(147 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses solely on generating deep heat.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "treatment of selected medical conditions."
No
Explanation: The device's intended use is for therapy (generating deep heat for pain relief, muscle spasms, and joint contractures) and not for diagnosing medical conditions.
No
The device description explicitly states that the device "generates deep heat within body tissues," which implies a physical component that produces ultrasonic energy, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as generating deep heat within body tissues for therapeutic purposes (pain relief, muscle spasms, joint contractures). This is a therapeutic application, not a diagnostic one.
- Device Description: The description reinforces the therapeutic function of generating deep heat.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on the body for treatment.
N/A
# Intended Use / Indications for Use
The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
# Product codes
IMI
# 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 Found
# Intended User / Care Setting
Prescription Use
# 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
Not Found
# Key Metrics
Not Found
# Predicate Device(s)
Not Found
# Reference Device(s)
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the circle is a stylized image of an eagle or other bird-like figure.
JUL 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hwang Sun Enterprise Co., LTD. c/o Sing-Hong Yeung Bellaire Industry & Trading Co. 11 Heather Court Middle Island, New York 11953
Re: K050410 R050410
Trade/Device Name: HES® Ultrasonic Therapy Appliance Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: II Product Code: IMI Dated: May 30, 2005 Received: June 3, 2005
Dear Sing-Hong Yeung:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQC ) premaincilly equivalent (for the indications
referenced above and have determined the device is substantially equivalent in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed president Device Amendments. for use stated in the enclosure) to tegally manced to health Device Amendments, or to
commerce prior to May 28, 1976, the enactives with the exceptions of the Federal Food. D commerce prior to May 28, 1976, the enactions of the Frosistions of the Federal Food, Drug, devices that have been reclassified in accordance with the provision of the Act. The Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject of the gentration listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mender requirements to the course of the successinst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mio existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to such additional controls: Listing may organ In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of reactal Regarations, This 2-7 ,
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualited of a substanter of the requirements of the Act
that FDA has made a determination that your device also Ferencies. You must that FDA has made a determination inalyou devices on other Federal agencies. You must
or any Federal statutes and regulations administed to: registration and listi or any Federal statutes and regulations and limited to: registration and listing (2)
comply with all the Act's requirements, including, but not be registration and listing (2 comply with all the Act s requirements, including, but not mining practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirem CFR Part 807); labeling (21 CFR Patl on (2) , good manara 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if appli forth in the quality systems (QS) regulation (21-51-143 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2-Sing-Hong Yeung
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin mailtoung your and equivalence of your device to a legally premarket notification: "The PDA mixing of castion 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), please If you uesn't specific advice for your acc (240) 276-0115. Also, please note the regulation entitled, Comaci the Office of Compuner an (= + notification" (21CFR Part 807.97). You may obtain Misorallums by relevence to premainterior in the Act from the Division of Small other general information on Jour response at its toll-free number (800) 638-2041 or Mallulacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Hyet Clurde
Miriam C. Provost, Ph.D.
am C. Provost, Ph.D. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
HES® Ultrasonic Therapy Appliance 510K Notification
INDICATIONS FOR USE
050410
510(k) Number (if known):
HES® Ultrasonic Therapy Appliance
Indications for Use:
Device Name:
A 22.0 4
The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styph Rurhm
(Division Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K050410