Clearance Summary
TRU-COLD THERAPY PAK received FDA 510(k) clearance under submission number K800917, sponsored by Tru-Eze Mfg. 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 1980-05-02.
- Submission: K800917
- Applicant / Sponsor: Tru-Eze Mfg. Co., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5700
- Decision date: 1980-05-02
Classification & Regulation
This clearance is catalogued under FDA product code IME and 21 CFR 890.5700, within the Physical Medicine review panel as a Class I device.