(322 days)
Not Found
No
The description focuses on mechanical and thermal functions (motorized carriages, infrared lights, heat, massage) and does not mention any computational or adaptive elements typically associated with AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
Yes
The device is described as providing "muscle relaxation therapy by delivering heat and soothing massage," which directly addresses a health-related condition, classifying it as therapeutic.
No
The device provides muscle relaxation therapy through heat and massage, which are therapeutic functions, not diagnostic ones. Diagnostics involve identifying a disease or condition.
No
The device description clearly states it is an "electrically powered, motorized multi-functional physical therapy table" with "two independent carriages" and "five infrared lights," indicating it is a hardware device.
Based on the provided information, the CHOYANG Thermal Massager (Model: CY-7000) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "to provide patients with muscle relaxation therapy by delivering heat and soothing massage." This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a physical therapy table that applies heat and massage to the body. This aligns with a physical therapy or therapeutic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through laboratory tests, or providing information for diagnosis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The CHOYANG Thermal Massager does not fit this description.
N/A
Intended Use / Indications for Use
The intended use of the CHOYANG Thermal Massager (Model: CY-7000) is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.
Product codes (comma separated list FDA assigned to the subject device)
JFB, ISA
Device Description
The CHOYANG Thermal Massager (Model: CY-7000) is an electrically powered, motorized multi-functional physical therapy table. It is intended function and use is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by way of two independent carriages. Each carriage has five infrared lights. During use, these carriages traverse from lower torso to upper torso and apply light pressure as well as heat to the supine user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower torso to upper torso (implied)
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)
The compliance of the CHOYANG Thermal Massager (Model: CY-7000) has been satisfied with the applicable requirements of the EN 60601-1-2. The tests have been performed by SGS Testing Korea.
The results of bench and clinical evaluation indicate that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows a logo with the word "CHOYANG" in a stylized font. The word is positioned to the right of a curved, swooping shape that resembles a crescent or an arc. The logo is set against a white background, and the text and shape are in black.
MAY 2 5 2012
Exhibit 5 510(k) Summary
CHOYANG Thermal Massager (Model: CY-7000)
-
- Submitter and US Official Correspondent
| Submitter: | Choyang Medical Instrument Co., Ltd. |
|---|---|
| Address: | 66-3 Yogwang-ri, Chubu-myeon, Geumsan-gun |
| Chungcheongnam-do, 312-943, Korea | |
| Tel: +82-41-754-8070~3 | |
| Fax: +82-41-754-8075 | |
| Contact: Jung Hyun, Quality Assurance Manager | |
| Email: jh0158@nate.com |
| US Official Correspondent: | Shin Kuk Yoo, Consultant |
|---|---|
| Telephone No.: | 714-313-7442 |
| Fax No.: | 8 01-303-7455 |
| Email: | skyone@LSKBioPartners.com |
2. Establishment Registration Number
The firm will be registered and listed prior to distribution of medical device in United States.
3. Device Information
| Proprietary/Trade Name: | CHOYANG Thermal Massager (Model: CY-7000) |
|---|---|
| Common/Usual Name: | Multi-function physical therapy table, Therapeutic massager |
| Classification Name: | Table, Physical therapy, Multi-function |
| Product Code: | JFB |
| Subsequent Product Code: | ISA |
| Device Class: | Class II per regulation 21 CFR 890.5880, 21 CFR 890.5660 |
4. New or modification
:
This notification is for a new device for the USA market.
12
1
5. Equivalent Legally Marketed Device
| Predicate #1 | |
|---|---|
| Manufacturer: | Migun Medical Instrument Co., Ltd. |
| Device Name: | HY7000 Thermassage Energy Product |
| 510(k) Number: | K041200 (Decision Date - June 17, 2004) |
| Classification: | Table, Physical Therapy, Multi Function |
| JFB (Classification Product Code) | |
| Class II per regulation 21 CFR 890.5880 |
Predicate #2
| Manufacturer: | CERAGEM Co., Ltd. |
|---|---|
| Device Name: | CERAGEM-RH1 Automatic Thermal Massager |
| 510(k) Number: | K062476 (Decision Date - Oct. 31, 2006) |
| Classification: | Table, Physical Therapy, Multi Function |
| JFB (Classification Product Code) | |
| Class II per regulation 21 CFR 890.5880 |
ଚ. Description of the Device
The CHOYANG Thermal Massager (Model: CY-7000) is an electrically powe red, motorized multi-functional physical therapy table. It is intended function and use is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by way of two independent carriages. Each carriage has five infrared lights. During use, these carriages traverse from lower torso to upper torso and apply light pressure as well as heat to the supine user.
7. Indications for use
The intended use of the CHOYANG Thermal Massager (Model: CY-7000) is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.
8. Safety, EMC and Performance Data
The compliance of the CHOYANG Thermal Massager (Model: CY-7000) has been satisfied with the applicable requirements of the EN 60601-1-2. The tests have been performed by SGS Testing Korea.
16
2
9. Safety and Effectiveness, comparison to Predicate
The results of bench and clinical evaluation indicate that the new device is as safe and effective as the predicate devices.
10. Substantial Equivalence Chart
.
| No | Item | CHOYANG Thermal
Massager | HY7000 Thermassage
Energy Product | Ceragem-RH1 Automatic
Massager |
|----|----------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 1 | 510K Number | None | K041200 | K062476 |
| 2 | Manufacturer | Choyang Medical
Instrument Co., Ltd. | Migun Medical
Instrument Co., Ltd. | CERAGEM Co., Ltd. |
| 3 | Regulation Number | CFR 890.5880, | CFR 890.5880, | CFR 890.5880, |
| 4 | Product code | JFB, ISA | JFB, ISA, ILY | JFB, ISA, ILY |
| 5 | Classification | Class II
(21CFR 890.5880) | Class II
(21CFR 890.5880) | Class II
(21CFR 890.5880) |
| 6 | Rated input voltage | 120V a.c | 120V a.c | 120V a.c |
| 7 | Supply Frequency | 50-60Hz | 50Hz | 60Hz |
| 8 | Rated input power | 250W | 269W | 290W |
| 9 | Degree of protection | Type BF applied part | Type BF applied part | Type BF applied part |
| 10 | Ambient temperature | 4070℃ | 4070℃ | 30~60℃ |
| 11 | Weight | 64Kg | 74Kg | 87Kg |
| 12 | Safe working load | Max. 150Kg | Max. 150Kg | Max. 140Kg |
| 13 | Massage roller | Jade | Geranium Cerramic | Jade |
| 14 | Mode Set-Up | Auto Mode
Semi-Auto Mode | Auto Mode
Semi-Auto Mode | Auto Mode
Semi-Auto Mode |
| 15 | Remote Buttons | Rubber Pad Type | Rubber Pad Type | Rubber Pad Type |
| 16 | Operating time | 36min | 34min | 40min |
| 17 | Intended Use | The intended use of the
CHOYANG Thermal
Massager is to provide
patients with muscle | The intended use of the device is to provide patients
with muscle relaxation therapy by delivering heat and
soothing massage. Additionally, the infrared lamps
provide topical heating for; | |
| | relaxation | therapy by | | - temporary relief of minor muscle and joint pain and |
| | delivering | heat and | | stiffness |
| | soothing massage. | | | - the temporary relief of minor joint pain associated |
| | | | | with arthritis |
| | | | | - the temporary increase in local circulation where |
| | | | | applied |
| | | | | - relaxation of muscle |
3
11. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided the above comparison table, the Choyang Medical Instrument Co., Ltd. concludes that the CHOYANG Thermal Massager (Model: CY-7000) is safe and effective and substantially equivalent to the predicate devices as described above.
18
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes that resemble human figures or elements of a design. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 25 2012
Choyang Medical Instrument Co., Ltd. % LSK BioPartners, Inc. Mr. Shin Kuk Yoo 8 East Broadway, Suite 611 Salt Lake City, Utah 84111
Re: K11941
Trade/Device Name: Choyang Thermal Massager (Model: CY-7000) Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-function physical therapy table Regulatory Class: Class II Product Code: JFB Dated: May 15, 2012 Received: May 17, 2012
Dear Mr. Shin Kuk Yoo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
5
Page 2 - Mr. Shin Kuk Yoo
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Euil Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Exhibit 4 Indications for Use
510(k) number (if known):
K111994
Device Name: CHOYANG Thermal Massager (Model: CY-7000)
Indications for Use:
The intended use of the CHOYANG Thermal Massager (Model: CY-7000) is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vernon H. Clark
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111941