MPOWRX SNORING SOLUTION— 510(k) K081965

Substantially Equivalent

Mpowrx Health and Wellness Products, Inc.

FDA 510(k) clearance K081965 for MPOWRX SNORING SOLUTION, Substantially Equivalent on 2008-10-27. Applicant: Mpowrx Health and Wellness Products, Inc..

Clearance details

Applicant
Mpowrx Health and Wellness Products, Inc.
Product code
Code LRK
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Austin, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LRK

product code LRK
Injury
246
Malfunction
1,044
Total
1,290

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.