EQUINOXE

K980920 · Bouvier Hydro, Inc. · ILJ · Jul 16, 1998 · Physical Medicine

Device Facts

• Record ID: K980920
• Device Name: EQUINOXE
• Applicant: Bouvier Hydro, Inc.
• Product Code: ILJ · Physical Medicine
• Decision Date: Jul 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Relieve pain and itching, as an aid in the healing process of inflamed and traumatized tissue, and serve as a settting for removal of contamined tissue.

Device Story

Equinoxe Spa Tub; hydrotherapy device used for physical therapy or wound care. Provides water-based treatment to relieve pain/itching, promote healing of inflamed/traumatized tissue, and facilitate removal of contaminated tissue. Operated in clinical or home settings by patients or healthcare providers. Device functions as a therapeutic bath; water immersion provides physical relief and cleansing environment. Benefits include improved patient comfort and wound management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hydrotherapy spa tub; mechanical device for water immersion. No software, electronic sensing, or complex algorithms. Materials and construction details not specified.

Indications for Use

Indicated for patients requiring relief from pain and itching, aid in healing of inflamed or traumatized tissue, and as a setting for the 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)

{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 a stylized caduceus or a representation of human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 1998

Mr. Alain Jouan ·President Fritz Companies, Inc. Representing Bouvier Hydro Inc. 100 Walnut Street, Door 20 P.O. Box 2874 12919 Champlain, New York

K980920 Re: Equinoxe Spa Tub Trade Name: Regulatory Class: II Product Code: ILJ Dated: June 23, 1998 June 25, 1998 Received:

Dear Mr. Jouan:

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 Requlations, 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 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.

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

## Page 2 - Mr. Alain Jouan

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 requlation (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

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

510(k) Number (if known): K 980920 EQUINOXE Device Name:_

Indications For Use:

Relieve pain and itching, as an aid in the healing process of inflamed and traumatized tissue, and serve as a settting for removal of contamined tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices, 2/28/73

(Division Sign-On)
Division of General Restorative Devices 510(k) Number

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use ⦸

(Optional Format 1-2-96)