Powered Muscle Stimulator (Model name:MagGraver F200)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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. March 9, 2023 Nanjing Vishee Medical Technology Co., Ltd. Lisa Tan Regulatory Affairs Building 9, No. 19, Ningshuang Road Yuhuatai District Nanjing, Jiangsu 210012 China Re: K222875 Trade/Device Name: Powered Muscle Stimulator (Model name: MagGraver F200) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: September 15, 2022 Received: September 22, 2022 Dear Lisa Tan: 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. 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 located 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 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222875 #### Device Name Powered Muscle Stimulator (Model name:MagGraver F200) Indications for Use (Describe) Powered Muscle Stimulator (Model name:MagGraver F200) 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. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |----------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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." {3}------------------------------------------------ # 510(K) Summary Prepared in accordance with the requirements of 21 CFR Part 807.92 ### Prepared Date: March 08,2023 1. Submitter's Information #### OFFICIAL CORRESPONDENT | Name: | Nanjing Vishee Medical Technology Co., Ltd. | |-----------------|----------------------------------------------------------------| | Address: | Building 9, No.19, Ningshuang Road, Yuhuatai District,Nanjing, | | | Jiangsu 210012 China | | Contact person: | Lisa TAN | | Title: | Regulatory Affairs | | E-mail: | tanyumei@vishee.com | | Tel: | +86-025-69670888#7629 | #### APPLICANT | Name: | Nanjing Vishee Medical Technology Co., Ltd. | |-----------------|----------------------------------------------------------------| | Address: | Building 9, No.19, Ningshuang Road, Yuhuatai District,Nanjing, | | | Jiangsu 210012 China | | Contact person: | Kai QIU | | Title: | Director of research and development department | | E-mail: | qiukai@vishee.com | | Tel: | +86-025-69670888#8078 | # 2. Device Identification | 510(K) number: | K222875 | |--------------------|------------------------------------------------------| | Trade/Device Name: | Powered Muscle Stimulator | | Models: | MagGraver F200 | | Common name: | Stimulator, Muscle, Powered, For Muscle Conditioning | | Regulation Number: | 21 CFR 890.5850 | | Regulation Name: | Stimulator, Muscle, Powered, For Muscle Conditioning | | Regulation Class: | Class 2 | | Panel: | Physical Medicine | | Product Code: | NGX | # 3. Predicate Device | 510(K) number: | K180813 | |----------------|------------------------------------------------------| | Device Name: | BTL 799-2 | | Manufacturer: | BTL Industries, Inc. | | Common name | Stimulator, Muscle, Powered, For Muscle Conditioning | {4}------------------------------------------------ | Regulation Number: | 21 CFR 890.5850 | |--------------------|------------------------------------------------------| | Regulation Name: | Stimulator, Muscle, Powered, For Muscle Conditioning | | Regulation Class: | Class 2 | | Panel: | Physical Medicine | | Product Code: | NGX | #### 4. Indication for Use Powered Muscle Stimulator (Model name:MagGraver F200) 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. #### 5. Device Description Powered Muscle Stimulator (Model name:MagGraver F200) is a non-invasive therapeutic device. The device produces electromagnetic field that stimulates the tissues of the human body, the device helps to strengthen, tone, and firm the abdomen and buttocks by stimulating muscle. The device has two output channels and two applicators, one applicator (Form A) is applicable for abdomen and another (Form B) is applicable for buttocks. The applicator can plug in either output channels. The two outputs of device enable simultaneous treatment by two applicators. The Form A applicator consists of round coil and cooling system. The Form B applicator consists of figure-of-eight coil and cooling system. There is a pressure kit is used to monitor abdomen muscle contraction by monitor the pressure between applicator and abdomen, the pressure kit is only used with Form A applicator. The device is equipped with a color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The screen angle can be adjusted. {5}------------------------------------------------ Image /page/5/Figure/0 description: The image contains two figures showing the front and right side of a powered muscle stimulator. Figure 1 shows the front of the stimulator and labels the applicators (1), applicator holder hook (2), touch screen (3), indicator light (4), power button (5), trademark (6), and castors (7). Figure 2 shows the right side of the stimulator and labels the applicators (1), applicator holder hook (2), and emergency button (8). {6}------------------------------------------------ Image /page/6/Figure/0 description: The image contains two figures, Figure 3 and Figure 4. Figure 3 shows the back of a powered muscle stimulator with labels 9 through 19 indicating different parts such as the handrail, pressure kit interface, fuse socket, main switch, power inlet, USB port, network interface, applicator interface, and ventilation grid. Figure 4 shows applicators, with labels 20, 21, and 22 indicating the spring lock latch, applicator (Form A), and applicator (Form B) respectively. {7}------------------------------------------------ Image /page/7/Figure/0 description: This image shows a pressure kit, labeled as Figure 5. The kit includes a pressure airbag (23), a pressure control device (24), a snap lock (button-type) (25), and an air hose (26). The image shows two different arrangements of the kit components, with the pressure airbag and control device connected by tubing. ## 6. Compared to Predicate Device Compared to the predicate devices, the subject device has the similar intended use, similar product design, similar performance, same safety as the predicate device, the summarized comparison information is listed in the following table | SE<br>Comparisons | Subject Device<br>Powered Muscle Stimulator<br>(Model name:MagGraver<br>F200) (K222875) | Primary Predicate Device<br>BTL 799-2 (K180813) | Similarities/<br>Differences | |-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Indication for<br>Use | Powered Muscle Stimulator<br>(Model name:MagGraver<br>F200) is indicated to be used<br>for:<br>• Improvement of abdominal<br>tone, strengthening of the<br>abdominal muscles,<br>development of firmer<br>abdomen.<br>• Strengthening, Toning and<br>Firming of buttocks. | BTL 799-2 is indicated to be<br>used for:<br>• Improvement of abdominal<br>tone, strengthening of the<br>abdominal muscles,<br>development of firmer abdomen.<br>• Strengthening, Toning and<br>Firming of buttocks and thighs. | See Note 1 | | Product code | NGX | NGX | Same | | Class | II | II | Same | | Principle of<br>Action | Initiating action potential of<br>nerves results in muscle<br>contraction | Initiating action potential of<br>nerves results in muscle<br>contraction | Same | | Clinical Use | Prescription use | Prescription use | Same | | User Interface | Touch screen | Touch screen | Same | | Type of Energy | Magnetic field | Magnetic field | Same | | SE<br>Comparisons | Subject Device<br>Powered Muscle Stimulator<br>(Model name:MagGraver<br>F200) (K222875) | Primary Predicate Device<br>BTL 799-2 (K180813) | Similarities/<br>Differences | | Number of<br>outputs | 2 | 2 | Same | | Number of<br>Magnetic Coils<br>in the<br>Applicator | 1 | 1 | Same | | Magnetic Field<br>Intensity | Form A applicator: 0–1.8 T<br>Form B applicator: 0–1.8 T | 299-6 applicator: 0.5-1.8 T | Note 2 | | Pulse<br>Repetition<br>Rate | 1-150Hz | 1-150Hz | Same | | Pulse Duration | 340 µs ±20 µs | 280±20% µs | Note 3 | | Pulse<br>Amplitude | 0-100% | 0-100% | Same | | Selection of<br>parameters<br>(Intensity,<br>Time) | YES | YES | Same | | Therapy Time | Up to 36 min | Up to 60 min | Note 4 | | Power rate | 100-240 VAC,50-60Hz, 2.5kVA | 100-240 VAC, 50-60 Hz,2800W | Note 5 | | System<br>Dimensions<br>(W×H×D) | 576 (L) × 669 (W) × 1100 (H)<br>mm | 500×1380×580 mm<br>(20×55×23 in) | Note 5 | | Operation<br>condition | +5°C to +28°C<br>≤ 80% RH<br>860hPa to 1060hPa | +10°C to +30°C<br>30% to 75% RH<br>700hPa to 1060hPa | Note 5 | | Transport and<br>storage<br>conditions | -20°C to +55°C<br>≤ 80% RH<br>860 hPa to 1060 hPa | -10°C to +55 °C<br>10% to 85% RH<br>650 hPa to 1100 hPa | Note 6 | | Environmental<br>Specifications | For indoor use only | For indoor use only | Same | {8}------------------------------------------------ Note 1: The proposed device is not intended use for thighs. Note 2: The Magnetic Field Intensity of subject device is 0-1.8T, no new risk arises. Note 3: There have been theoretical studies presented that only relatively small variations in the average recruited nerve fiber diameter of approximately 1 µ m were observed in the experimental study, when the stimulus pulse width was increased from 50 µ s to 500 µ s. The theoretical prediction of the relatively small variation in motor nerve fiber recruitment patterns coupled with consistent experimental evidence suggests that there is little potential for achieving significant motor nerve fiber {9}------------------------------------------------ recruitment selectivity by varying the stimulus pulse width over the clinically useful range of 50 µ s to 500 µ s when surface stimulation is used [1]. The pulse width of the subject device and the predicate device are in the typical clinical range of 50 to 500 µs, the difference will not affect product safety and performance. Note 4: The treatment of proposed device is between 0~36 min, it is less than subject device. The high temperature risk is lower than predicate device. Note 5: The subject device complies with IEC 60601-1: 2005+A1:2012, no energy risk and mechanical risk arise. And the subject device can be operation conditions manufacture specified. Note 6: We conducted simulate transportation tests, the subject device can be transported and stored in transport and storage conditions manufacture specified. The subject device and predicate devices are substantially equivalent in the areas of technological characteristics such as basic design, features, energy source, method of operation, general function, application, and intended use. The subject device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. #### 8. Performance Data #### Clinical test: Clinical testing is not required. #### Non-clinical data #### -Safety IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. IEC 60601-2-10:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators #### -EMC IEC 60601-1-2:2014 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic Disturbances-Requirements and tests - -Biocompatibility ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization [1] Szlavik RB, de Bruin H. The effect of stimulus current pulse width on nerve fiber size recruitment patterns. Med Eng Phys. 1999 Jul-Sep;21(6-7):507-15. doi: 10.1016/s1350-4533(99)00074-0. PMID: 10624746 {10}------------------------------------------------ ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation -Shelf life Internal test method. -Simulated transportation ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems -Software Verification and Validation: Software 2021 draft Content of Premarket Submissions for Premarket-Software-Functions-Guidance #### Performance Testing: -Bench Testing a.Take the center of the applicator as the starting point (0, 0, 0), and the distance between each target point is 10mm, measure the pulse waveform of the target point. The X-axis of Form A has a range of [-120, 120], the Y-axis has a range of [-80, 80], and the Z-axis has a range of [0, 50]. The X-axis of Form B has a range of [-80, 80] for each side of figure 8 coil, the Y-axis has a range of [-80, 80], and the Z-axis has a range of [0, 50], as shown below. Record the maximum magnetic induction intensity at each point and save the pulse waveform. The measured data was mapped into a three-dimensional magnetic field distribution map with F-30 multi-dimensional magnetic field analysis system manufactured by CH-Maqnetoelectricity Technology. Image /page/10/Figure/9 description: The image contains text describing test results. The text states that the dB/dt is 34.04KT/s. It also mentions that the magnetic field mapping can be seen in the photo below. Image /page/10/Figure/10 description: The image contains two 3D plots showing the magnetic field distribution of two different forms, labeled A and B. Each plot displays the magnetic field strength using a color scale ranging from blue to red, with red indicating higher field strength. Form A's distribution appears to have a single, concentrated area of high magnetic field, while Form B exhibits multiple areas of high magnetic field strength. The plots also include axes labeled X/mm, Y/mm, and Z/mm, providing spatial context for the magnetic field distribution. b. Applied to the stimulation applicator, the Tesla meter probe is placed vertically on the central position surface of the stimulation applicator, and the maximum value measured is the maximum magnetic induction intensity of the stimulation applicator. The test results show Form A applicator Maqnetic Intensity is 1.8T.Form B applicator Magnetic Intensity is 1.8T. #### 9. Conclusion 510(k) Summary {11}------------------------------------------------ The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device (K180813).