Clearance Summary
AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER received FDA 510(k) clearance under submission number K925907, sponsored by Pollenex Corp.. 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 1994-03-30.
- Submission: K925907
- Applicant / Sponsor: Pollenex Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1994-03-30
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.