Clearance Summary
BACK MASSAGER B-400 ADJUSTABLE received FDA 510(k) clearance under submission number K832913, sponsored by Pollenex Associated Mills, 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 1983-11-07.
- Submission: K832913
- Applicant / Sponsor: Pollenex Associated Mills, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1983-11-07
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.