Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)

K223428 · Shenzhen Leqing Medical Instrument Co., Ltd. · NUH · May 8, 2023 · Neurology

Device Facts

• Record ID: K223428
• Device Name: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
• Applicant: Shenzhen Leqing Medical Instrument Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: May 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities. Note1: The electrode on the stimulator is used in the waist. Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg, Heating: To be used for temporary relief of minor aches and pains. Models: uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.

Device Story

Portable, battery-powered TENS device; provides electrical pulse stimulation and heating. Inputs: user-selected stimulation modes/levels and heat settings via controller or wireless remote. Operation: device controller generates symmetric biphasic pulsed electrical waveforms and heat (max 43°C) through built-in metal electrodes or external gel electrodes. Used in home/clinic settings by patients for muscle pain relief. Output: electrical stimulation to muscles/nerves; heat for comfort. Healthcare providers/patients use output to manage pain; device provides temporary relief of sore/aching muscles. Includes rechargeable battery, adapter, and gel electrodes.

Clinical Evidence

No clinical data. Bench testing only: biocompatibility (ISO 10993-5, -10), electrical safety/EMC (IEC 60601-1, -1-2, -1-11, -2-10), software verification/validation, and performance verification (waveform/output testing, electrode shelf-life per ASTM F1980-07).

Technological Characteristics

Materials: ABS/PC plastic enclosure, metal electrodes, conductive hydrogel. Energy: 7.4V/3.7V rechargeable battery. Waveform: Pulsed, symmetric, biphasic (rectangular). Connectivity: Wireless remote control. Sterilization: Not specified. Software: Microprocessor-controlled, moderate level of concern. Standards: IEC 60601 series, ISO 10993.

Indications for Use

Indicated for temporary relief of pain in shoulder, waist, back, neck, arm, and leg muscles due to exercise or household/work strain; also indicated for temporary relief of minor aches and pains via heating function. For OTC use.

Regulatory Classification

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.

Predicate Devices

• Heating Lumbar Therapy Cushion/AST-622 (K211942)
• Health Expert Electronic Stimulator/AST-300L (K190783)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 8, 2023

Shenzhen Leqing Medical Instrument Co., Ltd % Rain Yip Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm2401, ZhenYe International Center, No.3101-90 Qianhai Road Nanshan District Shenzhen, Guangdong 518000 China

Re: K223428

Trade/Device Name: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A. LO-9525B. uNeck-9512A. uNeck-9515A. uNeck-9517B. uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, IRT Dated: January 17, 2023 Received: April 12, 2023

Dear Rain Yip:

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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

# Amber T. Ballard -S

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 Ouality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K223428

#### Device Name

Electronic Stimulator (Models: uLumb-9530A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)

#### Indications for Use (Describe)

Models: uLumb-9530A、uLumb-9531A、uLumb-9532A、uLumb-9533A、LQ-9525B:

Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.

Notel : The electrode on the stimulator is used in the waist.

Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg,

Heating: To be used for temporary relief of minor aches and pains.

Models: uNeck-9512A, uNeck-9517B, uNeck-9517B, uNeck-9519A, uNeck-9521A, uNeck-9529A, LO-9535 A: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.

| 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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# 510(k) Summary

# "510(k) Summary" as required by 21 CFR Part 807.92.

# Date: May 8, 2023

#### I. Submitter

Shenzhen Leqing Medical Instrument Co.,LTD 2-3/F, Building D, No.31 Fangkeng Road, Longgang, Shenzhen, Guangdong, China Post code: 518000 Tel .: [phone]

Shaodong Wang Management Representative Tel: [phone] Email: [e-mail]

## II. Device

Trade Name: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9517B, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck- 9529A, LQ-9535A) Common Name: Transcutaneous electrical nerve stimulator Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Regulatory Class: II Product Code: NUH. IRT Regulation Number: 21 CFR 882.5890

## III. Predicate Device

Primary Predicate device: 510(k) number: K211942 Manufacturer: Shenzhen OSTO Technology Company Limited Trade name: Heating Lumbar Therapy Cushion/AST-622 Product code: NGX, NUH, IRT Approval date: December 13, 2021

Secondary predicate device: 510(k) number: K190783 Manufacturer: Shenzhen OSTO Technology Company Limited Trade name: Health Expert Electronic Stimulator/AST-300L Product code: NUH, NGX Approval date: March 14, 2020

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## IV. Device Description

The Electronic Stimulator is a portable and battery-powered TENS device with multiple models, offering both electrical pulse stimulation and heating function in one device.

The device consists of a controller that has built-in metal electrodes and accessories of a remote control, an adapter, and/or a pair of gel electrodes, an external connection coupling. The external connection coupling is used to connect the gel electrodes to the device. All models are powered by internal rechargeable battery and charged by the adapter. And all accessories, including the remote control, adapter, gel electrodes, external connection coupling can only be changed or replaced by a qualified person.

The functions of the device are controlled by the device controller and the remote control, where the remote control establishes a connection with the device controller through wireless signals. The device has five stimulation modes and one heating mode, through the metal electrodes to provide users with waist or nape stimulation and heat generation to warm and comfortable waist or nape muscles. And the heating function is controlled by a heat/temperature key and can only be run on metal electrodes, it is cannot be operated alone. The heating temperature does not exceed 43 degrees Celsius at the same time. In addition, the device is also equipped with a pair of gel electrodes, which can be used to stimulate different parts of the body (shoulder, waist, back, back of neck (nape), arm, and leg).

The device has 13 models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A, the 13 models differ in appearance, size, battery capacity, number of keys on the stimulator, the specification of electrodes equipped, and some output parameters, the details can refer to the "Model list form" of the Device Description file in this application.

## V. Indications for Use

Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.

Note1: The electrode on the stimulator is used in the waist.

Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains.

Model): uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A:

Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.

## VI. Comparison of Technological Characteristics With the Predicate Device

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Compare with predicate devices, the Electronic Stimulator is very similar in the same technical characteristics, features, specifications, materials, mode of operation, intended use, and the applicable standards. The differences between subject device and the predicate devices do not raise new questions of safety or effectiveness.

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| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | | |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k) number | Pending | K190783 | K211942 | | |
| Device name | Electronic Stimulator | Health Expert Electronic Stimulator | Heating Lumbar Therapy Cushion | | |
| Model(s) | uLumb-9530A,<br>uLumb-9531A,<br>uLumb-9532A,<br>uLumb-9533A, LQ-<br>9525B | uNeck-9512A,<br>uNeck-9515A,<br>uNeck-9517B,<br>uNeck-9518A,<br>uNeck-9519A,<br>uNeck-9521A,<br>uNeck-9529A, LQ-<br>9535A | AST-300L | AST-622 | |
| Manufacturer | Shenzhen Leqing Co.,LTD | Medical Instrument | Shenzhen OSTO Technology Company Limited | Shenzhen OSTO Technology Company Limited | |
| Indication for<br>use/Intended use | Electrical simulation:<br>To be used for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist, back,<br>back of neck, arm, and<br>leg, due to strain from<br>exercise or normal<br>household and work<br>activities.<br>Notel: The electrode<br>on the stimulator is<br>used in the waist.<br>Note2: The additional<br>gel patch is used in<br>shoulder, waist, back,<br>back of neck, arm | Electrical simulation:<br>To be used<br>for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the back of<br>neck, due to strain<br>from exercise or<br>normal household and<br>work activities.<br>Heating: To be used<br>for temporary relief of<br>minor aches and<br>pains. | PMS (Mode 1~8)<br>It is intended to stimulate healthy<br>muscles in order to improve and<br>facilitate muscle performance.<br>TENS (Mode 9~25)<br>To be used for temporary relief of pain<br>associated with sore and aching<br>muscles in the shoulder, waist, back,<br>back of the neck, arm, leg, and foot due<br>to strain from exercise or normal<br>household work activities by applying<br>current to stimulate nerve. | PMS(1 ~ 2): It is intended to stimulate<br>healthy muscles in order to improve and<br>facilitate muscle performance.<br>TENS(3 ~ 5): To be used for temporary<br>relief of pain associated with sore and<br>aching muscles in the shoulder, waist,<br>back, arm and leg due to strain from<br>exercise or normal household work<br>activities by applying current to<br>stimulate nerve.<br>Heating: The Heating Lumbar Therapy<br>Cushion is intended for temporary relief<br>of minor aches and pains. | |
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | | |
| | and leg.<br>Heating: To be used<br>for temporary relief of<br>minor aches and<br>pains. | | | | |
| Location for use | OTC | OTC | OTC | | |
| Power source(s) | Powered by the<br>internal rechargeable<br>battery, 7.4Vd.c.,<br>2600mAh | Powered by the<br>internal rechargeable<br>battery, 3.7Vd.c.,<br>700mAh (uNeck-<br>9512A, uNeck-<br>9515A, uNeck-<br>9517B, uNeck-<br>9518A, uNeck-<br>9519A)<br><br>Powered by the<br>internal rechargeable<br>battery, 3.7Vd.c.,<br>$280mAh*2$ (uNeck-<br>9521A)<br><br>Powered by the<br>internal rechargeable<br>battery, 3.7Vd.c.,<br>1200mAh (uNeck-<br>9529A, LQ-9535A) | Adaptor Input: 100-240Vac, 50-60Hz,<br>0.1A, Output: 5Vdc, 2A<br>Unit Input: 5Vdc, 2A | Power by adapter, 100-240VAC, 50-60Hz, Output: 5Vdc, 2A<br>Unit Input: 5Vdc, 2A | |
| Charged by the<br>external adapter: | Charged by the<br>external adapter: | | | | |
| Comparison items | Subject device | | Secondary Predicate devices | Primary predicate device | |
| | Input: 100-240Va.c.,<br>50/60Hz, 0.4A Max.<br>Output: 5.0Vd.c.,<br>2.0A | Input: 100-240Va.c.,<br>50/60Hz, 0.4A Max.<br>Output: 5.0Vd.c.,<br>1.0A | | | |
| -Method of Line<br>Current Isolation | Not applicable | | Type BF Applied Part | Type BF Applied Part | |
| -Patient<br>Leakage<br>Current | NC<br>(μA) | <50μA | AC: 54.5μA<br>DC: 0.5μA | AC: 54.5μA<br>DC: 0μA | |
| | SFC<br>(μA) | <100μA | AC: 120μA<br>DC: 0.6μA | AC: 13.4μA<br>DC: 0μA | |
| Average DC current<br>through electrodes<br>when device is on but<br>no pulses are<br>being applied (μA) | 0μA | | <0.01μA | Not publicly available | |
| Function and design | Electrical stimulation and heat | | Electrical stimulation and heat | Electrical stimulation and heat | |
| Function output<br>patterns | Electrical stimulation only<br>Electrical stimulation + Heat simultaneously | | Electrical stimulation only<br>Alternating combinations of Electrical<br>stimulation and Heat | Electrical stimulation only<br>Heat only<br>Electrical stimulation + Heat<br>simultaneously | |
| Heating setting | (+/-2°C)<br>Level LOW: 39°C<br>Level HIGH: 41°C | (+/-2°C)<br>Level LOW: 39°C<br>Level HIGH: 41°C | Adjustable<br>Heating temperature is from 30~40℃ | Level 1: 37°C<br>Level 2: 41°C<br>Level 3: 43°C | |
| Maximum<br>temperature setting | 43°C | | 40°C | 43°C | |
| Number of Output<br>Modes | Electrical simulation: 5 modes<br>Heat: 1 mode | | 25 modes | For stimulation: 5 modes<br>For heating: 1 mode | |
| Number of Output<br>Levels | Electrical simulation:<br>60 levels<br>Heat: 2 levels | Electrical simulation:<br>30 levels<br>Heat: 2 levels | 99 levels | For stimulation: 50 levels<br>For heating: 3 levels | |
| Number of Output | 2 channels | 1 channel | 2 channels | 1 channel | |
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | | |
| Channels | | | | | |
| Number<br>of Output<br>Channels | Synchronous or<br>Alternating? | Alternating | Synchronous | Synchronous | |
| | Method of<br>Channel<br>Isolation | Potential transformer,<br>RELAY, Software<br>isolation | Voltage Transform<br>Isolation<br>"Body+" and "Body-" buttons for<br>body channel, "Sole+" and "Sole-"<br>buttons for feet channel | Not applicable | |
| Regulated Current or<br>Regulated Voltage? | | Regulated Voltage | Voltage Control | Regulated Voltage | |
| Software/Firmware/<br>Microprocessor<br>Control? | | Yes | Yes | Yes | |
| Automatic Overload<br>Trip? | | No | No | No | |
| Automatic No-Load<br>Trip? | | No | No | No | |
| Automatic Shut Off? | | Yes | Yes | Yes | |
| User<br>Control? | Override | No | Yes | Yes | |
| | On/Off<br>Status? | Yes | Yes | Yes | |
| Indicator<br>Display | Low<br>Battery? | Yes | No | No…