VICHY SHOWER

K980909 · Bouvier Hydro, Inc. · ILJ · Aug 11, 1998 · Physical Medicine

Device Facts

• Record ID: K980909
• Device Name: VICHY SHOWER
• Applicant: Bouvier Hydro, Inc.
• Product Code: ILJ · Physical Medicine
• Decision Date: Aug 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vichy Shower 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 tissue.

Device Story

Vichy Shower is a hydrotherapy device used in clinical or spa settings. It delivers water to the patient's body to facilitate pain relief, alleviate itching, and assist in the healing of inflamed or traumatized tissue. The device functions as a setting for tissue removal. It is operated by healthcare professionals or trained personnel. The device provides therapeutic water application to the patient, which the clinician uses to manage symptoms and support wound or tissue care. The primary benefit is the provision of a controlled hydrotherapy environment for patient treatment.

Technological Characteristics

Hydrotherapy device; water-based delivery system. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for patients requiring hydrotherapy for pain relief, itching, or the treatment of inflamed and traumatized tissue, including the removal of 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 a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | | 1998

Ms. Joyce M. Duquette · Fritz Companies, Inc. Representing Bouvier Hydro Inc. 100 Walnut Street, Suite 20 P.O. Box 2874 Champlain, New York 12919

Re: K980909 Trade Name: Vichy Shower Regulatory Class: II Product Code: ILJ Dated: April 14, 1998 Received: June 15, 1998

Dear Ms. Duquette:

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 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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.

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

## Page 2 - Ms. Joyce M. Duquette

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,

Stephen Edwards

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): | K980909 |
|---------------------------|--------------|
| Device Name: | Vichy Shower |

Indications For Use:

-JUL.29.1998 -- 11:4422-""

Vichy Shower is used in hydrotherapy to relieve pain and itching
and and and in the healing process of inflamed and trauminated Vichy Shower is used in hydrotherapy to relieve parn and traumatized
and as an aid in the healing process of inflamed and traumated Vichy Shower 1s Used Timber of intribution of Creations
and as an aid in the healing process of intribution of contaminated
tissue, and it serves as a setting for removal of tissue .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

NOT WRIDE of CDRH, Office of Device Evaluation (ODE)

Stuptim Rhodes

General Restorative De

OR

Over-The-Counter Use X*_*_

• • •

Prescription Use (Per 21 CFR 801.109)

(Optional Forms: 1-2-96)