Clearance Summary
EDCOOL AND EDCOOL JR. INSTANT COLD PACK received FDA 510(k) clearance under submission number K871006, sponsored by Advantage Credit Services, 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 1987-03-25.
- Submission: K871006
- Applicant / Sponsor: Advantage Credit Services, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3920
- Decision date: 1987-03-25
Classification & Regulation
This clearance is catalogued under FDA product code IMP and 21 CFR 890.3920, within the Physical Medicine review panel as a Class I device.