Clearance Summary
ULTRA WAVE 101 received FDA 510(k) clearance under submission number K905836, sponsored by Ako USA, 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 1991-01-14.
- Submission: K905836
- Applicant / Sponsor: Ako USA, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5975
- Decision date: 1991-01-14
Classification & Regulation
This clearance is catalogued under FDA product code IRO and 21 CFR 890.5975, within the Physical Medicine review panel as a Class I device.