Cleared Traditional

K193239 - MPowRx Snoring Solution (also known as Good Morning Snore Solution) (FDA 510(k) Clearance)

K193239 · Mpowrx Health and Wellness Products 2012, Inc. · Dental device
Jan 2020
Decision
39d
Days
Class 2
Risk

K193239 is an FDA 510(k) clearance for the MPowRx Snoring Solution (also known as Good Morning Snore Solution). This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).

Submitted by Mpowrx Health and Wellness Products 2012, Inc. (Calgary, CA). The FDA issued a Cleared decision on January 3, 2020, 39 days after receiving the submission on November 25, 2019.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number K193239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2019
Decision Date January 03, 2020
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code LRK - Device, Anti-snoring
Device Class Class II - Special Controls
CFR Regulation 21 CFR 872.5570