Special Controls

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Guangzhou GLOMED Biological Technology Co., Ltd.
Cassie Lee

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 - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 53
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K220161.
MFG-05
K230780 · Zimmer Medizinsysteme GmbH · Oct 2023
Pelvic Floor Muscle Stimulator
K230767 · Nanjing Vishee Medical Technology Co., Ltd. · Sep 2023
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
K222528 · Well-Life Healthcare Limited · Dec 2022
Keffort (MC-100, MC-100A)
K213133 · Oriental Inspiration Limited · Apr 2022
Everyway Incontinence Stimulation System
K213116 · Everyway Medical Instruments Co.,Ltd · Dec 2021
Incontinence Probe
K210441 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Sep 2021