I-Motion

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration". May 26, 2022 I-Motion Group Global Iberica S.L. Jose Soto Belloso Managing Director Calle Loeches 66.8 CP Alcorcon, Madrid 28925 Spain Re: K212413 Trade/Device Name: I-Motion, I-Motion Fit Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: April 25, 2022 Received: April 26, 2022 Dear Jose Soto Belloso: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 mediation-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, 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 Quality Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212413 Device Name I-Motion I-Motion Fit #### Indications for Use (Describe) I-MOTION intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The I-MOTION is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contra indicated. I-MOTION is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes. I-MOTION electrical impulses allow the triggering o faction potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor end plate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------|-----------------------------------------------------------| | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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. 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INFORMATION | DATE OF SUBMISSION: | 2021-April-01 | |----------------------|---------------------------------------------------------------------------| | SUBMITTER NAME: | I-MOTION GROUP GLOBAL IBERICA S.L. | | SUBMITTER ADDRESS: | Calle Loeches 66.8<br>28925-Alcorcón, Madrid<br>SPAIN | | CONTACT: | Jose Luis Soto Belloso | | TELEPHONE: | +34 914 93 88 45 | | e-mail: | jl.soto@i-motion.es | | DEVICE TRADE NAME: | I-Motion, I-Motion Fit | | COMMON NAME: | Powered muscle stimulator. | | CLASSIFICATION NAME: | Stimulator, Muscle, Powered, For Muscle Conditioning<br>(21 CFR 890.5850) | | PREDICATE DEVICE(S): | WIEMSpro (K181955) | ## 2. DEVICE DESCRIPTION The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances. None of I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. I-MOTION is a device for electronic muscle stimulation based on EMS technology. As for its use, the device is specifically designed as a complement to other sports and to train muscles. It must be used only for healthy muscles and clients, not for rehabilitation purposes. The device must be worn over the user's cotton underwear, the electrodes do not come into direct contact with the client. The I-MOTION System cannot be used while the user is moving or lifting weights. {4}------------------------------------------------ ## 3. SUMMARY OF COMPARISON WITH PREDICATE DEVICE In the establishment of substantial equivalence, the I-Motion device is compared with the following previously cleared devices: - WiEMSpro (K181955) Comparison of the proposed devices with the predicate devices is summarized in the following table: | COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic<br>/ Feature | PROPOSED DEVICE<br>I-Motion | PREDICATE DEVICE<br>WIEMSpro | Comparison | | | | GENERAL COMPARISON | | | | | Classification<br>name | Powered muscle stimulator | Powered muscle stimulator | Same | | | Product code | NGX | NGX | Same | | | Regulation<br>number | 21 CFR 890.5850 | 21 CFR 890.5850 | Same | | | Panel | Physical Medicine | Physical Medicine | Same | | | Class | Class II | Class II | Same | | | 510(K)<br>Number | -- | K181955 | N/A | | | | INTENDED USE | | | | | Intended use | Must be used for only healthy<br>muscles and client. It is not intended<br>to be used in conjunction with<br>therapy or treatment of medical<br>conditions of any kind. | Must be used for only healthy muscles<br>and client. It is not intended to be used<br>in conjunction with therapy or treatment<br>of medical diseases or medical<br>conditions of any kind.. | Same | | | Indications<br>for use | I-MOTION is intended to stimulate<br>healthy muscles in order to<br>improve or facilitate muscle<br>performance, is not intended to be<br>used in conjunction with therapy or<br>treatment of medical diseases or<br>medical conditions of any kind.<br>None of I-MOTION training<br>programs is designed for injured or<br>ailing muscles and its use on such<br>muscles is contraindicated.<br>Each of the I-MOTION training<br>programs depending on the<br>parameters of the electrical<br>impulses (pulse frequency,<br>duration of contraction, duration of<br>rest, total session duration),<br>different types of muscle work can<br>be imposed on the stimulated<br>muscles.<br>I-MOTION is a machine with<br>electronic muscle stimulation<br>based on EMS technology.<br>Regarding its use, I-MOTION is<br>specifically designed as an<br>addition to other sports and for<br>training muscles. It must be used | WIEMSPRO is intended to stimulate<br>healthy muscles in order to improve or<br>facilitate muscle performance. The<br>WIEMSPRO is not intended to be used<br>in conjunction with therapy or treatment<br>of medical diseases or medical<br>conditions of any kind. None of<br>WIEMSPRO training programs is<br>designed for injured or ailing muscles<br>and its use on such muscles is<br>contraindicated.<br>WIEMSPRO is a machine with<br>electronic muscle stimulation based on<br>EMS technology.<br>Regarding its use, the device is<br>specifically designed as an addition to<br>other sports and for training muscles. It<br>must be used for only healthy muscles<br>and clients, not for rehabilitation<br>purposes.<br>WIEMSPRO electrical impulses allow<br>the triggering of action potentials on<br>motoneurones of motor nerves<br>(excitations).<br>These excitations of motoneurones are<br>transmitted to the muscle fibers via the<br>motor endplate where they generate | Similar.<br>Difference is the<br>Software application<br>which controls the<br>device, not affecting the<br>safety, efficiency, or<br>functionality of the<br>device. | | | I-MOTION GROUP<br>GLOBAL IBERICA | | | 510(k) Premarket Notification | Image: i-motion logo | | | 510(k) SUMMARY | | | | | | rehabilitation purposes. | | correspond to muscle work.<br>Depending on the parameters of the<br>electrical impulses (pulse frequency,<br>duration of contraction, duration of rest,<br>total session duration), different types<br>of muscle work can be imposed on the<br>stimulated muscles. | | | Prescription/<br>Rx | Prescription only | | Prescription only | Same | | Use<br>environment | Use in athletic training facilities. Not<br>for use outdoors | | Use in athletic training<br>facilities. Not for use<br>outdoors | Same | | Anatomical<br>sites | Electrodes can be applied to<br>multiple anatomical sites. | | Electrodes can be applied<br>to multiple anatomical<br>sites. | Same | | | TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE | | | | | Powered<br>Muscle<br>Stimulator | YES | YES | | Same | | Power<br>Source | | Battery:2 x 3.7 V= 7,4V<br>- 3,4AH (Lithium) | Battery:3.7V-2,4AH (LiPo) | Similar<br>Minimal differences in the<br>technical<br>characteristic/performance,<br>not affecting the safety,<br>efficiency, or functionality<br>of the device | | I-MOTION GROUP<br>GLOBAL IBERICA | 510(k) Premarket Notification | | Image: imotion logo | | | 510(k) SUMMARY | | | | | | Method of line<br>current<br>isolation | N/A (battery operated device) | N/A (battery operated device) | Same | | | Patient leakage<br>current<br>-Normal<br>condition<br>-Single fault<br>condition | N/A (battery operated device)<br>N/A (battery operated device) | N/A (battery operated device)<br>N/A (battery operated device) | Same | | | Battery operated | YES, lithium polymer cell<br>rechargeable | YES, lithium polymer cell<br>rechargeable | Same | | | Number of<br>Output modes | One output mode, but with varying<br>stimulation frequency and duty<br>cycle ranges | One output mode, but with<br>varying stimulation<br>frequency and duty cycle<br>ranges | Same | | | Number of<br>Output channels<br>- Synchronous or<br>Alternating?<br>-Method of Channel<br>Isolation | 1 CHANNEL<br>Alternating | 1 CHANNEL<br>Alternating | Same | | | Independent<br>channels with<br>possibility to<br>regulate the<br>current<br>individually | 10 CHANNELS…