A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM

K992779 · Medi-Man Rehabilitation Products, Inc. · ILJ · Jan 13, 2000 · Physical Medicine

Device Facts

• Record ID: K992779
• Device Name: A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
• Applicant: Medi-Man Rehabilitation Products, Inc.
• Product Code: ILJ · Physical Medicine
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5100
• Device Class: Class 2

Intended Use

Bath for the bathing of disabled persons.

Device Story

A-2000 Bathing Systems and Hydrosonic Bathing System are specialized tubs designed for bathing disabled individuals. These systems facilitate hygiene for patients with mobility impairments. Operated by caregivers in clinical or rehabilitation settings, the device provides a safe environment for patient bathing. The system functions as a mechanical aid to assist in the physical process of cleaning patients who cannot use standard bathing facilities independently.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical bathing system for disabled persons. No specific materials, energy sources, or software algorithms described in the provided documentation.

Indications for Use

Indicated for the bathing of disabled persons.

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

JAN 1 3 2000

Mr. John T. Mogensen Vice President. Production, Service, Regulatory Affairs Medi-Man Rehabilitation Products, Inc. 6200A Tomken Road, Mississauga Ontario, Canada L5T 1X7

Re: K992779

> Trade Name: A-2000 Bathing Systems; Hydrosonic Bathing System Regulatory Class: II Product Code: ILJ Dated: December 1, 1999 Received: December 7, 1999

Dear Mr. Mogensen:

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 (OS) 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.

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.

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Page 2 - Mr. Keshishyan

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,

Mark McMillan

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (K) Number K992779 GK-Diana Bathing System

Indications for Use:

Bath for the bathing of disabled persons.

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

Concurrence of CDRH, Office of Device Evaluation Over-The-Counter_ Prescription Use OR (Per 21 CFR 801.109) (Optional Format 1-2-96)

Mark A. Milken

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