(275 days)
Not Found
Unknown
The device description mentions "intelligent and professional" operating modes, which could potentially involve AI/ML, but the summary provides no further details or evidence to confirm this. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described as a "Body Contouring Machine" intended for improving abdominal tone, strengthening muscles, and firming buttocks, thighs, and calves, which are therapeutic claims. It also references medical electrical equipment standards and biological evaluations, further indicating its use as a therapeutic device.
No
The device is described as a "non-invasive treatment device" for body contouring, strengthening, toning, and firming muscles. Its intended use focuses on physical improvement rather than diagnosis of a condition or disease.
No
The device description explicitly states it is a "non-invasive treatment device" that "generates an electromagnetic field" and is "equipped with four handles" and a "touch screen." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for body contouring and muscle strengthening/toning. This involves direct interaction with the human body to achieve physical changes.
- Device Description: The description details a non-invasive treatment device that generates an electromagnetic field to interact with human tissue. This is a physical interaction, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition. The focus is on therapeutic or aesthetic outcomes.
- Relevant Standards: The listed standards (IEC 60601 series, ISO 14971, ISO 10993 series) are typical for medical devices that interact with the body, not specifically for IVDs. While ISO 10993-5 mentions "in vitro cytotoxicity," this refers to testing the biocompatibility of the device materials, not the device's intended diagnostic function.
In summary, the Body Contouring Machine is a therapeutic or aesthetic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Body Contouring Machine can be used to:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms.
Product codes
NGX
Device Description
Body Contouring Machine is a non-invasive treatment device. The device generates an electromagnetic field that interacts with human tissue. Body Contouring Machine is equipped with four handles, two each for ZH-01 and ZH-03, which can treat different parts of the same time. The device is equipped with a 15.6-inch true-color touch screen and provides two operating modes, intelligent and professional, to meet the different needs of users.
The Body Contouring Machine includes seven models in this submission, CS2, CS3, CS5, CS7, CS8, CS11, and CS13, all seven models have same principle, software, operation etc., only differences are appearance
The subject device includes the following components:
- Handle: The handle is the working component of the treatment. Perform treatment according to the treatment parameters set by the host. Applied Model(s): CS2, CS3, CS5, CS7, CS8, CS11, CS13
- LCD screen: The device is equipped with a 15.6-inch true color touch screen. Applied Model(s): CS2, CS3, CS5, CS7, CS8, CS11, CS13
- Emergency stop switch: In an emergency, press this button to disconnect the control system and power supply, rotate it to the right and eject the button to return to normal. Applied Model(s): CS2, CS3, CS5, CS7, CS8, CS11, CS13
- Casters: Push the equipment horizontally to the designated position. Applied Model(s): CS2, CS3, CS5, CS7, CS8, CS11, CS13
- Push button switch: press this button under normal circumstances to open and close the control system and power supply. Applied Model(s): CS2, CS3, CS5, CS7, CS8, CS11, CS13
- Handle bracket: fixed treatment handle. Applied Model(s): CS2, CS3, CS5, CS7, CS8, CS11, CS13
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen, buttocks, thighs, calves, arms
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
- IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance:
- IEC 60601-1-2:2014+A1:2020, Medical electrical equipment- Part 1-2: General A requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
- IEC 60601-2-10:2012/AMD2:2023 Medical electrical equipment Part 2:Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
- IEC62304:2015, Medical device software – Software life cycle processes
- ISO 14971:2019. Medical devices Application of risk management to medical devices
- ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
- ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization
- Magnetic density test.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 24, 2024
Hebei JT Medical Co., Ltd. % Gina Lian General Manager Beijing STYH Medical Technology Service Co. Ltd. No.18, Jianshe Road, Kaixuan Street, Liangxiang Town, Fangshan District. Beijing, Beijing 102488 China
Re: K232181
Trade/Device Name: Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: August 7, 2023 Received: August 9, 2023
Dear Gina Lian:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tushar Bansal -S
2
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232181
Device Name
Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
Indications for Use (Describe)
Body Contouring Machine can be used to:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510k Summary K232181
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number:_ K232181
-
- Date of Preparation
8/7/2023
- Date of Preparation
-
- Sponsor
Hebei JT Medical Co., Ltd.
- Sponsor
C12 Hegu Industrial Park, Chaoyang Road, Development Zone ZhuoZhou city Establishment Registration Number: Not yet registered or the Number Contact Person: Karen Liu Position: Sales manager Tel: +86-13911459627 Fax:86-10-5721-2057 Email: 919309354@qq.com
-
- Submission Correspondent
Ms. Gina Lian
- Submission Correspondent
Beijing STYH Medical Technology Service Co. Ltd.
No.18, Jianshe Road, Kaixuan Street, Liangxiang Town, Fangshan District,102488 Beijing,China. Tel: +86-13311543099 Email: 409308721@qq.com
5
- Identification of Subject Device 4.
Trade Name: Body Contouring Machine
Common Name: Stimulator, muscle, powered, for muscle conditioning Model(s): CS2,CS3,CS5,CS7,CS8,CS11,CS13
Regulatory Information: Classification Name: Stimulator, muscle, powered, for muscle conditioning Classification: II; Product Code: NGX: Regulation Number: 21 CFR 890.5850 ; Review Panel: Physical Medicine ;
Indication for Use: Body Contouring Machine can be used to:
- ✔ Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- イ Strengthening, Toning and Firming of buttocks, thighs and calves.
- V Improvement of muscle tone and firmness, for strengthening muscles in arms.
-
- Device Description
Body Contouring Machine is a non-invasive treatment device. The device generates an electromagnetic field that interacts with human tissue. Body Contouring Machine is equipped with four handles, two each for ZH-01 and ZH-03, which can treat different parts of the same time. The device is equipped with a 15.6-inch true-color touch screen and provides two operating modes, intelligent and professional, to meet the different needs of users.
The Body Contouring Machine includes seven models in this submission, CS2,CS3,CS5,CS7, CS8,CS11, and CS13, all seven models have same principle, software, operation etc., only differences are appearance
The subject device includes the following components:
| Components | Function Description | Applied Model(s) |
|---|---|---|
| 1.Handle | The handle is the working component of the treatment. Perform treatment according to the treatment parameters set by the host. | CS2、CS3、CS5、CS7、CS8、CS11、CS13 |
| 2.LCD screen | The device is equipped with a 15.6-inch true color touch screen. | CS2、CS3、CS5、CS7、CS8、CS11、CS13 |
| 3.Emergency | In an emergency, press this button to disconnect the | CS2、CS3、CS5、CS7、 |
Table 1 Main Components of Subject Device
6
| stop switch | control system and power supply, rotate it to the right and eject the button to return to normal. | CS8、CS11、CS13 |
|---|---|---|
| 4.Casters | Push the equipment horizontally to the designated position | CS2、CS3、CS5、CS7、CS8、CS11、CS13 |
| 5.Push button switch | press this button under normal circumstances to open and close the control system and power supply | CS2、CS3、CS5、CS7、CS8、CS11、CS13 |
| 6.Handle bracket | fixed treatment handle | CS2、CS3、CS5、CS7、CS8、CS11、CS13 |
-
- Identification of Predicate Device
Predicate device 510(k) number: K190456 Trading name: BTL 799-2L Common name: Stimulator, muscle, powered, for muscle conditioning Regulation No.: 21 CFR 890.5850 Classification name: Stimulator, muscle, powered, for muscle conditioning Classification: Class II Product code: NGX
- Identification of Predicate Device
-
- Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
- Non-Clinical Test Conclusion
-
A IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance:
-
IEC 60601-1-2:2014+A1:2020, Medical electrical equipment- Part 1-2: General A requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
-
A IEC 60601-2-10:2012/AMD2:2023 Medical electrical equipment Part 2:Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
-
IEC62304:2015, Medical device software – Software life cycle processes
-
ISO 14971:2019. Medical devices Application of risk management to medical devices A
-
A ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and
7
testing within a risk management process
-
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro > cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation > and skin sensitization
-
Magnetic density test.
-
Clinical Test Conclusion 8.
No clinical study is included in this submission.
8
9. Substantially Equivalent (SE) Comparison
Table 2 General Comparison
| ITEM | Subject Device | Predicate Device |
|---|---|---|
| Product Code | NGX - Stimulator, Muscle, Powered, | |
| Muscle Conditioning | NGX - Stimulator, Muscle, Powered, | |
| Muscle Conditioning | ||
| Regulation | ||
| Number | 21 CFR 890.5850 | 21 CFR 890.5850 |
| Regulatory | ||
| Class | Class II | Class II |
| Clinical Use | Prescription use | Prescription use |
| Indication | ||
| for Use | Body Contouring Machine can be used to: | |
| ● Improvement of abdominal tone, | ||
| strengthening of the abdominal | ||
| muscles, development of firmer | ||
| abdomen. | ||
| ● Strengthening, Toning and Firming | ||
| of buttocks, thighs and calves. | ||
| ● Improvement of muscle tone and | ||
| firmness, for strengthening muscles | ||
| in arms. | BTL 799-2L is indicated to be used | |
| for: | ||
| ● Improvement of abdominal tone, | ||
| strengthening of the abdominal | ||
| muscles, development of firmer | ||
| abdomen. | ||
| ● Strengthening, Toning and | ||
| Firming of buttocks, thighs and | ||
| calves. | ||
| ● Improvement of muscle tone and | ||
| firmness, for strengthening | ||
| muscles in arms. | ||
| ITEM | Subject Device | Predicate Device |
| Principle of | ||
| Action | Initiating action potential of nerves results | |
| in muscle contraction | Initiating action potential of nerves | |
| results in muscle contraction. | ||
| Electrical | ||
| Protection | Class II, BF | Class II, BF |
| User Interface | Touch screen | Touch screen |
| Firmware | ||
| Controlled | Yes | Yes |
| Type of Energy | Magnetic field | Magnetic field |
| Number of | ||
| outputs | 4 | 2 |
| Number of | ||
| Magnetic Coils | ||
| in the | ||
| Applicator | 1 | 1 |
| Magnetic Field | ||
| Intensity | ZH-01 applicator: 0.1-1.8T±20% | BTL 299-6 applicator: 0.5 - 1.8 T |
| ±20% | ||
| ZH-03 applicator: 0.1-2.5T±20% | BTL 299-7 applicator: 0.7 - 2.0 T | |
| ±20% | ||
| Pulse | ||
| Repetition | ||
| Rate | 1-150Hz | 1 - 150 Hz |
| Pulse Duration | $300\pm20 \mu s$ |
$190\pm20 \mu s$ | BTL 299-6 applicator: $280 \pm 20% \mu s$
BTL 299-7 applicator: $190 \pm 20% \mu s$ |
| Selection of
parameters
(Intensity,
Time) | Yes | Yes |
| Therapy Time | Up to 60 min | Up to 60 min |
| Energy Source | 220/110V ,50 - 60 Hz | 100 - 240 V AC, 50 - 60 Hz |
| System
Dimensions
(W×H×D) | 4505301220mm | 580×1380×580 mm
(23×55×23 in) |
| Environmental
Specifications | For indoor use only | For indoor use only |
| Patient
Contacted Part | Skin | Skin |
9
Table 4 Safety Comparison
| Item | Subject Device | Predicate Device |
|---|---|---|
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1, IEC 60601-2-10 |
| Comply with IEC 60601-2-10 | Comply with IEC 60601-2-10 | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
Analysis:
These difference between the predicate devices and subject device have no significant influence on safety or effectiveness of the Body Contouring Machine.
The subject device is substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate device.