Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5940](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5940) → IMF — Unit, Chilling

# IMF · Unit, Chilling

_Physical Medicine · 21 CFR 890.5940 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMF

## Overview

- **Product Code:** IMF
- **Device Name:** Unit, Chilling
- **Regulation:** [21 CFR 890.5940](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5940)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)

## 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMF/K900419.md) | CRYOTRON-UL30 | Henley Intl. | Feb 27, 1990 | SESE |
| [K871112](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMF/K871112.md) | PELTIERTHERAPY(C) HEAT/COLD TREATMENT | Henley Intl. | May 6, 1987 | SESE |

## Top Applicants

- Henley Intl. — 2 clearances

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMF](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMF)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com