IMF · Unit, Chilling
Physical Medicine · 21 CFR 890.5940 · Class 1
Overview
| Product Code | IMF |
|---|---|
| Device Name | Unit, Chilling |
| Regulation | 21 CFR 890.5940 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A chilling unit is a refrigerative device intended for medical purposes to chill and maintain cold packs at a reduced temperature.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K900419 | CRYOTRON-UL30 | Henley Intl. | Feb 27, 1990 | SESE |
| K871112 | PELTIERTHERAPY(C) HEAT/COLD TREATMENT | Henley Intl. | May 6, 1987 | SESE |
Top Applicants
- Henley Intl. — 2 clearances
