FERNO HEALTHCARE RECLINE-A-BATH 2

K980033 · Ferno-Washington, Inc. · ILJ · Apr 21, 1998 · Physical Medicine

Device Facts

• Record ID: K980033
• Device Name: FERNO HEALTHCARE RECLINE-A-BATH 2
• Applicant: Ferno-Washington, Inc.
• Product Code: ILJ · Physical Medicine
• Decision Date: Apr 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reclin-A-Bath 2 is indicated for use with patients to relieve pain and itching. The Reclin-A-Bath 2 is indicated for use with patients to aid in the healing process of inflamed and traumatized tissue. The Reclin-A-Bath 2 is indicated for use with patients to serve as a setting for the removal of contaminated tissue.

Device Story

Recline-A-Bath 2 is a hydrobath device used to facilitate patient hygiene and wound care. It provides a controlled environment for soaking, which aids in pain/itching relief, tissue healing, and debridement of contaminated tissue. Operated in clinical or home settings, the device functions as a specialized tub/bath system. It assists healthcare providers or caregivers in managing patient hygiene and wound maintenance, potentially improving patient comfort and recovery outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hydrobath system; mechanical device for patient immersion. No software, electronics, or complex materials specified.

Indications for Use

Indicated for patients requiring relief from pain and itching, aid in healing of inflamed or traumatized tissue, and a setting for removal of contaminated tissue.

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

APR 21 1998

Mr. Eric N. Besanko 'Director, Quality Assurance and Regulatory Affairs Ferno-Washington, Inc. 70 Weil Way 45177-9371 Wilmington, Ohio

K980033 Re: Ferno Healthcare Recline-A-Bath 2 Regulatory Class: II Product Code: ILJ Dated: April 2, 1998 Received: April 6, 1998

Dear Mr. Besanko:

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 Regulations, Title 21, Parts 800 to 895. ಗಿ 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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## Page 2 - Mr. Eric N. Besanko

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,

D. Gale M. Witter, Ph.D., M

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

Enclosure

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## CONFIDENTIAL

## Attachment 1

## Indications for use of the Recline-A-Bath 2 Hydrobath

The Reclin-A-Bath 2 is indicated for use with patients to relieve pain and itching.

The Reclin-A-Bath 2 is indicated for use with patients to aid in the healing process of inflamed and traumatized tissue.

The Reclin-A-Bath 2 is indicated for use with patients to serve as a setting for the removal of contaminated tissue. --------------

**Over-the-Counter Use**

Division Sign Off

Divisio General Restorative Devic 510(k) Number