(41 days)
None
Not Found
No
The provided text describes a thermassage device with heating and massage functions for pain relief and circulation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes.
The device's intended use is to provide thermassage therapy for conditions like muscle and joint pain, stiffness, arthritis, and to increase local circulation, which are all therapeutic benefits.
No
The stated intended use focuses on providing therapy (heat and massage for temporary pain relief, circulation increase, and muscle relaxation), not on identifying or diagnosing a condition.
No
The intended use describes a "Thermassage Energy Product" that provides "heat and soothing massage" and "infrared lamps." These functions inherently require hardware components (heating elements, massage mechanisms, infrared emitters). The summary does not mention any software-only functionality.
Based on the provided information, the Migun Model HY-7000 Thermassage Energy Product is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that provides thermassage therapy, heat, and massage for the temporary relief of muscle and joint pain, stiffness, and to increase local circulation. These are all therapeutic and physical effects applied to the body, not diagnostic tests performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device's function is entirely external and therapeutic, aligning with a physical therapy or pain relief device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Migun Model HY-7000 Thermassage Energy Product is to provide thermassage therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for; - temporary relief of minor muscle and joint pain, and stiffness o - the temporary relief of minor joint pain associated with arthritis o - the temporary increase in local circulation where applied o - relaxation of muscles O
Product codes
JFB, ILY, ISA
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
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
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three stripes representing the department's mission to promote the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Migun Medical Instrument Co. Ltd. C/o Edward A. Kroll Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, Ohio 44141
Re: K041200
Trade/Device Name: HY7000 Thermassage Energy Product Trade/Device Name: 11117666 The S890.5800, 21 CFR §890.5500, 21 CFR §890.5660 Regulation Namber. 21 CPT 307011931521 therapy table, Infrared lamp, Therapeutic massager Regulatory Class: II Product Code: JFB, ILY, ISA Dated: April 30, 2004 Reccived: May 7, 2004
Dear Mr. Kroll:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) presidentially equivalent (for the indications referenced above and nave determined be a cases and see sparketed in interstate for use stated in the encrosule) to tegals actual date of the Medical Device American so to connineree prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been receassined in accessfired of a premarket approval application (PMA). alle Cosmetic Act (71ct) market the device, subject to the general controls provisions of the Act. The You may, merciole, market the act include requirements for annual registration, listing of gencial controls provisions of the rice, labeling, and prohibitions against 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 (soc world) als. Existing major regulations affecting your device can Inay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Possial 2013
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 Ficase be advised that I Dri- 3 issuation virus complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of any I edelai statures and regalanceds and limited to: registration and listing (21 Comply with an the Act 31equirements, 01); good manufacturing practice requirements as set CFN Fart 807), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulantin (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maining of substantial equivalence of your device to a legally premarket notification: The Presification 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 desire specific arreliance at (301) 594-4659. Also, please note the regulation entitled, Comact the Office of Company of Company (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark Melkerson
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K041200
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The intended use of the Migun Model HY-7000 Thermassage Energy Product is to The finchica use of the Migar Product n therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;
- temporary relief of minor muscle and joint pain, and stiffness o
- the temporary relief of minor joint pain associated with arthritis 0
- the temporary increase in local circulation where applied 0
- relaxation of muscles O
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Center for Devices and Radiological Health / CDRH
Page _ of _
Mark A. Milken
Division of General, Restorative, and Neurological Devices
12041200
510(k) Number____