Cleared Traditional

K170637 - sensiFirm

K170637 is an FDA 510(k) clearance for sensiFirm, manufactured by El Global Trade, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code PBX cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K170637 · El Global Trade, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
134d
Days
Class 2
Risk

K170637 is an FDA 510(k) clearance for the sensiFirm. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by El Global Trade, Ltd. (Netanya, IL). The FDA issued a Cleared decision on July 14, 2017 after a review of 134 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 El Global Trade, Ltd. devices

FDA 510(k) Submission Details - K170637

510(k) Number K170637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2017
Decision Date July 14, 2017
Days to Decision 134 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
19d slower than avg
Panel avg: 115d · This submission: 134d
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 66
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K170637.
truSculpt RF Device
K180709 · Cutera, Inc. · Jun 2018
Ultimate Contour, Ultimate Contour Mini
K171052 · CAO Group, Inc. · Oct 2017
truSculpt
K172004 · Cutera, Inc. · Aug 2017
Exilis XP II
K163176 · BTL Industries, Inc. · Jan 2017
truSculpt
K162512 · Cutera, Inc. · Dec 2016
TR-100
K161551 · BTL Industries, Inc. · Sep 2016