(263 days)
No
The summary describes a standard TENS device with pre-set and editable programs, focusing on electrical stimulation and safety standards. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is a Transcutaneous Electrical Nerve Stimulator explicitly indicated for pain relief, which is a therapeutic purpose.
No
The device is a Transcutaneous Electrical Nerve Stimulator (TENS), indicated for pain relief by applying electrical current, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and battery," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a Transcutaneous Electrical Nerve Stimulator (TENS). It works by applying electrical current to electrodes on the patient's skin to treat pain. This is a form of therapy applied to the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for pain relief, specifically symptomatic relief of chronic intractable pain and adjunctive treatment of post-surgical and post-traumatic pain. This is a therapeutic indication, not a diagnostic one.
The information provided aligns with a medical device used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The 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 of post surgical and post traumatic pain.
Product codes
GZJ
Device Description
Transcutaneous Electrical Nerve Stimulator is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The device has standard programs and edit programs. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and battery. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), 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 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
June 18, 2021
Wuxi Jiajian Medical Instrument Co., Ltd Caihong Sun Regulatory Assurance No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu 214116 China
Re: K202893
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: April 25, 2021 Received: May 17, 2021
Dear Caihong Sun:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
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
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Indications for Use
510(k) Number (if known) K202893
Device Name
Transcutaneous Electrical Nerve Stimulator
Indications for Use (Describe)
The 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 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Jiajian. The logo is in a teal color and features the text "JIA JIAN" in a sans-serif font. A check mark is used in place of the space between the two words. Below the text is the company name in Chinese characters.
510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K202893 |
|---|---|
| Date: | April 15, 2021 |
| Type of 510(k) Submission: | Special |
| Submitter/Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |
| No.35 Baiqiao Rd., Ehu Town, Xishan District, | |
| Wuxi, Jiangsu, China 214116 | |
| E-mail: sch@jjmed.com.cn | |
| Tel: 86 510-88745788 | |
| Contactor: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description:
| Proprietary Name: | Transcutaneous Electrical Nerve Stimulator |
|---|---|
| Common Name: | TENS (Transcutaneous Electrical Nerve Stimulator) |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | GZJ |
| Device Class: | II |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | 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. | |
| Device Description: | Transcutaneous Electrical Nerve Stimulator is Transcutaneous Electrical |
| Nerve Stimulator for pain relief. The stimulator sends gentle electrical | |
| current to underlying nerves and muscle group via electrodes applied on | |
| the skin. | |
| The device has standard programs and edit programs. It is a | |
| battery-powered portable device, comprising electronic stimulatory | |
| module and accessories of lead wires, electrodes and battery. | |
| Two outlet sockets are used to connect skin electrodes by lead wires. The | |
| accessories of electrodes is 510(k) cleared device (K192568), Size: | |
| 50*50mm. |
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Image /page/4/Picture/0 description: The image shows a logo for a company called JIA JIAN. The logo is in blue and features the company name in a stylized font. There is a check mark above the letters IA. Below the company name are Chinese characters.
3. Substantially Equivalent Comparison Conclusion
| Parameters | Modified Device | Predicate Device | Remark | |
|---|---|---|---|---|
| 510(k) Number | K202893 | K112288 | -- | |
| Device Name | Transcutaneous Electrical Nerve | |||
| Stimulator | Jiajian® TENS | -- | ||
| Model | TENStem eco basic | / | -- | |
| Manufacturer | Wuxi Jiajian Medical Instrument | |||
| Co., Ltd | Wuxi Jiajian Medical | |||
| Instrument Co., Ltd | Same | |||
| Intended use | 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. | Jiajian® TENS 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 | 9V Battery type 6F22 | Similar | |
| Note 1 | ||||
| - Method of Line | ||||
| Current Isolation | N/A | NA | Same | |
| - Patient Leakage | ||||
| Current | -- | -- | ||
| - Normal | ||||
| Condition (μΑ) | 2μΑ | 2μΑ | Same | |
| - Single Fault | ||||
| Condition (μΑ) | NA | NA | ||
| Average DC current | ||||
| through electrodes | ||||
| when device is on but | ||||
| no pulses are being | ||||
| applied (μΑ) |