← Product Code [IRN](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN) · K792241

# PELIMIT (K792241)

_Colmed, Ltd. · IRN · Nov 30, 1979 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K792241

## Device Facts

- **Applicant:** Colmed, Ltd.
- **Product Code:** [IRN](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN.md)
- **Decision Date:** Nov 30, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5575
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.

## Special Controls

*Classification.* Class II (special 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.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K792241](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K792241)

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