Cleared Traditional

K163094 - TinniLogic Mobile Tinnitus Management Device

K163094 is an FDA 510(k) clearance for TinniLogic Mobile Tinnitus Management D..., manufactured by Jiangsu Betterlife Medical Co., Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K163094 · Jiangsu Betterlife Medical Co., Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
194d
Days
Class 2
Risk

K163094 is an FDA 510(k) clearance for the TinniLogic Mobile Tinnitus Management Device. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Jiangsu Betterlife Medical Co., Ltd. (Changshu, CN). The FDA issued a Cleared decision on May 17, 2017 after a review of 194 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3400 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Jiangsu Betterlife Medical Co., Ltd. devices

FDA 510(k) Submission Details - K163094

510(k) Number K163094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2016
Decision Date May 17, 2017
Days to Decision 194 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 90d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLW Device Classification - Class 2, Special Controls

Product Code KLW Masker, Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3400
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Mid-Link Consulting Co, Ltd.
DIANA HONG

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 - KLW Masker, Tinnitus

All 60
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K163094.
Tinnitus Sound Generator Module
K180495 · GN Hearing A/S · Nov 2018
Tinnitus Sound Generator Module
K181586 · GN Hearing A/S · Jul 2018
audifon Tinnitus-Module
K171243 · Audiofon USA, Inc. · Oct 2017
Sound Options Tinnitus Treatment
K161562 · Sound Options Tinnitus Treatments, Inc. · Sep 2016
HyperSound Tinnitus Module
K161331 · Turtle Beach Corporation · Aug 2016
Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System
K151558 · Neurotherapies Reset GmbH · Jan 2016