(99 days)
No
The summary describes a standard TENS/EMS device with pre-programmed modes and does not mention any AI or ML capabilities.
Yes
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) intended for temporary relief of pain and to improve or facilitate muscle performance, which are therapeutic applications.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "designed to be used for temporary relief of pain" and "to stimulate healthy muscles in order to improve or facilitate muscle performance." These are therapeutic or performance enhancement uses, not diagnostic.
No
The device description explicitly states it is a "portable, battery powered (lithium battery 3.7V DC) multifunction device" and mentions "4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads". This indicates a physical hardware component that delivers electrical stimulation, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for temporary relief of pain and muscle stimulation. These are therapeutic applications, not diagnostic ones.
- Device Description: The description details a device that delivers electrical pulses to the body via electrodes. This is consistent with TENS and EMS devices, which are used for physical therapy and pain management.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
The device of the model FM-B2403A is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg.
4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations.
The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age >= 18) multiple application use.
Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom
Indicated Patient Age Range
age >= 18
Intended User / Care Setting
Over-The-Counter Use
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)
Non-clinical tests have been conducted to verify that the transcutaneous electrical nerve stimulator and/or powered muscle stimulator meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:
ANSI/AAMI/ES 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
IEC60601-1-11, 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
IEC60601-2-10, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
The body-contacting components of this device are electrode patches. We have directly purchased the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K092546, so we have reason to believe that the electrode patches are safe for the users. The electrode patches comply to the following standards:
- ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests for In Vitro Cytotoxicity;
- ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
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).
0
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March 8, 2022
Shenzhen Jianfeng Electronic Technology Co. Ltd. Feng Wen General Manager 902, 903 Jialingyu Industrial Building, Da Pu Road Houting Village, Shajing Town, Baoan District Shenzhen, Guangdong 518104 China
Re: K213741
Trade/Device Name: TENS & EMS Device (Model: FM-B2403A) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH. NGX Dated: December 17, 2021 Received: December 17, 2021
Dear Feng Wen:
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
1
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 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-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,
Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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
2
Indications for Use
510(k) Number (if known) K213741
Device Name TENS & EMS Device (Model: FM-B2403A)
Indications for Use (Describe) TENS:
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS:
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K213741
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
-
- Type of 510(k) submission: Traditional Date of the summary prepared: Feb-17-2022
-
- Submitter's Information Submitter: SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. Address: 902, 903 Jialingyu Industrial Building, Da Pu Road, Houting Village, Shajing Town, Baoan District, Shenzhen City, Guangdong Province, 518104, China. Contact Person: Feng Wen Email: wenfeng@fzjhealth.com Tel: +86-755-33858361 Fax: +86-755-33858360
Application Correspondent Company: SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. Address: 902, 903 Jialingyu Industrial Building, Da Pu Road, Houting Village, Shajing Town, Baoan District, Shenzhen City, Guangdong Province, 518104, China. Contact Person: Feng Wen Title: General Manager Email: wenfeng@fzjhealth.com Tel: +86-755-33858361 Fax: +86-755-33858360
-
- Subject Device Information
Trade Name: TENS & EMS Device (Model: FM-B2403A) Common Name: TENS, EMS, Stimulator for pain relief; Classification Name: Powered muscle stimulator; Transcutaneous electrical nerve stimulator for pain relief; Nerve muscle stimulator Review Panel: Physical Medicine; Neurology Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890, 21 CFR 890.5850 Device Classification: Class II
- Subject Device Information
-
Use: Over-the-Counter Use (OTC)
-
- The Predicate Device Information
| Basic Information | Predicate Device |
|---|---|
| Manufacturer | Shenzhen Jian Feng Electronic Technology Co., Ltd. |
4
| Device Name | TENS & EMS Device |
|---|---|
| Model | FM-B2403 |
| 510(K) Number | K202866 |
| Product Code | NUH, NGX |
| Panel Code | Physical Medicine, Neurology |
| Regulation Number | 21 CFR 882.5890 |
| 21 CFR 890.5850 | |
| Regulation Class | Class II |
5. Device Description / Design of Device
The device of the model FM-B2403A is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg.
4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations.
The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age ≥ 18) multiple application use.
Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.
6. Indication for Use
TENS:
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS:
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
- Technological characteristics and substantial equivalence
- 7.1 The following table is the basic characteristic:
5
| Contents | New device | Predicate Device | SE | |
|---|---|---|---|---|
| Trade Name | TENS & EMS Device | TENS & EMS Device | SE | |
| Device Model | FM-B2403A | FM-B2403 | / | |
| 510(k) Number | To Be Assigned | K202866 | / | |
| Manufacturer | Shenzhen Jian Feng Electronic | |||
| Technology Co., Ltd. | Shenzhen Jian Feng Electronic | |||
| Technology Co., Ltd. | SE | |||
| Regulatory Information | 882.5890, 890.5850 | 882.5890, 890.5850 | SE | |
| Classification | Class II | Class II | SE | |
| Product code | NUH, NGX | NUH, NGX | SE | |
| Panel | Physical Medicine; Neurology | Physical Medicine; Neurology | SE | |
| OTC/RX | OTC | OTC | SE | |
| Intended Use | TENS: The device is designed | |||
| to be used for temporary relief | ||||
| of pain associated with sore | ||||
| and aching muscles in the | ||||
| shoulder, waist, back, neck, | ||||
| upper extremities (arm), lower | ||||
| extremities (leg), abdomen and | ||||
| bottom due to strain from | ||||
| exercise or normal household | ||||
| work activities. | ||||
| EMS: The device is designed | ||||
| to be used to stimulate healthy | ||||
| muscles in order to improve or | ||||
| facilitate muscle performance. | TENS: The device is designed | |||
| to be used for temporary relief | ||||
| of pain associated with sore | ||||
| and aching muscles in the | ||||
| shoulder, waist, back, neck, | ||||
| upper extremities (arm), lower | ||||
| extremities (leg), abdomen and | ||||
| bottom due to strain from | ||||
| exercise or normal household | ||||
| work activities. | ||||
| EMS: The device is designed | ||||
| to be used to stimulate healthy | ||||
| muscles in order to improve or | ||||
| facilitate muscle performance. | SE | |||
| Apply parts of the body | Shoulder, waist, back, neck, | |||
| upper extremities (arm), lower | ||||
| extremities (leg), abdomen and | ||||
| bottom | Shoulder, waist, back, neck, | |||
| upper extremities (arm), lower | ||||
| extremities (leg), abdomen and | ||||
| bottom | SE | |||
| Power Source | Built-in 3.7V lithium battery | Built-in 3.7V lithium battery | SE | |
| - Method of Line Current | ||||
| Isolation | BF | BF | SE | |
| - Patient Leakage Current | / | / | SE | |
| - Normal condition |