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 890.5180](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5180) → INY — Bed, Patient Rotation, Manual

# INY · Bed, Patient Rotation, Manual

_Physical Medicine · 21 CFR 890.5180 · Class 1_

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

## Overview

- **Product Code:** INY
- **Device Name:** Bed, Patient Rotation, Manual
- **Regulation:** [21 CFR 890.5180](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5180)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

A manual patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, or to aid circulation.

## 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 § 890.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K851875](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/INY/K851875.md) | KINNET | Kinetic Concepts, Inc. | Aug 22, 1985 | SESE |

## Top Applicants

- Kinetic Concepts, Inc. — 1 clearance

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

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