PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM

K040772 · Penner Manufacturing, Inc. · ILJ · Apr 5, 2004 · Physical Medicine

Device Facts

• Record ID: K040772
• Device Name: PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
• Applicant: Penner Manufacturing, Inc.
• Product Code: ILJ · Physical Medicine
• Decision Date: Apr 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5100
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Pacific Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only. The Pacific Bath will not be marketed for therapeutic or other medical uses.

Device Story

Pacific Recumbent Height Adjustable Bath is a mechanical bathing system for patients in clinical or residential care settings. Device features height-adjustable design to facilitate patient transfer and caregiver access. Operated by trained personnel in hospitals, nursing homes, or assisted living facilities. Provides a physical environment for hygiene; does not provide therapeutic or medical treatment. Benefits include improved ergonomics for caregivers and safe, accessible bathing for patients with limited mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Height-adjustable recumbent bath system. Mechanical design for patient immersion. Class II device under 21 CFR 890.5100. No software or electronic sensing components described.

Indications for Use

Indicated for bathing patients or residents in nursing homes, hospitals, and assisted living facilities. Intended for use by trained personnel only. Not indicated for therapeutic or medical use.

Regulatory Classification

Identification

An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized stripes or lines, possibly representing an eagle or a similar emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 5 2004

Penner Manufacturing, Inc. C/o Ms. Chantel Carson Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062-2092

Re: K040772

Trade/Device Name: Pacific Recumbent Height Adjustable Bath Regulation Number: 21 CFR 890.5100 Regulation Name: Immersion hydrobath Regulatory Class: II Product Code: ILJ Dated: March 24, 2004 Received: March 26, 2004

Dear Ms. Carson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

## Page 2 – Ms. Chantel Carson

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark N Millam

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known):

Pacific Recumbent Height Adjustable Bath Device Name:

Indications For Use:

The Pacific Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only. The Pacific Bath will not be marketed for therapeutic or other medical uses.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Milliken

and Neurologic

Page 1 of

5100 Number K040772