Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6775](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6775) → FRZ — Device, Patient Transfer, Powered

# FRZ · Device, Patient Transfer, Powered

_General Hospital · 21 CFR 880.6775 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRZ

## Overview

- **Product Code:** FRZ
- **Device Name:** Device, Patient Transfer, Powered
- **Regulation:** [21 CFR 880.6775](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6775)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

A powered patient transfer device is a device consisting of a wheeled stretcher and a powered mechanism that has a broad, flexible band stretched over long rollers that can advance itself under a patient and transfer the patient with minimal disturbance in a horizontal position to the stretcher.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

## 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 § 880.9.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K121929](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRZ/K121929.md) | ZEPHYR 'X-SERIES PATIENT TRANSFER SLED | Diacor, Inc. | Jan 17, 2013 | SESE |
| [K910830](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRZ/K910830.md) | INVALIFT | American Invalift Corp. | Jun 9, 1992 | SESE |
| [K841728](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRZ/K841728.md) | LCI MEDICAL INC AIR/PAL | Lehigh Consolidated Industries | Jun 5, 1984 | SESE |
| [K834585](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRZ/K834585.md) | CELLTRAK-B | R&D Systems, Inc. | May 2, 1984 | SESE |
| [K840796](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRZ/K840796.md) | TENDER LIFTING CARE | Lancer Assoc. | Apr 20, 1984 | SESE |

## Top Applicants

- American Invalift Corp. — 1 clearance
- Diacor, Inc. — 1 clearance
- Lancer Assoc. — 1 clearance
- Lehigh Consolidated Industries — 1 clearance
- R&D Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRZ](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRZ)

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