Nu-beca Transcutaneous Electrical Nerve Stimulation

K223151 · Nu-Beca & Maxcellent Co. · NUH · Jul 19, 2023 · Neurology

Device Facts

• Record ID: K223151
• Device Name: Nu-beca Transcutaneous Electrical Nerve Stimulation
• Applicant: Nu-Beca & Maxcellent Co.
• Product Code: NUH · Neurology
• Decision Date: Jul 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The nu-beca Transcutaneous Electrical Nerve Stimulation is indicated for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

Device Story

The nu-beca TENS device is an OTC, battery-powered stimulator used for temporary pain relief in muscles of the lower back and extremities. The device consists of a main stimulator unit (ABS plastic), electrode pads (PET/steel), and conductive gel pads. The user applies the assembled device to the skin; the stimulator generates small electrical pulses via a Pulse Width Modulation (PWM) circuit. Users operate the device via a power button to select one of six frequency modes and use '+' or '-' buttons to adjust intensity across 10 levels. A 15-minute session timer is fixed. Indicator lights (green/orange) provide status on battery, intensity, and electrode adhesion. The device is intended for home use by the patient to manage muscle soreness, providing relief through nerve stimulation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-10), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-5, -10, -23), and performance verification of output waveforms, pulse duration, net charge, and power density. All results met acceptance criteria.

Technological Characteristics

Materials: ABS (stimulator/storage pad), PET/Steel (electrode), ST Gel SR (gel pad). Energy: 3.7V rechargeable lithium battery. Waveform: Asymmetrical biphasic, rectangular. Frequency: 2-80 Hz (6 modes). Output: 10 intensity levels. Connectivity: USB charging. Standards: IEC 60601-1:2012, IEC 60601-1-11:2015, IEC 60601-2-10:2016, IEC 60601-1-2:2014.

Indications for Use

Indicated for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. Intended for use in adults 22 years of age and older.

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

• HIVOX OTC Electrical Stimulator (K211403)

Reference Devices

• Cur Model 1 (K160052)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

July 19, 2023

Nu-Beca & Maxcellent Co. % Diana Sung, MS Assistant Manager of Regulatory Department TaiDoc Technology Corporation B1-7F, No.127, Wugong 2nd Rd. New Taipei City, Wugu District 24888 Taiwan

Re: K223151

Trade/Device Name: nu-beca Transcutaneous Electrical Nerve Stimulation Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: July 19, 2023 Received: July 19, 2023

Dear Diana Sung:

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 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 ([e-mail]) or phone [phone] 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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K223151

#### Device Name

nu-beca Transcutaneous Electrical Nerve Stimulation

Indications for Use (Describe)

The nu-beca Transcutaneous Electrical Nerve Stimulation is indicated for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

| 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

In accordance with the requirements of 21 CFR 807.92, this summary is being provided to serve as the basis for the substantial equivalence determination.

| Company Name | TaiDoc Technology Corporation |
|----------------|----------------------------------------------------------------|
| Address | B1-7F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, |
| | Taiwan 24888 |
| Contact Person | Diana Sung |
| Title | Assistant Manager of Regulatory Department |
| Phone | 886-2-6625-8188 #1158 |
| E-mail | [e-mail] |

### 1. Regulatory Consultant:

### 2. 510(k) Owner Information:

| Company Name | Nu-Beca & Maxcellent Co. |
|----------------|------------------------------------------------------|
| Address | 3F-1, No. 45, Dexing W. Rd., Taipei, Taiwan, 111046. |
| Contact Person | David Tsai |
| Title | President |
| Phone | 886-2-2836-3617 #6000 |
| E-mail | [e-mail] |
| Date Prepared | September 30, 2022 |

### 3. Candidate Device Information:

| Proprietary Name | nu-beca Transcutaneous Electrical Nerve Stimulation |
|-------------------|-----------------------------------------------------|
| Common Name | Transcutaneous Electrical Nerve Stimulation |
| Product Code | NUH |
| Review Panel | Neurology |
| Classification | 2 |
| Regulation Number | 21 CFR §882.5890 |

### 4. Predicate device Information

| Proprietary Name | HIVOX OTC Electrical Stimulator |
|-------------------|---------------------------------|
| Mode Name | FT610-B |
| Manufacturer | HIVOX BIOTEK INC. |
| Product Code | NUH |
| 510(k) Number | K211403 |
| Review Panel | Neurology |
| Classification | 2 |
| Regulation Number | 21 CFR §882.5890 |

{4}------------------------------------------------

| Proprietary Name | Cur Model 1 |
|-------------------|------------------------|
| Mode Name | Mode A (Default Mode) |
| Manufacturer | Thimble Bioelectronics |
| Product Code | NUH, NGX |
| 510(k) Number | K160052 |
| Review Panel | Neurology |
| Classification | 2 |
| Regulation Number | 21 CFR §882.5890 |

#### 5. Reference Device

#### 6. Intended Use

The nu-beca Transcutaneous Electrical Nerve Stimulation is indicated for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

#### 7. Intended Use Population

The nu-beca Transcutaneous Electrical Nerve Stimulation is indicated for different patient populations and is intended for use in Adults Only (22 years of age and older).

#### 8. Device Description

The nu-beca Transcutaneous Electrical Nerve Stimulation consists of following components and accessories:

| Components | Functions | Surface Material |
|-----------------|----------------------------------------------------------------------------------------------|------------------|
| TENS Stimulator | The main unit contains buttons and indicators that<br>release adjustable electrical current. | ABS |
| Electrode Pad | Combine with TENS Stimulator to fix it on user's<br>skin surface. | PET and STEEL |
| nu-beca Gel Pad | Stick the electrode pad connected with TENS<br>Stimulator on user's skin surface. | ST Gel SR |
| Charging Cable | Charge the TENS Stimulator. | PVC |
| Storage Pad | Protect the sticky surface of used nu-beca Gel Pad. | ABS |

Image /page/4/Figure/9 description: The image shows a TENS stimulator and electrode pads. The TENS stimulator is a small device with a power button and plus and minus buttons. The electrode pads are oval-shaped and are attached to the skin. There are two electrode pads on the left and two nu-beca gel pads on the right.

The nu-beca Transcutaneous Electrical Nerve Stimulation release electrical current with adjustable frequencies and voltages to temporarily relief sore and aching muscles. It has only one model: TN0001. The treatment time for one session use is 15 minutes. User can operate the nu-beca Transcutaneous Electrical Nerve Stimulation by following use interfaces.

#### Battery charging

The TENS stimulator is charged by inserting the charging cable into USB charging port, and then plugging the adaptor connected with charging cable into electrical outlet.

{5}------------------------------------------------

#### Assembling

The TENS stimulator, electrode pad and nu-beca Gel Pad should be assembled before application. The nu-beca Gel Pad is stick on the electrode pad to fix the electrode pad in conjunction with TENS stimulator on skin surface. The TENS stimulator is connected with electrode pad by magnet.

#### Application

Apply the assembled nu-beca Transcutaneous Electrical Nerve Stimulation on pain associated sites: lower back, upper and lower extremities (arm and/or leg).

#### Operation

The TENS stimulator is switched-on and switched-off by long pressing the power button. The 13 frequencies of electrical current are configured into mode 6. User can adjust the 6 modes by short pressing the power button. There are 1 to 10 adjustable intensity levels, which represent 10 levels of output voltage. User can adjust level 10 of intensity by pressing the "+" button to increase the output voltage or pressing "—" button to decrease the output voltage.

#### Indicator light display

The TENS stimulator displays indicator lights in green and/or orange color under different conditions.

Green light shows under following conditions:

- · The TENS stimulator is switched-on.
- · The battery is fully charged.

Twinkling green light flashes under following conditions:

- The intensity level is adjusted to the maximum or minimum level. ●
- Twinkling green and orange light flashes under following conditions:
- . The electrode pad is not adhered firmly on skin surface.

Twinkling orange light flashes under following conditions:

- The TENS stimulator is charging.
- . The electricity is about to deplete.

No light shown: The TENS stimulator is switched-off.

#### 9. Principle of Operation

The nu-beca Transcutaneous Electrical Nerve Stimulation device can generate small pulses of electrical current. Delivered these pulses pass through the skin and activated underlying nerves.

The nu-beca Transcutaneous Electrical Nerve Stimulation outputs electrical pulses to specific nerves via gel pad fixed on the intact skin of lower back, upper and lower extremities and powered by rechargeable lithium battery. The purpose is to temporarily relief the pain associated with sore and aching muscles.

The BOOST circuit controls the voltage amplitude by modifying the Pulse Width Modulation (PWM) circuit while the user pressed the "+" or "-" button to adjust the voltage from 1 to 10 intensities. The frequency of output voltage is controlled by modifying the frequency of Pulse Width Modulation (PWM) circuit while the user short pressed the power button to select the 1 to 6 mode, which consists of different frequency combinations.

#### 10. Comparison to Predicate device

- 10.1 Intended Use Comparison
The intended use of the nu-beca Transcutaneous Electrical Nerve Stimulation is the same as the predicate device, it is for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

#### 10.2 Technological Comparison

The nu-beca Transcutaneous Electrical Nerve Stimulation is substantially equivalent to the predicate device in terms of technological characteristics, including their use environment and function.

{6}------------------------------------------------

| Characteristic | Predicate Device | Reference Device | Candidate Device | Remark | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------------|
| | K211403 | K160052 | K223151 | | |
| | HIVOX OTC Electric Stimulator | Cur Model 1, Mode A<br>(Default Mode) | nu-beca Transcutaneous Electrical Nerve<br>Stimulation | | |
| Intended use | The FT610-B is designed for symptomatic<br>relief and management of chronic pain, and<br>for temporary relief of pain associated with<br>sore and aching muscles in the shoulder,<br>waist, back, neck, upper extremities and<br>lower extremities due to strain from exercise<br>or normal household work activities. It is<br>also indicated for temporary relief of pain<br>associated with dysmenorrhea (menstrual<br>cramps) when used with over-the-counter<br>pain medication. In addition, it also provides<br>a heat function intended to temporarily<br>relieve minor aches and pains. | A transcutaneous electrical nerve stimulation<br>(TENS) Mode which is indicated for the<br>symptomatic relief and<br>management of chronic intractable pain, and<br>for temporary relief of pain associated with<br>sore and aching muscles in the<br>shoulder, waist, back, neck, upper<br>extremities (arm) and lower extremities (leg)<br>due to strain from exercise or normal<br>household work activities, and<br>A powered muscle stimulation (PMS) mode<br>which is indicated to improve and facilitate<br>muscle performance in healthy<br>muscles.<br>The CUR Model 1 should be applied to<br>normal, healthy, dry and clean skin of adult<br>patients. | The nu-beca Transcutaneous Electrical Nerve<br>Stimulation is indicated for temporary relief<br>of pain associated with sore and aching<br>muscles in the lower back and upper and<br>lower extremities (arm and/or leg) due to<br>strain from exercise or normal household and<br>work activities. | Refer to #D1 | |
| Classification | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | Same | |
| Product code | NUH | NUH, NGX | NUH | Same | |
| Type of use | OTC | OTC | OTC | Same | |
| EMC | IEC 60601-1-2 Edition 4.0 | IEC 60601-1-2 | IEC 60601-1-2: 2014 | Same | |
| Electrical safety | ANSI/AAMI ES60601-1:2015/(R)2012<br>IEC 60601-1-11 Edition 2.0<br>IEC 60601-2-10 Edition 2.1 | IEC 60601-1<br>IEC 60601-2-10 | IEC 60601-1: 2012<br>IEC 60601-2-10: 2016<br>IEC 60601-1-11: 2015 | Same | |
| Dimension | 113 mm x 70 mm x 9.7 mm | 36mm x 36mm x 8.5mm | 60.5 mm x 44 mm x 11.4 mm | Refer to #D2 | |
| Operation environment | 10 °C ~ 40 °C, 30% ~ 85% R.H. | Not publicly available | 5°C ~ 40 °C (41 °F~104 °F), 15% ~ 90% R.H. | | |
| Storage environment | -10 °C ~ 50 °C, 10%~95% R.H. | Not publicly available | -25 °C~70 °C (-13 °F~158 °F), 10% ~ 90% R.H. | Refer to #D3 | |
| Transport environment | -10 °C~ 50°C, 35%~85% ~ 85% R.H. | Not publicly available | -25 °C~70 °C (-13 °F~158 °F), 10%~90% R.H. | | |
| Power supply | Lithium battery 3V | 3.7V Lithium-Polymer battery (rechargeable) | Lithium battery 3.7 V | Refer to #D4 | |
| Treatment time | 20 minutes fixed | 60 minutes | 15 minutes fixed | Refer to #D5 | |
| Indicator light display | No | Yes | Yes | Refer to #D6 | |
| Parameter | | Predicate Device | Reference Device | Candidate Device | Remark |
| | | K211403 | K160052 | K223151 | |
| | | HIVOX OTC Electric<br>Stimulator | Cur Model 1, Mode A<br>(Default Mode) | nu-beca Transcutaneous<br>Electrical Nerve Stimulation | |
| Waveform | | Symmetrical Biphasic | Biphasic, Asymmetrical | Asymmetrical Biphasic | Similar to K160052<br>Refer to #D7 |
| Shape | | Rectangular | Rectangular | Rectangular | |
| Maximum Output<br>Voltage | @500Ω | 72 ±10% V | 42.6V | 35.0 V | |
| | @2ΚΩ | 112 ±10% V | 85.2V | 55.0 V | |
| | @10ΚΩ | 120 ±10% V | 87.0V | 70.0 V | |
| Maximum Output<br>Current | @500Ω | 144 ±10% mA | 85.1 mA | 75.0 mA | Similar to K160052<br>Refer to #D8 |
| | @2ΚΩ | 56 ±10% mA | 43.1 mA | 27.5 mA | |
| | @10KΩ | 12 ±10% mA | 8.8 mA | 7.0 mA | |
| Pulse Duration | | 100 µSec | 91.7 usec | 100 µSec | Same |
| Frequency | | 100 Hz | 40-130 Hz | 2.0 Hz | Similar to K160052<br>Refer to #D9 |
| | | | | 4.0 Hz | |
| | | | | 5.0 Hz | |
| | | | | 6.0 Hz | |
| | | | | 8.0 Hz | |
| | | | | 10.0 Hz | |
| | | | | 16.0 Hz | |
| | | | | 20.0 Hz | |
| | | | | 32.0 Hz | |
| | | | | 40.0 Hz…