Hill-Rom Patient Environmental Control System

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K921528Ref P8000

by Hill-Rom, Inc.

Identity

Trade Name: Hill-Rom EUDAMED
Procedural stretcher FDA UDI
Generic Name: Hospital stretcher, manual FDA UDI
Device Name: Hospital Stretcher EUDAMEDFDA UDI
Model / Reference: P8000 EUDAMED
P8000H FDA UDI
Description: Hospital Stretcher FDA UDI

Identifiers

Primary DI / UDI-DI: 00887761000957 EUDAMEDFDA UDI
Basic UDI-DI: 0887761GMN000041U2 EUDAMED
Direct Marketing DI: 00887761000957 EUDAMED
510(k) Number: K921528 FDA 510(k)
FDA Product Code: IQA FDA 510(k)
FPO FDA UDI
EMDN Code: V08050101 GENERIC USE STRETCHERS EUDAMED
GMDN Term: Hospital stretcher, manual FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 890.3725 FDA 510(k)
Regulation Number: 890.3725 FDA 510(k)
880.6910 FDA UDI
Market of Registration: France EUDAMED
Advisory Committee: Physical Medicine FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Hill-Rom Patient Environmental Control System is a powered environmental control system designed to regulate a patient’s surroundings. It integrates climate control, lighting, and other environmental parameters to create a stable and comfortable environment for patients, particularly in clinical settings such as physical medicine or rehabilitation.

This system is intended for use in healthcare facilities and is supplied as a reusable device. It operates within standard electrical and environmental safety parameters, with no specific MRI safety restrictions noted. Multiple model variants are registered, each corresponding to distinct configurations or features, and the device complies with FDA 510(k) clearance and EU MDR requirements. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and hygiene.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K921528	Class II	Active

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Manufacturer

Manufacturer: Hill-Rom, Inc.

Sources (3)

FDA 510(k) K921528 24 fields · synced Sep 18, 2026
FDA UDI 777d7d18-d9ee-42fd-914d-9882ee1127ca 34 fields · synced May 30, 2026
EUDAMED e9f6aa76-16c3-4c35-8992-77077e7d8952 61 fields · synced Jul 30, 2026