Clearance Summary
PERSONAL SITZ BATH KIT received FDA 510(k) clearance under submission number K800958, sponsored by The Healthcare Group Laboratories, 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 1980-05-02.
- Submission: K800958
- Applicant / Sponsor: The Healthcare Group Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5125
- Decision date: 1980-05-02
Classification & Regulation
This clearance is catalogued under FDA product code KTC and 21 CFR 890.5125, within the Physical Medicine review panel as a Class I device.