K Number

Device Name

HEALTH EXPERT ELCTRONIC STIMULATOR

Manufacturer

SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED

Date Cleared

2014-11-12

(324 days)

Product Code

NUH NGX

Regulation Number

882.5890

Intended Use

PMS (Mode 1~8) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 9~25) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Device Description

Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities. Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation, as well as certain non-electrical rolling massage through one massage roller. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys. The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode. The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device. The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K121719, K122744

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard TENS/PMS device with pre-set modes and manual intensity control. There is no mention of adaptive algorithms, learning capabilities, or any terms associated with AI/ML. The performance studies focus on electrical safety, EMC, biocompatibility, usability, and software verification against established standards and guidance documents, not AI/ML performance metrics.

Therapeutic

Yes
The device is described as both a Transcutaneous Electronic Nerve Stimulator (TENS) and a Powered Muscle Stimulator (PMS), with intended uses for pain relief and muscle performance improvement, which fall under the definition of therapeutic devices.

Diagnostic

The device description and intended use state that it is for stimulation and pain relief, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a "portable and adapter powered multifunctional device" with physical components like electrode pads, a main unit, a display screen, buttons, and accessories like electrode wires and an adapter. It also mentions non-electrical rolling massage. This indicates it is a hardware device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is for stimulating healthy muscles to improve performance (PMS) and for temporary pain relief associated with sore and aching muscles (TENS). These are therapeutic uses, not diagnostic uses.
Device Description: The description details how the device applies electrical pulses to the skin to stimulate nerves and muscles. This is consistent with a therapeutic device, not a device that analyzes samples from the body to diagnose a condition.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a disease or condition.

Therefore, the Health Expert Electronic Stimulator is a therapeutic medical device, specifically a TENS and PMS device, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

PMS (Mode 18)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 925)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist. back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Product codes (comma separated list FDA assigned to the subject device)

NUH, NGX

Device Description

Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation, as well as certain non-electrical rolling massage through one massage roller.

The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.

The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.

The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.

The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

shoulder, waist, back, back of the neck, arm, leg, and foot

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Health Expert Electronic Stimulator has been evaluated the safety and performance by lab bench testing as following:

Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards
Electromagnetic compatibility test according to IEC 60601-1-2 standard
Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
Usability test according to IEC 62366 standard
Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning

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.

K121719, K122744

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.

Not Found

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

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are drawn with thick, curved lines, creating a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

November 12, 2014

Shenzhen OSTO Technology Company Limited Li Yang, General Manager No.43 Longfeng Road Xinsheng Community, Longgang Street Longgang District, Shenzhen City Guangdong Province CHINA

Re: K133929

Trade/Device Name: Health Expert Electronic Stimulator, Model AST-300C and AST-300D Regulation Number: 21 CFR 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: NUH, NGX Dated: October 07, 2014 Received: October 10, 2014

Dear LiYang:

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. Isting 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

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Felipe Aquel -S

for

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

Enclosure

Indications for Use

510(k) Number (if known) K133929

Device Name

Health Expert Electronic Stimulator, Model: AST-300C and AST-300D

Indications for Use (Describe)

PMS (Mode 1~8)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Sponsor:	Shenzhen OSTO Technology Company Limited
Subject Device:	Health Expert Electronic Stimulator, Model: AST-300C and AST-300D
File No.:	510(k) submission report (V1.0)
Chapter 5	510(k) Summary

Chapter 5. 510(k) Summary

510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: Shenzhen OSTO Technology Company Limited �
Establishment Registration Number: Applying �
Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District, � Shenzhen City, Guangdong Province, China
� Tel: +86-755-29769546
� Fax: +86-755-29769540
Contact Person: Li Yang (General Manger) �
Email: annaosto@163.com �

Subject Device Information 2.

Health Expert Electronic Stimulator � Trade Name:
ll
Electronic Stimulator Common Name: �
Stimulator, Nerve, Transcutaneous, Muscle, Powered, For � Classification name: Muscle Conditioning, Over-The-Counter
Neurology, Physical Medicine � Review Panel:
NUH, NGX � Product Code:
Regulation Class: �
882.5890, 890.5850 Requlation Number: �

Predicate Device Information 3.

Sponsor	Hong Qiangxing (Shenzhen) Electronics Limited	Prospera Cprporation
Device Name and Model	SM TENS & PMS
Model: SM9128	Prospera OTC TENS Electronic Pulse Massager
Model: PL029
510(k) Number	K121719	K122744
Product Code	NUH, NGX	NUH, NGX
Regulation Number	882.5890, 890.5850	882.5890
Regulation Class	II	II

Sponsor:	Shenzhen OSTO Technology Company Limited
Subject Device:	Health Expert Electronic Stimulator, Model: AST-300C and AST-300D
File No.:	510(k) submission report (V1.0)
Chapter 5	510(k) Summary

4. Device Description

The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.

The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.

5. Intended Use / Indications for Use

PMS (Mode 1~8)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 9~25)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist. back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

6. Test Summary

Health Expert Electronic Stimulator has been evaluated the safety and performance by lab bench testing as following:

� Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards
◆ Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
◆ Usability test according to IEC 62366 standard
� Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
� The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning

Sponsor:	Shenzhen OSTO Technology Company Limited
Subject Device:	Health Expert Electronic Stimulator, Model: AST-300C and AST-300D
File No.:	510(k) submission report (V1.0)
Chapter 5	510(k) Summary

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Electronic Muscle Stimulator is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of

Comparison	Subject Device	Predicate Device		Remark
Device Name and
Model	Health Expert Electronic
Stimulator
Model: AST-300C and
AST-300D	SM TENS & PMS
Model: SM9128	Prospera OTC TENS
Electronic Pulse
Massager
Model: PL029	--
510(k) Number	Applying	K121719	K122744	--
Intended Use &
Indications for
Use	PMS (Mode 1~8)
It is intended to
stimulate healthy
muscles in order to
improve and facilitate
muscle performance.
TENS (Mode 9~25)
To be used for
temporary relief of pain
associated with sore and
aching muscles in the
shoulder, waist, back,
back of the neck, arm,
leg, and foot due to
strain from exercise or
normal household work
activities by applying
current to stimulate
nerve.	TENS (Mode 1, 3, 4, 5, 6):
To be used for temporary
relief of pain associated
with sore and aching
muscle in the shoulder,
waist, back, neck, upper
extremities (arm), and
lower extremities (legs)
due to strain from
exercise or normal
household work activities.
PMS (Mode 1, 2, 3, 6):
It is intended to be used to
stimulate healthy muscle
in order to improve and
facilitate muscle
performance.	To be used for
temporary relief of pain
associated with sore
and aching muscle in
the shoulder, waist,
back, neck, upper
extremities (arm), and
lower extremities (legs)
due to strain from
exercise or normal
household work
activities.	SE
Basic Unit Characteristics
Power Source(s)	Adaptor Input: 100-
240Vac, 50-60Hz, 0.1A
Output: 5Vdc, 1A
Unit Input: 5Vdc, 1A	DC 3.7V Lithium Battery	DC 3V Lithium
Battery	SE
Note1
-Method of Line
Current Isolation	Type BF Applied Part	Type BF Applied Part	Type BF Applied Part	SE

Sponsor:	Shenzhen OSTO Technology Company Limited
Subject Device:	Health Expert Electronic Stimulator, Model: AST-300C and AST-300D
File No.:	510(k) submission report (V1.0)
Chapter 5	510(k) Summary

Elements of Comparison	Subject Device	Predicate Device	Remark
Patient Leakage Current	NC AC: 54.5µA, DC: 0.5µA	2.0μΑ	2.0μΑ SE Note 1
	SFC AC:120.0µA, DC: 0.6μΑ