Clearance Summary
AKUFON THERAPEUTIC MASSAGER received FDA 510(k) clearance under submission number K850495, sponsored by Jansson A/S. 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 1986-01-03.
- Submission: K850495
- Applicant / Sponsor: Jansson A/S
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5975
- Decision date: 1986-01-03
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.