Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 22, 2024 Shenzhen Roundwhale Technology Co., Ltd. Amos Zou RA Manager 202, 2/F, Building 27, Dafa Industrial Park, Longxi Community Longgang Street, Longgang District Shenzhen, Guangdong 518108 China Re: K231423 Trade/Device Name: Combo Electrotherapy Device (Models: R-C101C, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) Regulation Number: 21 CFR 882.5890: 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, GZJ, IPF, NGX Dated: September 5, 2023 Received: September 5, 2023 Dear Amos Zou: 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. 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 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). {2}------------------------------------------------ Sincerely, # Robert Kang -S for Pamela Scott, MS Assistant Director 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) K231423 Device Name Combo Electrotherapy Device Indications for Use (Describe) Over-The-Counter Use: a. Model R-C101C is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. b. Model R-C101D is indicated for OTC TENS. It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. c. Model R-C101F is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. d. Model R-C101G is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. e. Model F100 is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. f. Model MINI-TENS-COMB is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. g. Model R-C101I is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. {4}------------------------------------------------ h. Model TENS3500 is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. Prescription Use: a. Model R-C101D is indicated for Rx TENS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; b. Model R-C101G is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. c. Model R-C101C, is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic rlief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. d. Model F100 is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. e. Model MINI-TENS-COMB is indicated for Rx TENS. {5}------------------------------------------------ | 1)Symptomatic relief of chronic intractable pain; | |---------------------------------------------------| | 2)Post traumatic pain; | | 3)Post surgical pain; | f. Model R-C101F is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : | 1)Symptomatic relief of chronic intractable pain; | |---------------------------------------------------| | 2)Post traumatic pain; | | 3)Post surgical pain; | Rx EMS(IPF): | 1)Relaxation of muscle spasm; | |-------------------------------------------------------------------------------------| | 2)Increase of local blood flow circulation: | | 3)Prevention or retardation of disuse atrophy: | | 4)Muscle re-education: | | 5)Maintaining or increasing range of motion; | | 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. | g. Model R-C101I is indicated for Rx TENS. Rx TENS(GZJ) : | 1)Symptomatic relief of chronic intractable pain; | |---------------------------------------------------| | 2)Post traumatic pain; | | 3)Post surgical pain; | h. Model TENS3500 is indicated for Rx TENS. Rx TENS(GZJ) : | 1)Symptomatic relief of chronic intractable pain; | |---------------------------------------------------| | 2)Post traumatic pain; | | 3)Post surgical pain; | Type of Use (Select one or both, as applicable) | <span style="font-family: DejaVu Sans, sans-serif;">❎</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif;">❎</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. 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." {6}------------------------------------------------ # 510(K) SUMMARY - K231423 This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92. #### Submitter of 510(K): 1. | Sponsor | | |-------------------|-------------------------------------------------------------------------------------------------------------------| | Company Name: | Shenzhen Roundwhale Technology Co., Ltd. | | Address: | 202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang street, Longgang district, Shenzhen, China. | | Contact person: | Zeng Chunming | | TEL: | +86-755-23212776 | | FAX: | +86-755- 23212776 | | E-mail: | zcm@roovjoy.com | | Date of Prepared: | December 11,2023 | #### Application Correspondent: | Company Name: | Shenzhen Roundwhale Technology Co., Ltd. | |-------------------|----------------------------------------------------------------------------------------------------------------------| | Address: | 202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang<br>street, Longgang district, Shenzhen, China. | | Contact person: | Amos Zou | | TEL: | +86-15015249549 | | E-mail: | amos.zou@139.copm | | Date of Prepared: | December 11,2023 | #### 2. Proposed Device and code: | Device | Combo Electrotherapy Device | | | | | | | | |-------------------------------|-----------------------------|------------|------------|------------|------------|------------------------|------------|------------| | name: | | | | | | | | | | Model: | R-C101C | R-C101D | R-C101F | R-C101G | F100 | MINI-<br>TENS-<br>COMB | R-C101I, | TENS3500 | | associa | OTC | OTC | OTC | OTC | OTC | OTC | OTC | OTC | | ted | TENS, | TENS, | TENS, | TENS, | TENS, | TENS, | TENS, | TENS, | | claims | OTC<br>EMS | OTC<br>EMS | OTC<br>EMS | OTC<br>EMS | OTC<br>EMS | OTC<br>EMS | OTC<br>EMS | OTC<br>EMS | | Classifi<br>cation<br>product | NUH | NUH | NUH | NUH | NUH | NUH | NUH | NUH | {7}------------------------------------------------ | code: | | | | | | | | | |------------------------------------|----------------------------|---|-----|-----|-----|---|---|---| | Subsequ<br>ent<br>product<br>code: | NGX | / | NGX | NGX | NGX | / | / | / | | Regulati<br>on<br>number: | 1) 882.5890<br>2) 890.5850 | | | | | | | | | Device<br>name: | Combo Electrotherapy Device | | | | | | | | |------------------------------------|-----------------------------|----------|--------------------|--------------------|--------------------|----------------|----------|----------| | Model: | R-C101C | R-C101D | R-C101F | R-C101G | F100 | MINI-TENS-COMB | R-C101I, | TENS3500 | | associated<br>claims | Rx TENS,<br>Rx EMS | Rx TENS, | Rx TENS,<br>Rx EMS | Rx TENS,<br>Rx EMS | Rx TENS,<br>Rx EMS | Rx TENS, | Rx TENS, | Rx TENS | | Classification<br>product<br>code: | GZJ | GZJ | GZJ | GZJ | GZJ | GZJ | GZJ | GZJ | | Subsequent<br>product<br>code: | IPF | / | IPF | IPF | IPF | / | / | / | | Regulation<br>number: | 1)882.5890<br>2)890.5850 | | | | | | | | #### 3. Predicate Device: Primary predicate device | 510(K) | Trade or Proprietary or Model Name | Manufacturer | Product Code | |---------|------------------------------------|------------------------------------------|-----------------| | K192087 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co., Ltd. | NUH,GZJ,IPF,NGX | # Reference Predicate device | 510(K) | Trade or Proprietary or Model Name | Manufacturer | Product Code | |--------------------|------------------------------------|------------------------------------------|--------------------| | K181688&1<br>80956 | TENS and EMS Stimulator R-C1 | Shenzhen Roundwhale Technology Co., Ltd. | IPF, GZJ; NUH, NGX | {8}------------------------------------------------ #### 4. Description of Proposed Device: Combo Electrotherapy Device (Model:R-C101C,R-C101F,R-C101G,F100,MINI-TENS-COMB,R-C1011, TENS3500) are Transcutaneous Electrical Nerve Stimulator and muscle stimulator The Device feature two independent output channels and four self-adhesive electrode gel pads. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrode applied on the skin. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation.For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs. Software controls all controls and indicators. Software controls waveform characteristics. The 8 models have Similar housing with a viewable LCD display,an accessible keypad.The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user. The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is 3.7V D.C.,Li-ion batteries and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device. The Battery Charger is not provided in the package, but users will choose adapters that meet the IEC 60601-1 medical standard. All of the accessories for use with this device are already marketed in the U.S. and are either Class II 510(k) exempt or Class II previously cleared devices. The accessories Include the following: - self-adhesive electrode (50mm x 50mm) with conductive media (gel) and Electrode Lead Wires that is a Class II previously approved device. (K222252,manufacturer:Shenzhen Roundwhale Technology Co., Ltd.), and can be packaged with 510(k) cleared devices or packaged separately as a replacement electrode for 510(k) cleared devices.The exact proportions of the ingredients used in the electrode patch/pad may be withheld as a trade secret. - An electrode cable is a device composed of strands of insulated electrical conductors laid together around a ● central core and intended for medical purposes to connect an electrode from a patient to a diagnostic,submission type:510(k) Exempt,device class:2, Regulation Number:890.1175 - USB Cable Is not a medical device, used to connect the external power supply to charge the lithium battery, The Battery Charger is not provided in the package, but users will choose adapters that meet the IEC 60601-1 medical standard。 The accessories can be packaged with 510(k) cleared devices or packaged separately as a replacement electrode for 510(k) cleared devices. #### న్. Indications for Use #### Over-The-Counter Use: a. Model R-C101C is indicated for OTC TENS and OTC EMS. ### OTC TENS (NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. #### OTC EMS (NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. b. Model R-C101D is indicated for OTC TENS. #### OTC TENS(NUH) {9}------------------------------------------------ It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. c. Model R-C101F is indicated for OTC TENS and OTC EMS. #### OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. #### OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. #### d. Model R-C101G is indicated for OTC TENS and OTC EMS. #### OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. #### OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. #### e. Model F100 is indicated for OTC TENS and OTC EMS. #### OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. #### OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. #### f. Model MINI-TENS-COMB is indicated for OTC TENS. ### OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. g. Model R-C101I is indicated for OTC TENS. ### OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. {10}------------------------------------------------ h. Model TENS3500 is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. #### Prescription Use: a. Model R-C101D is indicated for Rx TENS. Rx TENS(GZJ). 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; b. Model R-C101G is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ): 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. c. Model R-C101C, is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ): 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): {11}------------------------------------------------ 1)Relaxation of muscle spasm; - 2)Increase of local blood flow circulation: - 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: - 5)Maintaining or increasing range of motion; - 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. d. Model F100 is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ): 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. e. Model MINI-TENS-COMB is indicated for Rx TENS. Rx TENS(GZJ): 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; f. Model R-C101F is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ): 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): {12}------------------------------------------------ 1)Relaxation of muscle spasm; - 2)Increase of local blood flow circulation: - 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: - 5)Maintaining or increasing range of motion; - 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. g. Model R-C101I is indicated for Rx TENS. - Rx TENS(GZJ): 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; ### h. Model TENS3500 is indicated for Rx TENS. Rx TENS(GZJ): 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; #### Technical and Performance 6. The following table compares the device to the predicate device with basic technological characteristics. {13}------------------------------------------------ | Item | Primary predicate device<br>(K192087) | Reference Predicate device<br>(K181688&180956) | Subject Device<br>(K231423) | Discussion | | |-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | 510(K) | K192087 | K181688&180956 | K231423 | / | | | Device Name | Combo Electrotherapy Device, model R-<br>C3,R-C4A, R-C4B, R-C4C and R-C4D | TENS and EMS Stimulator R-C1 | Combo Electrotherapy Device,<br>Model:R-C101C,R-C101D,R-C101F,R-<br>C101G, F100,MINI-TENS-COMB,R-<br>C101I, TENS3500) | / | | | Manufacturer | Shenzhen Roundwhale Technology Co.,<br>Ltd. | Shenzhen Roundwhale Technology Co.,<br>Ltd. | Shenzhen Roundwhale Technology Co.,<br>Ltd. | / | | | Prescription or OTC | OTC & Prescription | Prescription & OTC | OTC & Prescription | Same | | | FDA product code | NUH, NGX, IPF, GZJ | IPF, GZJ; NUH, NGX | NUH, NGX, IPF, GZJ | Same | | | Intended Use | Over-The-Counter Use: | Over-the-Counter Use: | Over-The-Counter Use: | Same | | | | TENS mode: | For TENS: | a. Model R-C101C is indicated for OTC<br>TENS and OTC EMS. | | | | | It is used for temporary relief of pain<br>associated with sore and aching muscles<br>in the neck, shoulder, back, upper<br>extremities (arm) and lower extremities<br>(leg) due to strain from exercise or<br>normal household work activities.<br>EMS mode:<br>This mode is designed to be used for<br>stimulate healthy muscles in order to<br>improve and facilitate muscle<br>performance<br>Prescription Use:<br>For TENS mode:<br>1)Symptomatic relief of chronic | This mode is designed to be used for<br>temporary relief of pain associated with<br>sore and aching muscles in the shoulder,<br>waist, back, neck, upper extremities (arm),<br>and lower extremities (leg) due to strain<br>from exercise or normal household work<br>activities.<br>For EMS:<br>This mode is designed to be used for<br>stimulate healthy muscles in order to<br>improve and facilitate muscle performance.<br>Prescription Use:<br>For TENS mode:<br>1)Symptomatic relief of chronic intractable | OTC TENS(NUH)<br>It is used for temporary relief of pain<br>associated with sore and aching muscles<br>in the neck, shoulder, back, upper<br>extremities (arm) and lower extremities<br>(leg) due to strain from exercise or<br>normal household work activities.<br>OTC EMS(NGX)<br>This mode is designed to be used for<br>stimulate healthy muscles in order to<br>improve and facilitate muscle<br>performance. | | | | | intractable pain;<br>2)Post traumatic pain; | pain;<br>2)Post traumatic pain; | b. Model R-C101D is indicated for OTC<br>TENS. | | | | Item | Primary predicate device<br>(K192087) | Reference Predicate device<br>(K181688&180956) | Subject Device<br>(K231423) | Discussion | | | | 3)Post surgical pain; | 3)Post surgical pain; | OTC TENS(NUH) | | | | | For EMS mode: | For EMS mode: | It is used for temporary relief of pain<br>associated with sore and aching muscles<br>in the neck, shoulder, back, upper<br>extremities (arm) and lower extremities<br>(leg) due to strain from exercise or<br>normal household work activities. | | | | | 1)Relaxation of muscle spasm; | 1)Relaxation of muscle spasm; | | | | | | 2)Increase of local blood flow<br>circulation: | 2)Increase of local blood flow circulation; | | | | | | 3)Prevention or retardation of disuse<br>atrophy: | 3)Prevention or retardation of disuse<br>atrophy; | | | | | | 4)Muscle re-education: | 4)Muscle re-education; | c. Model R-C101F is indicated for OTC<br>TENS and OTC EMS. | | | | | 5)Maintaining or increasing range of<br>motion; | 5)Maintaining or increasing range of<br>motion; | OTC TENS(NUH) | | | | | 6) Immediate post-surgical stimulation of<br>calf muscles to prevent venous<br>thrombosis. | 6)Immediate post-surgical stimulation of<br>calf muscles to prevent venous thrombosis. | It is used for temporary relief of pain<br>associated with sore and aching muscles<br>in the neck, shoulder, back, upper<br>extremities (arm) and lower extremities<br>(leg) due to strain from exercise or<br>normal household work activities. | | | | | | | OTC EMS(NGX) | | | | | | | This mode is designed to be used for<br>stimulate healthy muscles in order to<br>improve and facilitate muscle<br>performance. | | | | | | | d. Model R-C101G is indicated for OTC<br>TENS and OTC EMS. | | | | | | | OTC TENS(NUH) | | | | | | | It is used for temporary relief of pain<br>associated with sore and aching muscles<br>in the neck, shoulder, back, upper<br>extremities (arm) and lower extremities<br>(leg) due to strain from exercise or<br>normal household work activities. | | | | Item | Primary predicate device<br>(K192087) | Reference Predicate device<br>(K181688&180956) | Subject Device<br>(K231423) | Discussion | | | | | | OTC EMS(NGX) | | | | |…