MPowRx Snoring Solution (also known as Good Morning Snore Solution)— 510(k) K193239
Substantially EquivalentMpowrx Health and Wellness Products 2012, Inc.
FDA 510(k) clearance K193239 for MPowRx Snoring Solution (also known as Good Morning Snore Solution), Substantially Equivalent on 2020-01-03. Applicant: Mpowrx Health and Wellness Products 2012, Inc..
Clearance details
- Applicant
- Mpowrx Health and Wellness Products 2012, Inc.
- Product code
- Code LRK
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Calgary, CA
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.