BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC

K964926 · Joerns Healthcare, Inc. · ILJ · Nov 3, 1997 · Physical Medicine

Device Facts

• Record ID: K964926
• Device Name: BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
• Applicant: Joerns Healthcare, Inc.
• Product Code: ILJ · Physical Medicine
• Decision Date: Nov 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To relieve pain and itching and as an aid in the healing of inflamed and traumatized tissue and as a setting for removal of contaminated tissue.

Device Story

Parker Bath System is a fiberglass tub and base unit for patient bathing and hydro-massage therapy. Features include thermostatically controlled water mixing valve, shower hose, soap dispenser, and air jet system. Tub allows vertical movement and tilting (upright to reclined) via manual hydraulic or 24 VDC battery-powered electro-hydraulic pump. Patient enters through pivoting side door while upright; footwell pre-filled with warm water. Air spa blower provides hydromassage for podiatry or full-body therapy. Used in hospitals, nursing homes, or home settings by caregivers. Thermostat pre-set to max 107.5°F for safety. Post-use disinfection involves flushing blower jets and rinsing tub surfaces. Benefits include pain/itching relief, tissue healing aid, and contaminated tissue removal.

Clinical Evidence

No clinical data provided. Device relies on established nursing care principles and historical use of immersion hydrotherapy for pain relief and tissue healing.

Technological Characteristics

Fiberglass construction; 24 VDC battery-powered or manual hydraulic pump for vertical/tilt movement; air spa blower system; thermostatically controlled mixing valve (max 107.5°F); pivoting side door; integral shower hose.

Indications for Use

Indicated for patients requiring bathing and hydro-bath therapy for pain/itching relief, healing of inflamed/traumatized tissue, or removal of contaminated tissue. Suitable for use in hospitals, nursing homes, or home settings.

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.

Predicate Devices

• Arjo-Century Arm and Leg Tank (K923637)
• Ferno Ille Hi-Lo Jr. Mobile Whirlpool (K914125)
• Arjo-Century Spa Shell (K904106)
• Parker Bath System (K883308)

Submission Summary (Full Text)

{0}

510 (k) SUMMARY

Submitter: Joerns Healthcare, Inc.
5001 Joerns Drive
Stevens Point, WI 54481-5040
Ph: [phone]
Dean Sommerfeld
November 20, 1996 / Revised February 24, 1997

K964926
NOV - 3 1997

Device Name: Parker Bath System

Generic Name: Bathing Systems

Classification Name: Bath, hydro-massage (89ILJ)
Class II per 21 C.F.R. § 890.5100 (immersion
hydrobath)

Predicate Devices: Arjo-Century Arm and Leg Tank K923637
Ferno Ille Hi-Lo Jr. Mobile Whirlpool K914125
Arjo-Century Spa Shell K904106
Parker Bath System K883308

Description:
The Parker Bath System consists of a fiberglass base unit and a movable fiberglass tub unit. The base unit contains the air spa blower unit and the battery pack, charger, and electro-hydraulic unit for moving the tub on models with electro-hydraulic powered movement. The tub unit contains the thermostatically controlled water mixing valve, shower hose, soap dispenser and air jet system.

Some of the Parker Bath System models allow the tub to be moved vertically for ease of entry/exit of the patient and for ease of access for the caregiver. The vertical movement is powered either by a manual hydraulic pump or a 24 VDC battery powered electro-hydraulic pump unit. The tub units can all be tilted from an upright position for entry/exit/podiatry therapy to a fully reclined position for full body bathing/therapy. The tilting is powered either by a manual hydraulic pump or a 24 VDC battery powered electro-hydraulic pump unit.

The patient enters the tub though a pivoting side door and sits on a molded in seat while the tub is in the upright position. The footwell of the tub can be prefilled with warm water through the thermostatically controlled mixing valve prior to the patient entering the tub. After the door is closed and latched, the air spa blower can be turned on for podiatry and lower leg hydromassage therapy, or the tub can be reclined, allowing the water to flow up and around the patient at which point bathing can be done using the integral shower hose or the air spa blower can be turned on for a full body hydromassage. After the bath the tub is tilted to the upright position, the water flows back to the footwell and the patient can be dried off and clothed while the water flows out the drain in the footwell.

2

{1}

3

After the patient exits the tub, the tub can be disinfected by flushing the blower jets with disinfecting solution through a disinfecting port at the highest point of the blower piping. The inside of the tub can then be rinsed down with disinfecting solution and after the appropriate length of time the pipes and tub can be flushed and rinsed with clear water.

The Parker Bath System provides a safe method for the bathing and hydro-bath therapy of the patient. The hydrobath therapy is used 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 the removal of contaminated tissue.

The Parker Bath System should only be used as described in the operations manual and is intended to be used in concert with well established nursing care principles.

The Parker Bath System has been designed to be safely used in the hospital, nursing home, or the home setting. The thermostat has been pre-set during manufacturing for a maximum allowable water temperature of approximately 107.5° F. Detailed installation instructions included in the operations manual instruct the health care provider in the proper set-up and use of the equipment. In addition, labeling has been provided on the bath unit specifying proper use.

{2}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

NOV - 3 1997

Dean Sommerfeld, P.E.
Product Engineer
Sunrise Medical Continuing Care Group, Inc.
5001 Joerns Drive
Stevens Point, Wisconsin 54481-5040

Re: K964926
Parker Bath System
Regulatory Class: II
Product Code: ILJ
Dated: August 1, 1997
Received: August 5, 1997

Dear Mr. Sommerfeld:

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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.

{3}

Page 2 - Dean Sommerfeld, P.E.

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,


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

Enclosure

{4}

# Indications for Use

510(k) Number (if known): K964926

Device Name: Immersion Hydrobath

Indications for Use: To relieve pain and itching and as an aid in the healing of inflamed and traumatized tissue and as a setting for removal of contaminated tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☐ OR Over-The-Counter Use ☑ (Per 21 CFR 801.109)