(41 days)
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
Not Found
The provided document is a 510(k) clearance letter from the FDA to Migun Medical Instrument Co. Ltd. for their HY7000 Thermassage Energy Product. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.
FDA 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new studies proving specific performance criteria against predefined thresholds. The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications referenced above and as described in the enclosure) to legally marketed predicate devices."
Therefore, I cannot extract the requested information (table of acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document because it is not present. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with explicit acceptance criteria for the new device.
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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.
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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
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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____
§ 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).