Cleared Traditional

K162828 - Winback Back 3SE

K162828 is an FDA 510(k) clearance for Winback Back 3SE, manufactured by Winback USA Corp. The device is a Class 2 General & Plastic Surgery device with product code PBX cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K162828 · Winback USA Corp · General & Plastic Surgery device
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Sep 2017
Decision
346d
Days
Class 2
Risk

K162828 is an FDA 510(k) clearance for the Winback Back 3SE. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Winback USA Corp (Dripping Springs, US). The FDA issued a Cleared decision on September 18, 2017 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Winback USA Corp devices

FDA 510(k) Submission Details - K162828

510(k) Number K162828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2016
Decision Date September 18, 2017
Days to Decision 346 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 115d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBX Device Classification - Class 2, Special Controls

Product Code PBX Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

All 69
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K162828.
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Exilis XP II
K163176 · BTL Industries, Inc. · Jan 2017
truSculpt
K162512 · Cutera, Inc. · Dec 2016