Clearance Summary
VIBROFLEX received FDA 510(k) clearance under submission number K863197, sponsored by Stoffregen & Co., 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 1986-09-19.
- Submission: K863197
- Applicant / Sponsor: Stoffregen & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1986-09-19
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.