Cleared Traditional

K160835 - Titan 3W

K160835 is an FDA 510(k) clearance for Titan 3W, manufactured by Tzora Active Systems , Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K160835 · Tzora Active Systems , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
314d
Days
Class 2
Risk

K160835 is an FDA 510(k) clearance for the Titan 3W. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Tzora Active Systems , Ltd. (Kibbutz Tzora, IL). The FDA issued a Cleared decision on February 2, 2017 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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. Elevated predicate reliance profile. 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 Tzora Active Systems , Ltd. devices

FDA 510(k) Submission Details - K160835

510(k) Number K160835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2016
Decision Date February 02, 2017
Days to Decision 314 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
199d slower than avg
Panel avg: 115d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INI Device Classification - Class 2, Special Controls

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
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

A. Stein - Regulatory Affairs Consulting , Ltd.
Moshe Rosenberg

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 - INI Vehicle, Motorized 3-wheeled

All 211
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K160835.
Quingo Flyte Mobility Scooter
K171256 · Agile Distributors, LLC · Jun 2017
C.T.M. Mobility Scooter
K162952 · Chien TI Enterprise Co., Ltd. · May 2017
KYMCO EQ10D Scooter
K163201 · Kwang Yang Motor Co., Ltd. · Mar 2017
ATTO Mobility Scooter
K160909 · Moving Life, Ltd. · Oct 2016
HEARTWAY Power Mobility Scooter
K151656 · Heartway Medical Products Co., Ltd. · Nov 2015
HEARTWAY Power Mobility Scooter
K150998 · Heartway Medical Products Co., Ltd. · Sep 2015