Clearance Summary
EBI HAND MASSAGING PUMP (HMP) received FDA 510(k) clearance under submission number K860632, sponsored by Electro-Biology, 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 1986-04-18.
- Submission: K860632
- Applicant / Sponsor: Electro-Biology, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 1986-04-18
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.