Forza— 510(k) K260136
Substantially EquivalentTrue Function Laboratory, Inc.
FDA 510(k) clearance K260136 for Forza, Substantially Equivalent on 2026-10-06. Applicant: True Function Laboratory, Inc.. Device class: 2.
Summary
Forza from True Function Laboratory is filed under LRK, anti-snoring devices. The record doesn't describe the design beyond the product code.
Class II, 21 CFR 872.5570. The Dental panel reviewed it, and it came in as an Abbreviated 510(k).
True Function Laboratory filed from La Mesa, California. Review took 263 days (January 16 to October 6, 2026).
Clearance details
- Applicant
- True Function Laboratory, Inc.
- Product code
- Product code LRK
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- La Mesa, CA, US
Recent devices under product code LRK
view allMore clearances from True Function Laboratory, Inc.
view allAdverse 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.