Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION November 24, 2025 Bozhou Rongjian Medical Appliance Co., Ltd. % Doris Dong Shanghai CV Technology Co., Ltd. Room 805, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China Re: K252688 Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (RJTENS-2) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: August 25, 2025 Received: August 26, 2025 Dear Doris Dong: 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. 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" U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252688 - Doris Dong Page 2 (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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-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). {2} K252688 - Doris Dong Page 3 Sincerely, Heather L. Dean -S for Pamela Scott 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} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K252688 | | | Device Name Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | | | Indications for Use (Describe) Transcutaneous Electrical Nerve Stimulator (Model: RJTENS-2) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment. | | | Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} 510(k) Summary [As required by 21 CFR 807.92] 1. Submission Information 510(k) Number: K______ Date: August 25, 2025 Type of 510(k) Submission: Traditional 510(k) Applicant /Manufacturer: Bozhou Rongjian Medical Appliance Co., Ltd. Jianghuai Supply Base, Zhongkai Group, Mengcheng County, Bozhou, Anhui, 233500, China E-mail: doris.d@ceve.org.cn Tel: +86-558-7963368 Submitter &amp; Contact: Doris Dong E-mail: doris.d@ceve.org.cn Tel: 86 21-31261348 2. Device Description Proprietary Name: Transcutaneous Electrical Nerve Stimulator Model: RJTENS-2 Common Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Product Code: NUH Regulation Number: 882.5890 Device Class: 2 Review Panel: Neurology Indications for use: Transcutaneous Electrical Nerve Stimulator (Model: RJTENS-2) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment. Device Description: Transcutaneous Electrical Nerve Stimulator (Model: RJTENS-2) sends gentle electrical current to underlying nerves and muscle groups via electrodes applied onto the skin to relieve pain. The device has 14 programs (11 standard programs and 3 editable programs). It is a lithium battery-powered device comprising the electronic stimulatory module, the accessories of lead wires, the electrodes and the adapter. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes are 510(k) cleared devices (K213879). Size: 50*50mm. 3. Predicate Device Identification Predicate 510(k) Number: K231425 Marketing clearance date: 03/27/2024 Product name: Transcutaneous Electrical Nerve Stimulator (Model: TENS WMPS2-1) Manufacturer: Wuxi Jiajian Medical Instrument Co., Ltd {5} 4. Substantially Equivalent Comparison Conclusion | Parameters | New Device | Predicate Device | Compa rison | | --- | --- | --- | --- | | 510(k) Number | To be assigned | K231425 | -- | | Device Name | Transcutaneous Electrical Nerve Stimulator | Transcutaneous Electrical Nerve Stimulator | -- | | Model | RJTENS-2 | TENS WMPS2-1 | -- | | Manufacturer | Bozhou Rongjian Medical Appliance Co., Ltd. | Wuxi Jiajian Medical Instrument Co., Ltd | -- | | Intended use | Transcutaneous Electrical Nerve Stimulator (Model: RJTENS-2) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment. | Transcutaneous Electrical Nerve Stimulator (Model: TENS WMPS2-1) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment. | Same | | Type of use | OTC | OTC | Same | | Power Source(s) | DC3.7 V Li-battery powered | DC3.7 V Li-battery powered | Same | | - Method of Line Current Isolation | N/A | N/A | Same | | - Patient Leakage Current - Normal Condition (μA) | -- | -- | Same | | - Single Fault Condition (μA) | 2μA | 2μA | | | | NA | NA | | | Average DC current through electrodes when device is on but no pulses are being applied (μA) | <0.01μA | <0.01μA | Same | | Number of program | 16 | 14 | Similar Note 1 | | Number of Output channels: | 2 | 2 | Same | | - Synchronous or Alternating? | Alternating | Alternating | Same | | - Method of Channel Isolation | By Transformer | By Transformer | Same | | Regulated Current or Regulated Voltage? | Current control | Current control | Same | | Software/Firmware/Micro processor Control? | Yes | Yes | Same | | Automatic Overload Trip? | No | No | Same | | Automatic No-Load Trip? | No | No | Same | | Automatic Shut Off? | Yes | Yes | Same | {6} | User Override Control? | | Yes | Yes | Same | | --- | --- | --- | --- | --- | | Indicat or Display | On/Off Status? | Yes | Yes | Same | | | Low Battery? | Yes | Yes | Same | | | Voltage/Current Level? | Yes | Yes | Same | | Timer Range (minutes) | | 10~90 min | 10~99 min | Similar Note 1 | | Compliance with Voluntary Standards? | | AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 | AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 | Same | | Compliance with 21 CFR 898? | | Yes | Yes | Same | | Weight (grams) | | Approx. 106g | Approx.106g | Same | | Dimensions (mm) [W x H x D] | | 140*60*20 mm | 140*60*20 mm | Same | | Housing Materials & Construction | | ABS | ABS | Same | | Waveform | | Biphasic | Biphasic | Same | | Shape | | Square | Square | Same | | Maximum Output Voltage (volts) | | 15V±20% @500Ω | 15V±20% @500Ω | Same | | Maximum Output Current (specify units) | | 30mA±20% @500Ω | 30mA±20% @500Ω | Same | | Pulse width (μsec) | | 75-300μs±20% | 75-300μs±20% | Same | | Pulse Period (msec) | | 8.33-1000ms | 8.33-1000ms | Same | | Max. pulse frequency (Hz) [or Rate (pps)] | | 1-120Hz±20% | 1-120Hz±20% | Same | | Net Charge (μC per pulse) | | 0μC @500Ω(Method: Balanced waveform) | 0μC @500Ω(Method: Balanced waveform) | Same | | Maximum Phase Charge, (μC) | | 9μC @500Ω | 9μC @500Ω | Same | | Maximum Average Current, (mA) | | 2.16mA @500Ω | 2.16mA @500Ω | Same | | Maximum Current Density, (mA/cm2, r.m.s.) | | 0.043mA/cm2 @500Ω | 0.043mA/cm2 @500Ω | Same | | Maximum Average Power Density, (mW/cm2) | | 1.30mW/cm2 @500Ω | 1.30mW/cm2 @500Ω | Same | | Accessories | | Electrodes, cables, adapter | Electrodes, cables, adapter | Same | | Comparison in details: Note 1: The timer range and number of program of the proposed device are a little different from those of the predicate device, depending on the design and sales requirements of the product. But these differences are insignificant in terms of safety or effectiveness. | | | | | # 5. Non-Clinical Test Conclusion {7} Bench tests were conducted on Transcutaneous Electrical Nerve Stimulator to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The following tests were performed on the proposed device: 1) ANSI AAMI ES60601-1:2005/(R)2012 &amp; A1:2012, C1:2009/(R)2012 &amp; A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] 2) ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)] 3) IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment -- Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators. 4) IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 5) IEC 62133 Edition 2.0 2012-12, IEC 62133 Edition 2.0 2012-12 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications [Including: Corrigendum 1 (2013)] ## 6. Clinical Test Clinical data was not including in this submission. ## 7. Conclusions The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate device. 4