Clearance Summary
CONSTI-SSAGE VIBRATOR/MASSAGE received FDA 510(k) clearance under submission number K900674, sponsored by Bio-Tech Co.. 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 1990-03-02.
- Submission: K900674
- Applicant / Sponsor: Bio-Tech Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1990-03-02
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.