Clearance Summary
HAYDAY IRRIT-EASER WAND received FDA 510(k) clearance under submission number K840035, sponsored by Hayday Irrit-Easer. 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 1984-01-30.
- Submission: K840035
- Applicant / Sponsor: Hayday Irrit-Easer
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1984-01-30
Classification & Regulation
This clearance is catalogued under FDA product code ISA and 21 CFR 890.5660, within the Physical Medicine review panel as a Class I device.