Clearance Summary
Beactive Brace received FDA 510(k) clearance under submission number K151476, sponsored by Natures Pillows, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2016-02-26.
- Submission: K151476
- Applicant / Sponsor: Natures Pillows, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 2016-02-26
Classification & Regulation
This clearance is catalogued under FDA product code PMV and 21 CFR 890.3475, within the Physical Medicine review panel as a Class I device.