(86 days)
No
The document describes a standard TENS device with pre-set and editable programs, and the performance studies focus on electrical safety and performance standards, not AI/ML validation. There is no mention of AI, ML, or related concepts.
Yes
The product description explicitly states "The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain." This indicates its intended use for therapy.
No.
The document describes a Transcutaneous Electrical Nerve Stimulator (TENS) which is used for pain relief by applying electrical current, not for diagnosing medical conditions. Its function is therapeutic, not diagnostic.
No
The device description explicitly states it is a "battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and 4x1.5V AAA alkaline batteries," indicating it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for pain relief by applying electrical current to the patient's skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details a Transcutaneous Electrical Nerve Stimulator (TENS) which delivers electrical current to the body. This is consistent with a therapeutic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device directly interacts with the patient's body for therapeutic pain relief.
N/A
Intended Use / Indications for Use
The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and 4x1.5V AAA alkaline batteries. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K213879), Size 50*50mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were conducted on Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) 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:
• ANSI AAMI ES60601-1: 2005/(R) 2012 And A1: 2012, C1: 2009/(R) 2012 And A2: 2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1: 2005, MOD);
· 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;
· IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests;
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
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May 25, 2022
Bozhou Rongjian Medical Appliance Co., Ltd. Wu Zhifang General Manager Jianghuai Supply Base, Zhongkai Group, Mengcheng County Bozhou, Anhui 233500 China
Re: K220578
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: February 18, 2022 Received: February 28, 2022
Dear Wu Zhifang:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
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
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Indications for Use
510(k) Number (if known) K220578
Device Name
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
Indications for Use (Describe)
The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
[As required by 21 CFR 807.92]
| 1. Submission Information | |
|---|---|
| 510(k) Number: | K220578 |
| Date: | April 25, 2022 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Submitter/Manufacturer: | Bozhou Rongjian Medical Appliance Co.,Ltd. |
| Jianghuai Supply Base, Zhongkai Group, Mengcheng County, Bozhou | |
| City, 233500 Anhui, China | |
| Contactor: | Wu Zhifang |
| E-mail: doris.d@ceve.org.cn | |
| Tel: +86-558-7662968 | |
| 2. Device Description | |
| Proprietary Name: | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) |
| Common Name: | TENS (Transcutaneous Electrical Nerve Stimulator) |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | GZJ |
| Device Class: | 2 |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is |
| an electrical nerve stimulator indicated for use for pain relief by | |
| applying an electrical current to electrodes on a patient's skin to treat | |
| pain. In particular, this device is indicated for use for symptomatic relief | |
| of chronic intractable pain and adjunctive treatment in the management of | |
| post surgical and post traumatic pain. | |
| Device Description: | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) sends |
| gentle electrical current to underlying nerves and muscle group via | |
| electrodes applied on the skin to relieve pain. | |
| The device has 16 programs (12 standard programs and 4 editable | |
| programs). It is a battery-powered portable device, comprising electronic | |
| stimulatory module and accessories of lead wires, electrodes and 4×1.5V | |
| AAA alkaline batteries. | |
| Two outlet sockets are used to connect skin electrodes by lead wires. The | |
| accessories of electrodes is 510(k) cleared device (K213879), Size | |
| 50*50mm. |
3. Predicate Device Identification
| Predicate 510(k) Number: | K202893 |
|---|---|
| Marketing clearance date: | June 18, 2021 |
| Product name: | Transcutaneous Electrical Nerve Stimulator |
| Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |
4. Substantially Equivalent Comparison Conclusion
4
| Parameters | New Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(k) Number | K220578 | K202893 | -- |
| Device Name | Transcutaneous Electrical | ||
| Nerve Stimulator (Model | |||
| RJTENS-1) | Transcutaneous Electrical | ||
| Nerve Stimulator | -- | ||
| Manufacturer | Bozhou Rongjian Medical | ||
| Appliance Co.,Ltd. | Wuxi Jiajian Medical | ||
| Instrument Co., Ltd | -- | ||
| Indication for Use | Transcutaneous Electrical Nerve | ||
| Stimulator ((Model RJTENS-1) is | |||
| an electrical nerve stimulator | |||
| indicated for use for pain relief | |||
| by applying an electrical | |||
| current to electrodes on a | |||
| patient's skin to treat pain. In | |||
| particular, this device is indicated | |||
| for use for symptomatic relief of | |||
| chronic intractable pain and | |||
| adjunctive treatment in the | |||
| management of post surgical and | |||
| post traumatic pain. | Transcutaneous Electrical | ||
| Nerve Stimulator is an electrical | |||
| nerve stimulator indicated for | |||
| use for pain relief by applying | |||
| an electrical current to | |||
| electrodes on a patient's skin to | |||
| treat pain. In particular, this | |||
| device is indicated for use for | |||
| symptomatic relief of chronic | |||
| intractable pain and adjunctive | |||
| treatment in the management of | |||
| post surgical and post traumatic | |||
| pain. | Same | ||
| Type of use | Prescription use | Prescription use | Same |
| Power Source(s) | 1.5Vx4 AAA alkaline battery | 1.5Vx4 AAA alkaline battery | Same |
| - Method of Line | |||
| Current Isolation | N/A | N/A | Same |
| - Patient Leakage | |||
| Current | -- | -- | Same |
| - Normal | |||
| Condition (μΑ) | 2μΑ | 2μΑ | Same |
| - Single Fault | |||
| Condition (μΑ) | NA | NA | Same |
| Average DC current | |||
| through electrodes | |||
| when device is on but | |||
| no pulses are being | |||
| applied (μΑ) |