Cleared Traditional

sensiFirm

K170637 · El Global Trade, Ltd. · General & Plastic Surgery
Jul 2017
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K170637 is an FDA 510(k) clearance for the sensiFirm, a Massager, Vacuum, Radio Frequency Induced Heat (Class II — Special Controls, product code PBX), submitted by El Global Trade, Ltd. (Netanya, IL). The FDA issued a Cleared decision on July 14, 2017, 134 days after receiving the submission on March 2, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K170637 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code PBX — Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class II — 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.