Clearance Summary
SHOWER-A-WAY received FDA 510(k) clearance under submission number K902951, sponsored by Tri-S-Sales and Mfg.. 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 1990-07-25.
- Submission: K902951
- Applicant / Sponsor: Tri-S-Sales and Mfg.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3100
- Decision date: 1990-07-25
Classification & Regulation
This clearance is catalogued under FDA product code INN and 21 CFR 890.3100, within the Physical Medicine review panel as a Class I device.