(270 days)
No
The device description focuses on basic electrical stimulation technology and user controls. There is no mention of AI, ML, data processing, or complex algorithms that would indicate the use of such technologies.
Yes
This device is intended for the temporary relief of pain associated with sore and aching muscles and to stimulate healthy muscles to improve performance, aligning with the definition of a therapeutic device designed to treat or alleviate symptoms or conditions.
No
Explanation: The device is described as a muscle stimulator for pain relief and muscle performance improvement, emitting electrical pulses. Its intended use and description do not mention any diagnostic capabilities or functions to identify or analyze medical conditions.
No
The device description explicitly states it is a "portable and DC 3.7V battery powered multifunction device" with physical components like an On/Off Switch, Intensity buttons, Output ports, LCD display, and accessories like electrode pads and cables. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a TENS and PMS device for pain relief 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 a therapeutic stimulator, not a device that analyzes samples from the body (which is the core function of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any of those functions.
N/A
Intended Use / Indications for Use
TENS(Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device.
Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electrodes to be used with the device have already been cleared under K182111.
The electronic stimulatory module has the operating elements of an On/Off Switch, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging.
The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity, etc.
The device is equipped with accessories of electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, upper extremities (arm), and lower extremities (leg)
Indicated Patient Age Range
Not Found
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 Testing:
-
- 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
-
- ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests;
-
- IEC 62133-2 Edition1.0 2017-02 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 - Part 2: Lithium Systems
-
- IEC 60601-1-11 Edition 2.0 2015-01, 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 . (General II (ES/EMC))
The conclusion drawn from the safety testing is that the new devices are substantially equivalent to the predicate devices. Furthermore, the new devices comply with the recognized standards and perform its intended tasks as well as the legally marketed predicate devices.
Clinical Testing: No clinical testing was performed on the device.
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
Image /page/0/Picture/0 description: The image contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 1, 2024
Shenzhen Yiran Intelligent Co., Ltd % Tulin Li Regulatory Manager Huide Medical Technology Service (Shenzhen) Group Co., Ltd. Room 703, Building 16, South Bank Plaza, Exhibition Bay, Zhancheng Community, Fuhai Street, Shenzhen, Guangdong 518053 China
Re: K231648
Trade/Device Name: Muscle Stimulator 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, NGX Dated: February 26, 2024 Received: February 27, 2024
Dear Tulin Li:
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.
Robert Kang -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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231648
Device Name Muscle Stimulator
Indications for Use (Describe)
TENS(Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and 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
510(k) number: K231648
Date of Summary Preparation: Feb 29, 2024
Applicant
Name: Shenzhen Yiran Intelligent Co., Ltd Address: Floor 6, No. 531 Nanpu Road, Huangpu Community, Xinqiao Street, Bao'an District, Shenzhen, Guangdong, China
Official Correspondent: Huide Medical Technology Service (Shenzhen) Group Co., Ltd. Name: Tulin Li Tel: 0086-186067546446 Mail: yiranintelligent@gmail.com
Device
| Trade Name: | Muscle Stimulator |
|---|---|
| Common Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter; |
| Power Muscle Stimulator | |
| Model Name: | YR-U80-PRO-MAX,YR-U80-PRO, YR-U8-PRO, YR-U8 |
| Regulation Classification | 21 CFR 882.5890, 21 CFR 890.5850 |
| Product Code: | NUH, NGX |
| Classification Panel: | Physical Medicine |
| Device Class: | II |
Predicate Device
510(k) number: K143268
| Trade Name: | TENS AND POWERED MUSCLE STIMULATOR |
|---|---|
| Common Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Power Muscle Stimulator | |
| Model Name: | AS-TEC |
| Regulation Classification | 21 CFR 882.5890, 21 CFR 890.5850 |
| Product Code: | NUH, NGX |
| Classification Panel: | Physical Medicine |
| Device Class: | II |
Reference Device
510(k) number: K121719
| Trade Name: | SM TENS&PMS |
|---|---|
| Common Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter; Power Muscle Stimulator |
| Model Name: | NA |
4
| Regulation Classification | 21 CFR 882.5890, 21 CFR 890.5850 |
|---|---|
| Product Code: | NUH, NGX |
| Classification Panel: | Physical Medicine |
| Device Class: | II |
Device Description:
Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device.
Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electrodes to be used with the device have already been cleared under K182111.
The electronic stimulatory module has the operating elements of an On/Off Switch, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging.
The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity, etc.
The device is equipped with accessories of electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the device; the USB cable is
used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.
Indications for use:
TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Comparison table
| | | New Device | Predicate
Device | Reference
device | Same/Di
fferent |
|-----|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| 1. | 510(k) Number | K231648 | K143268 | K121719 | |
| 2. | Marketing
clearance
date | / | 07/21/2015 | 10/23/2012 | |
| 3. | Device Name | Muscle
Stimulator | TENS AND
POWER
ED
MUSCLE
STIMULATOR | SM TENS & PMS | |
| 4. | Model | YR-U80-PRO-
MAX,YR-U80-PRO,
YR-U8-PRO,YR-U8 | AS-TEC | NA | |
| 5. | Manufacturer | Shenzhen Yiran
Intelligent Co., Ltd | Shenzhen
Technology Co., | Hong Qiangxing
(Shen Zhen)
Electronics | |
| | | | Ltd. | Limited | |
| 6. | Intended use | TENS (Program 3, 4):
To be used for
temporary
sore and aching
muscles in relief of
pain associated with
the shoulder, waist,
back, upper
extremities (arm),and
lower extremities
(leg) due to strain
from exercise or
normal household
work activities.
PMS (Program 1, 2,
5,6):
It is intended to be
used to stimulate
healthy muscles in
Order to improve
and Facilitate
muscle
performance. | TENS (Mode 1,
3, 4, 5,
6):
To be used for
temporary
relief of pain
associated with
sore and aching
muscles in
the shoulder,
waist, back,
upper
extremities
(arm), and
lower
extremities
(leg) due
to strain from
exercise or
normal
household work
activities.
PMS (Mode 1, 2,
3, 5):
It is intended to
be used to
stimulate
healthy muscles
in order to
improve and
facilitate muscle
performance | TENS:
To be used for
temporary relief
of pain
associated with
sore and aching
muscles in the
shoulder, waist,
back, neck,
upper extremities
(arm), and lower
extremities (leg)
due to strain from
exercise or
normal
household work
activities.
PMS: It is
intended to be
used to stimulate
healthy muscles
in order to
improve and
facilitate muscle
performance. | Same Note 1 |
| 7. | Type of use | OTC | OTC | OTC | Same |
| 7.8 | Power Source(s) | DC 3.7V lithium
battery | DC 3.7V lithium
battery | DC 3.7V lithium
battery | Same |
| | - Method of Line
Current Isolation | Type BF | Type BF | Type BF | Same |
| | - Patient
Leakage
Current | -- | -- | -- | Same |
| | - Normal
Condition (μΑ) | 0.1μA | 0.1μA | 2 μA | |
| | - Single Fault
Condition (μΑ) | 0.1μA | 0.1μA | Note 1: |
| The proposed device has more treatment programs than the predicate device
K143268, but allof the treatment programs have passed the IEC 60601-2-10 test
codes. So this difference doesn't raise any safety issues. And the weight,
dimensions, housing material, appearance of proposed device are a little
different from predicate device K143268. Consider the same intended use,
components, working principle, test standards, these differences are
insignificant in the terms of safety or effectiveness. |
| Note 2: |
| The maximum phase charge of the proposed device (15.87µC@500Ω) is less
than the predicate device (48µC @500Ω), but the cleared device K121719, which
is the predicate device of K143268, has the maximum phase charge of
16.8µC@500Ω. The value of the proposed device is similar to that of the 510K
clearance device K121719, therefore this difference doesn't raise any new safety
and effectiveness issues. |
| The maximum average current, maximum current density, maximum average
power density have some differences between proposed device and predicate
device due to they are calculated by different electrode area. Both of them meet
maximum current density Note 3
The reference device is being included to demonstrate that the different technological
parameters do not have an effect on the safety and effectiveness of the subject
device |
Muscle Stimulator is safe and effective as the predicate devices cited above. The new devices have passed testing according to the safety standards:
Non-Clinical Testing
-
- 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
-
- ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests;
-
- IEC 62133-2 Edition1.0 2017-02 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 - Part 2: Lithium Systems
11
-
- IEC 60601-1-11 Edition 2.0 2015-01, 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 . (General II (ES/EMC))
Clinical Testing
No clinical testing was performed on the device.
The conclusion drawn from the safety testing is that the new devices are substantially equivalent to the predicate devices. Furthermore, the new devices comply with the recognized standards and perform its intended tasks as well as the legally marketed predicate devices.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act 21, CFR Part 807 and based on the Intended Use, Technological Characteristics, Performance data and non-clinical tests performed, the subject device is substantially equivalent and is as safe and as effective as the legally marketed predicate device.