HYDROTONE

K974321 · North American Technical Services Corp. · ILJ · Jun 22, 1998 · Physical Medicine

Device Facts

• Record ID: K974321
• Device Name: HYDROTONE
• Applicant: North American Technical Services Corp.
• Product Code: ILJ · Physical Medicine
• Decision Date: Jun 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5100
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Hydrotherapy - relieve pain and itching

Device Story

Hydrotone is a hydrotherapy system designed to provide pain and itching relief through water immersion. Operated by the user, the device functions as a therapeutic bath. Safety precautions are critical due to risks of hyperthermia; users are advised against use with alcohol, drugs, or after strenuous exercise. The device is intended for general use, with specific warnings for vulnerable populations including children, the elderly, and the handicapped, who require supervision. Clinical benefit is derived from the therapeutic application of water to alleviate physical discomfort.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hydrotherapy system; water-based immersion device. No specific materials, connectivity, or software algorithms described.

Indications for Use

Indicated for hydrotherapy to relieve pain and itching. Contraindicated for children, elderly, or handicapped individuals unless supervised. Not for use following strenuous exercise. Pregnant women must consult a physician. Consult a physician if using medication. Do not use with alcohol or drugs due to risk of fatal hyperthermia.

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

JUN 22 1998

Mr. Richard C. Lanzillotto Agent for Tradex Holdings Party Limited North American Technical Services Corporation 30 Northport Road 11789-1734 Sound Beach, New York

K974321 Re: Hydrotone Trade Name: Regulatory Class: II Product Code: ILJ Dated: April 14, 1998 Received: April 16, 1998

Dear Mr. Lanzillotto:

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. ਜੋ 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 regulations.

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## Page 2 - Mr. Richard C. Lanzillotto

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 the regaration Chercled) Hisbianant BJ 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. Whitton, Ph.D.

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

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K974321 510K Notification

## INDICATIONS FOR USE

| 510(k) Number (if known): | K974321 |
|---------------------------|---------|
|---------------------------|---------|

=

Device Name:

Hydrotone

Indications for Use:

Hydrotherapy - relieve pain and itching

Contraindications:

Not for children, elderly or handicapped unless supervised.

- Prolonged immersion in hot water may induce hyperthermia. (
- Do not use following strenuous exercise.
- Pregnant women should consult a medical doctor before using this system.
- Consult with a medical doctor if using medication prior to using this system.
- Do not use with alcohol or drugs. The combination could result in fatal hyperthermia.

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

Concurrence of CDRH, Office of Device Evaluation (OL

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974321

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

NATS Corp.