CASCADE BATH, MODEL 6900

K012057 · Penner Manufacturing, Inc. · ILJ · Jul 19, 2001 · Physical Medicine

Device Facts

• Record ID: K012057
• Device Name: CASCADE BATH, MODEL 6900
• Applicant: Penner Manufacturing, Inc.
• Product Code: ILJ · Physical Medicine
• Decision Date: Jul 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5100
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Cascade Bath is intended for bathing patients and/or residents in nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.

Device Story

Cascade Bath Model 6900 is a bathing system designed for use in clinical environments like hospitals, nursing homes, and assisted living facilities. Operated by trained personnel, the device facilitates patient hygiene. It functions as a specialized tub/bath system. The device is intended to assist healthcare staff in providing safe and efficient bathing for patients, potentially improving patient comfort and hygiene maintenance in institutional settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bathing system/tub for institutional use. Class II device (Product Code: ILJ; Regulation: 890.5100).

Indications for Use

Indicated for bathing patients/residents in clinical settings including nursing homes, hospitals, and assisted living facilities. To be operated by trained personnel only.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2001

Penner Manufacturing Inc. c/o Brian R. Biersach Project Engineer Conformity Assessment Services Underwriters Laboratories Inc.® 333 Pfingsten Road Northbrook, Illinois 60062-2096

Re: K012057

Trade Name: Cascade Bath Model 6900 Regulation Number: 890.5100 Regulatory Class: II Product Code: ILJ Dated: June 27, 2001 Received: July 2, 2001

Dear Mr. Biersach:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have roviewed your beceived is substantially equivalent (for the indications for use above und we nave actering marketed predicate devices marketed in interstate commerce stated in the energially to tegally manates of the Medical Device Amendments, or to devices that provision 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 Cosment Act (ree). Tou may) alercrors, arovisions of the Act include requirements for annual provisions of the Feel - Notes, 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 (1 remarket rippt valy in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 mspections, the Food and in 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 roopense to your y the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Brian R. Biersach

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 nonthoution. The I Drivination 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 11 you desire specific diagnostic devices), please contact the Office of Compliance at additionally 60911 o ditionally, for questions on the promotion and advertising of your device, (2017) 594-4639 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Bmt dlleetno or

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

Enclosure

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Attachment Ib

Page 1 of 1

KO12054

New application 510(k) Number (if known):

Cascade Bath Device Name:

Indications For Use:

·

The Cascade Bath is intended for bathing patients and/or The Cascade bath ID Incons, hospitals, and assisted living These baths are to be given by trained facilities. personnel only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Oplional Fornial 1-2-96)

Rsmtheleeehnspon cm

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number k012057