Clearance Summary
RUBBER INFLATABLE RING received FDA 510(k) clearance under submission number K823903, sponsored by Duro-Med Ind., 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 1983-01-14.
- Submission: K823903
- Applicant / Sponsor: Duro-Med Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3175
- Decision date: 1983-01-14
Classification & Regulation
This clearance is catalogued under FDA product code KIC and 21 CFR 890.3175, within the Physical Medicine review panel as a Class I device.