Clearance Summary
MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS received FDA 510(k) clearance under submission number K932240, sponsored by Bailey Mfg. 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 1994-04-01.
- Submission: K932240
- Applicant / Sponsor: Bailey Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1994-04-01
Classification & Regulation
This clearance is catalogued under FDA product code IRR and 21 CFR 890.5380, within the Physical Medicine review panel as a Class I device.