Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3670](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3670) → KRF — Charger, Pacemaker

# KRF · Charger, Pacemaker

_Cardiovascular · 21 CFR 870.3670 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRF

## Overview

- **Product Code:** KRF
- **Device Name:** Charger, Pacemaker
- **Regulation:** [21 CFR 870.3670](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3670)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable pacemaker.

## 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 § 870.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRF](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRF)

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