← Product Code [IRT](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT) · K881800

# BCS NO. 1, BODY CARE SYSTEM (K881800)

_M & A Vertrieb, Liske Und Methling GM · IRT · Nov 16, 1988 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K881800

## Device Facts

- **Applicant:** M & A Vertrieb, Liske Und Methling GM
- **Product Code:** [IRT](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT.md)
- **Decision Date:** Nov 16, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5740
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K881800](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K881800)

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