Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5365](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5365) → BYN — Chair, Posture, For Cardiac And Pulmonary Treatment

# BYN · Chair, Posture, For Cardiac And Pulmonary Treatment

_Anesthesiology · 21 CFR 868.5365 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYN

## Overview

- **Product Code:** BYN
- **Device Name:** Chair, Posture, For Cardiac And Pulmonary Treatment
- **Regulation:** [21 CFR 868.5365](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5365)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A posture chair for cardiac or pulmonary treatment is a device intended to assist in the rehabilitation and mobilization of patients with chronic heart or lung disease.

## 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 § 868.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K873039](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYN/K873039.md) | MODEL 820 TOP=TRAK | Sierra Laboratories, Inc. | Feb 11, 1988 | SESE |

## Top Applicants

- Sierra Laboratories, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYN](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYN)

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