Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard electrical stimulation technology and do not mention any AI or ML components or capabilities.

Therapeutic

Yes
The device is indicated for symptomatic relief and management of chronic pain, post-surgical and post-traumatic pain, and pain associated with sore and aching muscles, which are all therapeutic indications. It also aims to increase local blood circulation and facilitate muscle performance.

Diagnostic

No

The device is described as an electrical nerve and muscle stimulator for symptomatic relief and muscle conditioning, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a portable battery-operated electrical stimulation device with hardware components like channels, lead wires, electrodes, buttons, dials, jacks, and an LCD display.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The description and intended use clearly state that this device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator. It works by applying electrical stimulation to the body's surface for pain relief and muscle conditioning.
No Mention of Samples: There is no mention of the device being used to test samples taken from the body.
Anatomical Site: The anatomical sites listed are external parts of the body where the electrodes are applied.

Therefore, this device falls under the category of external electrical stimulators, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Transcutaneous Electrical Nerve Stimulation:

For symptomatic relief and management of chronic pain
For adjunctive treatment in the management of post-surgical and post-traumatic pain
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 and normal household and work activities

Powered Muscle Stimulator

To temporarily increase local blood circulation in healthy muscles
For muscle conditioning by stimulating healthy muscle in order to improve or facilitate muscle performance

Product codes

NUH, NGX

Device Description

The HBOTC is an OTC electrical nerve and muscle stimulator indicated for symptomatic relief and management of chronic pain as well as muscle conditioning and increasing local blood flow. The HBOTC consists of a portable battery-operated electrical stimulation device with two channels, two sets of lead wires, six packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons for selecting the desired frequency and a dial to control the intensity of the signal. The stimulator is also supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display.

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), and lower extremities (leg)

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

Non-clinical performance tests were conducted including Software Validation, IEC 60601-1 (2012), IEC 60601-1-11 (2015), and IEC 60601-2-10 (2012)/Amendment 1 2001. The data shows that the HBOTC is substantially equivalent to the predicates as a powered muscle stimulator and transcutaneous electrical nerve stimulator for pain relief.

Key Metrics

Not Found

Predicate Device(s)

K131910, K112485, K103738, K102051

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a stylized eagle above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 15, 2016

HB Medical, Inc. % Robyn Scopis CEO Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92831

Re: K160255

Trade/Device Name: HBOTC Muscle And Nerve Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: August 15, 2016 Received: August 16, 2016

Dear Robyn Scopis:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J.Hoffmann -A

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160255

Device Name HBOTC Muscle and Nerve Stimulator

Indications for Use (Describe)

Transcutaneous Electrical Nerve Stimulation:

1. For symptomatic relief and management of chronic pain
1. For adjunctive treatment in the management of post-surgical and post-traumatic pain

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 and normal household and work activities

Powered Muscle Stimulator

1. To temporarily increase local blood circulation in healthy muscles
1. For muscle conditioning by stimulating healthy muscle 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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510(k) SUMMARY K160255 510(k) Owner HB Medical 5702 Bolsa Ave. Huntington Beach, CA 92649 Phone: (714) 330-7333 Facsimile: (714) 500-4092 Contact person Robyn Scopis Regulatory Specialists, Inc. 1801 Edgecliff Drive Fullerton, CA 92831 Phone: 949.262.0411 Fax: 949.552.2821 Email: robyn@regulatoryspecialists.com Preparation Date September 13, 2016 Primary Product Code: NUH Common Name Transcutaneous electrical nerve stimulator for pain relief Trade Name HBOTC Muscle and Nerve Stimulator stimulator, nerve, transcutaneous, Classification Name over-the-counter Regulation 882.5890 Class Class II Panel Neurology Secondary Product Code: NGX Common Name Powered muscle stimulator HBOTC Muscle and Nerve Stimulator Trade Name Classification Name stimulator, muscle, powered, for muscle conditioning Regulation 890.5850 Class Class II Panel Physical Medicine Primary Predicate K131910 Secondary Predicate K112485 Third Predicate K103738 Fourth Predicate K102051

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Description

The HBOTC is an OTC electrical nerve and muscle stimulator indicated for symptomatic relief and management of chronic pain as well as muscle conditioning and increasing local blood flow. The HBOTC consists of a portable battery-operated electrical stimulation device with two channels, two sets of lead wires, six packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons for selecting the desired frequency and a dial to control the intensity of the signal. The stimulator is also supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display.

Intended Use

The HBOTC is intended for use as a nerve and muscle stimulator for patients wanting symptomatic relief and management of chronic pain as well as muscle conditioning and increasing local blood flow.

Indications for Use

Transcutaneous Electrical Nerve Stimulation:

For symptomatic relief and management of chronic pain
For adjunctive treatment in the management of post-surgical and posttraumatic pain
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 and normal household and work activities

Powered Muscle Stimulator

To temporarily increase local blood circulation in healthy muscles
For muscle conditioning by stimulating healthy muscle in order to improve or facilitate muscle performance

Comparison of Technological Characteristics to Predicate Devices

The predicates and the HBOTC were compared in the following areas and found to have minor different technological characteristics. The following differences have been determined to not impact the safety and effectiveness of the HBOTC:

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| 510(k) Number | Subject Device | Primary
Predicate | Secondary
Predicate | Third Predicate | Fourth Predicate | Regulated Current or
Regulated Voltage | Regulated
Voltage | Regulated
Voltage | Regulated
Voltage | Regulated
Voltage | Regulated
Voltage |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|---------------------------------------------------|
| | HBOTC
K160255 | MPP
K131910 | H4
K112485 | H4
K103738 | Pain Buddy
K102051 | Software/firmware/mi
croprocessor | Yes | Yes | Yes | Yes | Yes |
| Power Source | Ni-MH
rechargeable
battery (7.2 V) | Ni-MH
rechargeable
battery (7.2 V) | Ni-MH
rechargeable
battery (7.2 V) | Ni-MH
rechargeable
battery (7.2 V) | Two 1.5-Volt
AAA disposable
cells (3 V) | Automatic Overload
Trip | No | No | No | No | No |
| Intended Use | Transcutaneous
Electrical Nerve
Stimulation:

For
symptomatic
relief and
management of
chronic pain
For adjunctive
treatment in the
management of
post-surgical and
post-traumatic
pain
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 and
normal
household and | The MPP is 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
and normal
household and
work activities.
The MPP is
intended for
muscle
conditioning by
stimulating
muscle in order
to improve or
facilitate muscle
performance | The H-Wave H4
is indicated for
the treatment of
chronic pain,
acute pain, post-
surgical pain,
and temporary
pain. | 1. Relaxation of
muscle spasms;
Prevention or
retardation of
disuse atrophy;
Increasing
local blood
circulation;
Muscle re-
education;
Immediate
post-surgical
stimulation of
calf muscles to
prevent venous
thrombosis;
Maintaining
or increasing
range of motion. | TENS
stimulation is
used for
symptomatic
relief and
management of
chronic pain
and/or as an
adjunctive
treatment in the
management of
post-surgical
and post-
traumatic pain. | Automatic No-Load
Trip | Yes | Yes | Yes | Yes | Yes |
| | work activities | | | | | Automatic Shut Off? | No | No | No | No | No |
| | Powered Muscle
Stimulator
To temporarily
increase local
blood circulation
in healthy
muscles
For muscle
conditioning by
stimulating
healthy muscle in
order to improve
or facilitate
muscle
performance | | | | | Patient Override
Control | Yes | Yes | Yes | Yes | Yes |
| Line Current Isolation | Yes (battery
operated) | Yes (battery
operated) | Yes (battery
operated) | Yes (battery
operated) | Yes (battery
operated) | Indicator Display | | | | | |
| Patient Leakage Current | | | | | | On/ Off Status | Yes | Yes | Yes | Yes | Yes |
| Normal Condition | 0 | 0 | 0 | 0 | 0 | Low Battery | Yes | Yes | Yes | Yes | Yes |
| Single fault condition | 0 | 0 | 0 | 0 | 0 | Voltage/ Current Level | Yes | Yes | Yes | Yes | Yes |
| Average DC current
through electrodes
when device is on but
no pulses are being
applied (μΑ) | 0 | 0 | 0 | 0 | 0 | Weight | 1.6 lb | 1.6 lb | 1.6 lb | 1.6 lb | 1.9 oz |
| Number of output
modes | 1 | 1 | 1 | 0
1 | 1 | Dimensions | 7" x 4.5" x 1.5" | 7" x 4.5" x 1.5" | 7" x 4.5" x 1.5" | 7" x 4.5" x 1.5" | 4.9" x 1.4" x 0.6" |
| Number of output
channels | 2 | 2 | 2 | 2 | 1 | Housing materials and
constructions | ABS plastic
housing fastened
with screws | ABS plastic
housing fastened
with screws | ABS plastic
housing fastened
with screws | ABS plastic
housing fastened
with screws | ABS plastic
housing
fastened with
screws |
| synchronous or
alternating | alternating | alternating | alternating | alternating | alternating | Waveform | biphasic | biphasic | biphasic | biphasic | biphasic |
| Method of Channel
Isolation | galvanic | galvanic | galvanic | galvanic | galvanic | Frequency | 1-70 Hz | 1-70 Hz | 1-70 Hz | 1-70 Hz | 8-80 Hz |
| Beat Frequency | N/A | N/A | N/A | N/A | N/A | | | | | | |
| Shape | spike with
exponential
decay | spike with
exponential
decay | spike with
exponential
decay | spike with
exponential
decay | Asymmetrical Bi-
Phasic
Rectangular | | | | | | |
| Maximum Output
Voltage @500Ω | 21V | 21V | 21V | 21V | 29V | | | | | | |
| Maximum Output
Voltage @2kΩ | 56v | 56v | 56v | 56v | 34V | | | | | | |

6

7

8

| Maximum Output

Voltage @10kΩ	100V	100V	100V	100V	36V
Maximum Output
Current @500Ω	42 mA	42 mA	42 mA	42 mA	60 mA
Maximum Output
Current @2kΩ	28 mA	28 mA	28 mA	28 mA	17mA
Maximum Output
Current @10kΩ	10 mA	10 mA	10 mA	10 mA	4mA
Pulse Width	5 ms @ 1 k ohms	5 ms @ 1 k ohms	5 ms @ 1 k ohms	5 ms @ 1 k ohms	160 µs
Net Charge	o (equal positive
and negative
pulses)	o (equal positive
and negative
pulses)	o (equal positive
and negative
pulses)	o (equal positive
and negative
pulses)	unknown
Maximum Phase
Charge @500Ω	16.8 µC	16.8 µC	16.8 µC	16.8 µC	unknown
Maximum Current
Density @500Ω	2 mA/cm²	2 mA/cm²	2 mA/cm²	2 mA/cm²	unknown
Maximum Power
Density @500Ω	0.042 W/cm²	0.042 W/cm²	0.042 W/cm²	0.042 W/cm²	unknown
Burst Mode
Pulses per burst	N/A	N/A	N/A	N/A	unknown
Burst Mode
Bursts per second	N/A	N/A	N/A	N/A	unknown
ON Time (seconds)	N/A	N/A	N/A	N/A	unknown
OFF Time (seconds)	N/A	N/A	N/A	N/A	unknown

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The following non-clinical performance tests were conducted:

Software Validation

IEC 60601-1 (2012): Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-11 (2015): 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.

IEC 60601-2-10 (2012)/Amendment 1 2001, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators.

Conclusions from non-clinical performance data

After performing non-clinical performance studies, the data shows that the HBOTC is substantially equivalent to the predicates as a powered muscle stimulator and transcutaneous electrical nerve stimulator for pain relief.