Cleared Traditional

RF-Relief

K181095 · El Global Trade, Ltd. · General & Plastic Surgery

Jul 2018

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K181095 is an FDA 510(k) clearance for the RF-Relief, 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 24, 2018, 89 days after receiving the submission on April 26, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K181095 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2018
Decision Date	July 24, 2018
Days to Decision	89 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.