(217 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
Yes
The device is intended to "relieve pain and itching," which are therapeutic benefits.
No
The intended use of the device is for "Hydrotherapy - relieve pain and itching," which describes a therapeutic purpose rather than a diagnostic one.
Unknown
The provided summary lacks a device description, which is crucial for determining if the device is software-only. Without knowing the physical components or how the hydrotherapy is delivered, it's impossible to definitively classify it.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Hydrotherapy - relieve pain and itching." This describes a physical therapy or treatment method applied to the body, not a test performed on biological samples outside the body to diagnose or monitor a condition.
- Device Description: While the description is "Not Found," the intended use strongly suggests a non-IVD device.
- No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples (like blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- No mention of diagnostic or monitoring purpose: The purpose is to "relieve pain and itching," which is a therapeutic or symptomatic relief purpose, not a diagnostic or monitoring one.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's intended use falls outside of that definition.
N/A
Intended Use / Indications for Use
Hydrotherapy - relieve pain and itching
Product codes
ILJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not for children, elderly or handicapped unless supervised.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5100 Immersion hydrobath.
(a)
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.(b)
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.
0
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized eagle or bird in flight.
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.
1
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.