Who is the manufacturer of StarFormer (M008-3T)?

Fotona D.O.O. filed the 510(k) submission for StarFormer (M008-3T) (K241785).

What is the FDA product code for StarFormer (M008-3T)?

QPL. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for StarFormer (M008-3T)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for StarFormer (M008-3T)?

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption (K230014); Hi-Dow Wireless TENS/EMS System (Model HD-SN) (K163393); StarFormer (K221274).

Who can help prepare an FDA 510(k) submission like StarFormer (M008-3T)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

StarFormer (M008-3T)

K241785 · Fotona D.O.O. · QPL · Mar 27, 2025 · Neurology

Device Facts

Record ID	K241785
Device Name	StarFormer (M008-3T)
Applicant	Fotona D.O.O.
Product Code	QPL · Neurology
Decision Date	Mar 27, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2
Attributes	Therapeutic

Intended Use

With handheld applicators: PMS mode: Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance. Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation. TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. With Chair Back applicator: TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities.

Device Story

Non-invasive therapeutic device; utilizes magnetic stimulation coils in handheld applicators and chair backrest. System controller sends alternating electric current to coils; generates rapidly changing magnetic waves propagating into tissue; induces secondary electric current to stimulate nerves and muscles. Used in hospitals and clinics under physician supervision. Provides muscle conditioning (PMS mode) and peripheral nerve stimulation (TENS mode). Output controlled via touchscreen GUI. Benefits include muscle performance improvement, disuse atrophy prevention, and pain relief. Device includes system controller, high-voltage power supply, applicators, and chair.

Clinical Evidence

No clinical data; bench testing only. Performance established via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software verification/validation, cybersecurity testing, and magnetic field strength bench testing.

Technological Characteristics

Magnetic stimulation device; 100-240V AC power; 1.8T magnetic field intensity; 1-80 Hz pulse repetition rate; 330 µs pulse width; biphasic sine waveform. Touchscreen interface. Complies with IEC 60601-1, IEC 60601-1-2, ISO 14971, and IEC 62304. Software-controlled via microprocessor.

Indications for Use

Indicated for muscle conditioning, neuromuscular tissue stimulation for bulk muscle excitation (arms, legs, buttocks, thighs), prevention of disuse atrophy, and increasing local blood circulation in patients under medical supervision. Also indicated for TENS-based relief of chronic intractable, post-traumatic, and post-surgical pain, and temporary relief of muscle soreness/aching (shoulder, waist, back, extremities) in patients 18 years or older.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption (K230014)
Hi-Dow Wireless TENS/EMS System (Model HD-SN) (K163393)
StarFormer (K221274)

Related Devices

K221274 — StarFormer, TightWave · Fotona D.O.O. · Sep 29, 2023
K190456 — BTL 799-2L · BTL Industries, Inc. · Jul 5, 2019
K203710 — Storz Medical MAGNETOLITH Muscle Stimulator · Storz Medical AG · May 3, 2021
K160992 — HPM-6000 · BTL Industries, Inc. · Oct 21, 2016
K203488 — emField · Zimmer Medizinsysteme GmbH · Feb 19, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ March 27, 2025 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue. Fotona d.o.o. Tina Bartolic Quality Assurance and Regulatory Affairs Specialist Stegne 7 Ljubljana, Slovenia Re: K241785 Trade/Device Name: StarFormer (M008-3T) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: QPL, IPF, NGX Dated: June 20, 2024 Received: June 20, 2024 Dear Tina Bartolic: 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-regulatory {2}------------------------------------------------ assistance/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, # Amber T. Ballard -S Amber Ballard, PhD Assistant Director 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 Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241785 Device Name StarFormer (M008-3T) #### Indications for Use (Describe) • With handheld applicators: PMS mode: Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance. Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation. TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. · With Chair Back applicator: TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities. Type of Use (Select one or both, as applicable) X 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}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, light gray font. There is a red circle to the right of the word "Fotona". Fotona Stegne 7, 1000 Ljubljana, Slovenia t. +386 (0)1 500 91 00 f. +386 (0)1 500 92 00 www.fotona.com Image /page/4/Picture/2 description: The image contains several logos and text. At the top is a TÜV Product Service logo with ISO 9001 and ISO 13485 certifications. Below that, it says "founding member: FOTONIKA 21" with a logo. At the bottom, it says "competency center" and "biomedical engineering" with a cube-like logo in between. ## TRADITIONAL 510(K) SUMMARY | 1. SUBMITTER INFORMATION | | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant & Official Correspondent | Ms. Tina Bartolic Quality Assurance and Regulatory Affairs Specialist Fotona d.o.o. Stegne 7, Ljublijana, Slovenia +38615009100 tina.bartolic@fotona.com | | Date Prepared | September 13, 2024 | | 2. DEVICE NAME | | | Trade Name of the Device | StarFormer | | Common Name: | StarFormer | | Classification Name: | Transcutaneous electrical nerve stimulator for pain relief | | Classification Regulation: | 882.5890 | | Device Class: | II | | Product Code: | QPL Associated Product Code(s): IPF, NGX | | Panel: | Neurology | | 3. PREDICATE DEVICEIDENTIFICATION | K230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption K163393 Hi-Dow Wireless TENS/EMS System (Model HD-SN) K221274 StarFormer | | 4. DEVICE DESCRIPTION: | StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the handheld applicators and in the back of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current. This current stimulates neurons and activates muscle contractions. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply, handheld applicators and a chair. | | 5. INDICATIONS FOR USE: | With handheld applicators: PMS mode: Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, light gray sans-serif font. To the right of the word "Fotona" is a red circle. Fotona tegne 7, 1000 Ljubliana, Slove 386 (0)1 500 91 00 386 (0)1 500 92 00 ww.fotona.com Image /page/5/Picture/3 description: The image shows a logo with the text "TUV PRODUCT SERVICE" inside an octagon shape. Below the logo, the text "ISO 9001" and "ISO 13485" are written on either side of the octagon. Further down, the text "founding member: FOTONIKA 21" is displayed, along with the words "competency center" and "biomedical engineering". including abdomen muscles in order to improve or facilitate muscle performance. Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation. TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. With Chair Back applicator: TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and postsurgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities. 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a light gray sans-serif font. To the right of the word "Fotona" is a red circle. Image /page/6/Picture/7 description: The image shows a gray octagon with the text "TUV PRODUCT SERVICE" in the center. The octagon also contains the text "ISO 9001" on the left and "ISO 13485" on the right. At the top of the octagon is a recycling symbol. Fotona Stegne 7, 1000 Ljubljana, Slovenia t. +386 (0)1 500 91 00 f. +386 (0)1 500 92 00 dina me OOOFOTONIKA 21 competency biomedical | f. +386 (0)1 500 92 00 www.fotona.com | | | | | | | | | | | | |------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Manufacturer | Fotona d.o.o. | Tonica Elektronik A/S | Hi-Dow Electron Technology (Hefei) Inc., Ltd. | Fotona d.o.o | | | | | | | | | Device name | StarFormer | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | Hi-Dow Wireless TENS/EMS (Model HD- 5N) | StarFormer | SE determination | | | | | | | | 510 (k) number | SUBJECT DEVICE K241785 | PREDICATE DEVICE 1 K230014 | PREDICATE DEVICE 2 K163393 | PREDICATE DEVICE 3 K221274 | | | | | | | | | Regulation | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 890.5850 | Same | | | | | | | | Product codes | QPL, IPF, NGX | QPL | NUH, NGX | IPF, NGX | Same | | | | | | | | Indications for use | | With handheld applicators: PMS mode: Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance. Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation. TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post- surgical pain for patients 18 years or older. | | To stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. | | TENS: To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: It is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance. | | Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. -Relaxation of muscle spasm, -Prevention or retardation of disuse atrophy, -Increasing local blood circulation, -Muscle re-education, -Immediate post- surgical stimulation of calf muscles to prevent venous thrombosis, -Maintaining or increasing range of motion. Fotona StarFormer is indicated for improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen -Strengthening, Toning and Firming of buttocks | and Firming of buttocks and thighs | Same. The TENS (21 CFR 882.5890) and EMS (21 CFR 882.5890) predicate electric stimulation device (K163393) operates on substantially the same principle as the subject magnetic stimulation device i.e. by generating electric impulses to stimulate nerves Depending on the location and intensity of either electrically or magnetically generated electric impulses the outcome can be primarily nerve stimulation for pain reduction, or nerve- activated muscle contraction. | | | | Fotona StarFormer is to | | | | | | | | | | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, lighter gray font. There is a red circle to the right of the word "Fotona". Fotona Fotona Stegne 7, 1000 Ljubljana, Slovenia t. +386 (0)1 500 91 00 f. +386 (0)1 500 92 00 Image /page/7/Picture/3 description: The image shows a gray octagon with a white recycling symbol at the top. Inside the octagon is the text "TUV PRODUCT SERVICE" in a stacked format. The text "ISO 9001" is on the bottom left side of the octagon, and the text "ISO 13485" is on the bottom right side of the octagon. OOFOTONIKA 21 biomedical compete | t. +386 (0)1 500 92 00 www.fotona.com | be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. With Chair Back applicator: TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and post- surgical pain for patients 18 years or older . Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal | household work activities. | | | | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Anatomical Sites | With handheld applicators: For PMS: Legs, hands and arms, shoulder, abdominal muscles (for muscle conditioning only), waist, buttocks, thighs, calf muscles, middle back and lower back For TENS: Legs, hands and arms, shoulder, waist, buttocks, thighs, calf muscles, middle back and lower back With Chair Back applicator: For TENS mode only: Middle back and lower back | Any area, such as hand, arm, waist, buttock, thigh, calf, back and lower back etc. | TENS: Shoulder, waist, back, upper extremities (arm), and lower extremities (leg) EMS: Muscles including abdominal muscles | Arms and legs, abdomen, buttocks, thighs | Same | | Treatment Facilities | Hospitals & clinics (Prescription Use Only) | Hospitals & clinics (Prescription Use Only) | Over-The-Counter Use | Prescription Use Only | Same as predicate devices 1 and 3. Different than predicate device 2. However, professional environment for subject device assures its safe and effective use. | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, light gray sans-serif font. To the right of the word "Fotona" is a red circle. Image /page/8/Picture/1 description: The image shows a gray octagon with a white recycling symbol at the top. Inside the octagon is the "TUV PRODUCT SERVICE" logo. The text "ISO 9001" is on the bottom left of the octagon, and the text "ISO 13485" is on the bottom right. founding member OOOFOTONIKA 21 Fotona Stegne 7, 1000 Ljubljana, Slovenia t. +386 (0)1 500 91 00 f. +386 (0)1 500 92 00 | t. +386 (0)1 500 91 00 f. +386 (0)1 500 92 00 | | | | competency center | biomedical engineering | |--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | www.fotona.com | Handheld applicators: seconds) Up to 30 min Chair Back applicator: Up to 30 min PMS: Handheld applicators: Up to 30 min | | 45 min | Up to 30 min | Since the treatment parameters are set individually and are based on a patient pain threshold this comparison is not relevant for SE evaluation. | | Principle of Action | TENS: Non-invasively stimulate peripheral nerves. PMS: Initiating action potential of nerves that results in muscle contraction. | Non-invasively stimulate peripheral nerves | Not publicly available | Initiating action potential of nerves that results in muscle contraction. | Same | | Type of energy | Magnetic field | Magnetic field | Electrical | Magnetic field | Same as predicate devices 1 and 3. Different than predicate device 2. However, this difference does not affect safety and effectiveness since the principal of action is the same, as explained above. | | Energy source | 100 -240 V AC, 50 ~ 60 Hz | Power supply via Isolation Transformer Power Supply: 120 V~, 50/60Hz | DC 3.7V Lithium Battery | Not publicly available | Similar as predicate devices 1, same as predicate device 3. Different than predicate device 2. Not relevant for SE evaluation since it does not affect safety and effectiveness. | | Type of Applicator | TENS: Magnetic handheld coil applicators including coil applicator in the chair backrest. PMS: Magnetic handheld coil applicators | Magnetic coil applicators | Oval electrode pad(gel), 4.5*3cm, 12cm²; Rectangular electrode pad(gel), 9*4cm, 36cm²; Rectangular electrode pad(gel), 9*6cm, 54cm²; | Magnetic coil in applicators | Same as predicate devices 1 and 3. Different than predicate device 2 due to different type of energy used for generating electric impulses. | | Type of Operation | TENS: Handheld applicators: Continuous Chair Back applicator: Continuous PMS: Handheld applicators: Continuous | Not publicly available | Continuous/complex; 41~181 | Not publicly available | Same | | Number of Output Modes | 2 | Not publicly available | 2 | 1 | Same | | Number of Output Channels | 4…