VAIL 1000 ENCLOSED BED

K982783 · Vail Products, Inc. · FNL · Oct 5, 1998 · General Hospital

Device Facts

• Record ID: K982783
• Device Name: VAIL 1000 ENCLOSED BED
• Applicant: Vail Products, Inc.
• Product Code: FNL · General Hospital
• Decision Date: Oct 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5100
• Device Class: Class 2

Indications for Use

The Vail 1000 Enclosed Bed is a soft-sided enclosed bed for patients who are at risk to harming themselves or others by intentionally or unintentionally leaving the bed unasisted

Device Story

Vail 1000 Enclosed Bed is a soft-sided enclosure system designed to prevent unassisted bed exit. Device functions as a physical barrier to mitigate risks of patient injury from falls or wandering. Used in clinical or home settings; operated by caregivers or healthcare staff. Provides a secure environment for patients prone to leaving bed without assistance. Benefits include enhanced patient safety and reduced risk of harm.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Soft-sided enclosed bed system. Mechanical design for patient containment. No electronic, software, or energy-based components described.

Indications for Use

Indicated for patients at risk of self-harm or harming others due to intentional or unintentional unassisted bed exit.

Regulatory Classification

Identification

An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The text is in all caps and is in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 1098

Ms. Nancy Vail Vail Products, Incorporated 235 First Street Toledo, Ohio 43605

Re : K982783 Vail 1000 Enclosed Bed Trade Name: Regulatory Class: İI Product Code: FNL Dated: September 16, 1998 Received: September 17, 1998

Dear Ms. Vail:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

Page 2 - Ms. Vail

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" .

Sincerely yours

Timothy A. Ulatowski

Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page 1 of 1

510(k) Number (if known):

Device Name:__Vail_1000_Enclosed_Red_

Indications For Use:

The Vail 1000 Enclosed Bed is a soft-sided enclosed bed for patients who are at risk to harming themselves or others by intentionally or unintentionally leaving the bed unasisted

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pulchera Crescenti

Division Sign-Division of Dental, Infection Control. and General Hospital Devices

510(k) Number 1982783

Prescription Use (Per 21 CFR 801.109)

្រី

OR

Over-The-Counter Use_

(Optional Format 1-2-96)