The device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief of chronic (long term) intractable pain, and (2) adjunctive treatment in the management of post-surgical and post-traumatic pain problems.

The EMS programs of HIVOX Electric Stimulator TENS & EMS, HD2:

The device is an electrical powered muscle stimulator indicated for medical purpose to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy.

Device Description

The HIVOX Electric Stimulator TENS & EMS, HD2 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activated underlying nerves. The relief from chronic and acute pain that the HD2 can provide results from this electrical stimulation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HIVOX Electric Stimulator TENS & EMS, HD2:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, the "acceptance criteria" are implied by substantial equivalence to a predicate device. The performance is assessed against recognized medical device standards and compared to the predicate device's specifications.

Acceptance Criteria (Implied by Substantial Equivalence and Standards)	Reported Device Performance (HIVOX HD2)
Safety Standards Adherence:
- Medical electrical equipment Part 1. General requirements for safety (IEC/EN 60601-1)	- Tested in accordance with IEC/EN 60601-1:1996
- Medical electrical equipment, Part 2. Electromagnetic compatibility (IEC/EN 60601-1-2)	- Tested in accordance with IEC/EN 60601-1-2:2004
- Medical electrical equipment Part 2. Safety of Nerve and Muscle Stimulators (IEC/EN 60601-2-10)	- Tested in accordance with IEC/EN 60601-2-10:1987
- Electrical safety for accessories (electrodes, patient cables)	- 510(k) electrodes specified; patient cable utilizes shrouded connectors to meet lead wire safety requirements.
- System level testing (waveform testing)	- System-level testing, including waveform testing, was performed.
Functional Equivalence to Predicate Device (MEDIHIGHTEC K082514):
- Ability to provide TENS programs for pain relief (symptomatic relief of chronic intractable pain, adjunctive treatment for post-surgical/post-traumatic pain)	- Indicated for the same TENS uses: (1) Symptomatic relief of chronic (long term) intractable pain, and (2) adjunctive treatment in the management of post-surgical and post-traumatic pain problems.
- Ability to provide EMS programs for muscle stimulation (relaxing spasms, increasing circulation, preventing venous thrombosis, muscle re-education, maintaining/increasing range of motion, preventing disuse atrophy)	- Indicated for the same EMS uses: (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy.
- Similar technical specifications (e.g., output characteristics, channels, controls, safety features)	- Detailed comparison table provided (Page 2), highlighting similarities and differences, with the conclusion that the new device is "as safe and effective as, and the function in a manner equivalent to the predicate device." Key differences in electrical characteristics (e.g., max output voltage/current, pulse width, frequency, max phase charge, max current/power density) were presented, but deemed acceptable for substantial equivalence. Other features like channels, synchronous/reciprocal operation, computerized capabilities, patient override, burst mode, housing, product standards, timer, and low battery indicator are compared.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of this 510(k) submission. This is a premarket notification primarily based on non-clinical performance testing and comparison to a predicate device, rather than a clinical trial with a specific test set of patients.
Data Provenance: The performance data primarily comes from non-clinical tests conducted by HIVOX Biotek Inc. related to the specified IEC/EN standards. The data is retrospective in the sense that it's based on tests performed on the device itself, but it does not involve human subject data or a specific "test set" of patient cases. The country of origin of the device manufacturer and the testing company (implied) is Taiwan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts/Qualifications: Not applicable. There was no "test set" requiring expert ground truth in the traditional sense of clinical opinion or diagnosis. The ground truth for electrical and performance characteristics is established by the relevant engineering and medical device standards (IEC/EN). Regulatory bodies (like the FDA) review compliance with these standards and the comparison data.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as there was no test set requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No. This device is an electrical stimulator (TENS & EMS), not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case comparative effectiveness study with human readers assisting AI or vice-versa is entirely irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This is not an algorithm or AI device. Its performance is inherent in its physical and electrical characteristics as measured against standards.

7. The Type of Ground Truth Used

Ground Truth: The "ground truth" for this device's performance and safety is derived from:
- International/National Standards: Compliance with IEC/EN 60601-1, IEC/EN 60601-1-2, and IEC/EN 60601-2-10.
- Predicate Device Specifications: The established safety and effectiveness profile of the legally marketed predicate device (MEDIHIGHTEC TENS/EMS Combo, K082514). The comparison aims to demonstrate that the new device meets or exceeds the critical performance aspects and safety features of the predicate.
- Engineering and Electrical Measurements: Verifiable data from tests on the device's electrical output, waveforms, and physical construction.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not employ machine learning or AI, so there is no concept of a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the word "HIVOX" in a bold, sans-serif font, followed by the registered trademark symbol. To the right of the word is a stylized graphic that resembles a plus sign or cross, composed of interconnected squares or blocks. The graphic has a three-dimensional appearance due to the shading on some of the blocks.

HIVOX BIOTEK INC

8/F, No.98 Shingde Road Sanchong City Taipei 241 Taiwan ROC Fax: +886 2 8511 2669 Phone: +886 2 8511 2668

SUMMARY OF SAFETY AND EFFECTIVENESS for TENS & EMS

510(k): K092448

DATE OF SUBMISSION

MAR 3 0 2010

SUBMISSION:	July 27, 2009
SUBMITTER:	HIVOX BIOTEK INC.
	8F, No.98, Shinde Road,
	Sanchong City, Taipei, 24158, TAIWAN
	TEL: 886-2-85112668 FAX:886-2-85112669
	Email: ceirs.jen@msa.hinet.net

ESTABLISHMENT REGISTRATION NO: 9611558

OFFICIAL

CONTACT:

Dr. JEN, KE-MIN NO 58, Fu-Chiun Street, Hsin-Chu City, 30067, TAIWAN TEL: 886-3-5208829 FAX:886-3-5209783 Email: ceirs.jen@msa.hinet.net

HIVOX Electric Stimulator TENS & EMS, HD2 TRADE NAME:

COMMON/USUAL Transcutaneous Nerve Stimulator & NAME: Electric Muscle Stimulator

Transcutaneous Nerve Stimulator CLASSIFICATION

NAME:

GZJ, Class II, 882.5890 REGULATION

NUMBER:

ID# Class II 800 59850

SECONDARY PRODUCT CODE: IPF, Class II, 890.5850

PREDICATED DEVICE:

MEDIHIGHTEC Medical Co., Ltd. TENS/EMS Combo, EMS, TENS K082514

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HIVOXImage: [logo]	HIVOX BIOTEK INC
	8/F, No.98 Shingde Road Sanchong City Taipei 241 Taiwan ROCPhone: +886 2 8511 2668 Fax: +886 2 8511 2669
Intended Use:	For TENS programs: The device is an electrical nerve stimulatorindicated for use for pain relief by applying an electrical current toelectrodes on a patient's skin to treat pain. In particular, this deviceis indicated for use for (1) Symptomatic relief of chronic (longterm) intractable pain, and (2) adjunctive treatment in themanagement of post-surgical and post-traumatic pain problems.For EMS programs: The device is an electrical powered musclestimulator indicated for medical purpose to repeatedly contractmuscles by passing electrical currents through electrodescontacting the affected body area. In particular, this device isindicated for use for (1) Relaxing muscle spasms, (2) Increasinglocal blood circulation, (3) Immediate post-surgical stimulation ofcalf muscles to prevent venous thrombosis, (4) Musclere-education, (5) Maintaining or increasing range of motion, and(6) Preventing or retarding disuse atrophy.
Description of Device:	The HIVOX Electric Stimulator TENS & EMS, HD2 generatessmall pulses of electrical current. Delivered along lead cables toelectrodes placed on your skin, these pulses pass through the skinand activated underlying nerves. The relief from chronic andacute pain that the HD2 can provide results from this electricalstimulation.
Performance TestsSubmitted:	The relevant standards including:1. IEC/EN 60601-1 : Medical electrical equipment Part 1.General requirements for safety, 1996.2. IEC/EN 60601-1-2 : Medical electrical equipment, Part 2.Electromagnetic compatibility - Requirements and tests, 2004.3. IEC/EN 60601-2-10 : Medical electrical equipment Part 2.Safetyof Nerve and Muscle Stimulators, 1987.
Non-Clinical TestsSubmitted:	The HIVOX Electric Stimulator TENS & EMS, HD2 has beentested in accordance with applicable standards for medical deviceelectrical safety, electromagnetic compatibility, and the particularrequirements for safety of nerve stimulators.Accessories also meet safety requirements: 510(k) electrodes arespecified, and the patient cable utilizes shrouded connectors tomeet lead wire safety requirements.System level testing including waveform testing was performed incombination the HIVOX Electric Stimulator TENS & EMS, HD2.
Clinical TestsSubmitted:	None
Conclusion:	As the product description and tests as above, the new device:HIVOX Electric Stimulator TENS & EMS, HD2 is as safe andeffective as, and the function in a manner equivalent to thepredicate device: MEDIHIGHTEC TENS/EMS Combo, EMS,TENS, K082514.

ﺗ

. .

devices in this aspect.

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HIVOXiff

HIVOX BIOTEK INC

8/F . No.98 Shingde Road Sanchong City Taipei 241 Taiwan ROC Fax: +886 2 8511 2669 Phone: +886 2 8511 2668

Comparison for Predicate Device & Subject Device

Comparison Areas	NEW DEVICE	PREDICATE DEVICE
510(k) number	K092448	K082514
Manufacturer	HIVOX Biotek Inc	Medihightec Medical Co. Ltd.
Device name	HD2TENS & EMS	MH8000/6000TENS/EMS Combo
Power source	DC 4.5V(AAA Battery x 3 )	One DC 9V battery
ChannelsSynchronousReciprocal	SAME	2YESYES
Computerized	SAME	No
Software provided	SAME	No
Constant current	No	YES
Constant voltage	YES	No
Max output voltage(Vp ±20%)	24.0V ±20% @ 500 Ω load	20.4V±20% @500 Ω load(40.8 Vp-p)
Max output current(mA ±20%)	48.0mA ±20% ( 500 Ω load )	40.8 mA±20% ( 500Ω load)(81.6 mA, p-p)
Pulse Width ( µs )	250 µs (fixed)	50~300 µs
Maximum Frequency	2~120.2 Hz (adjustable)	2~150 Hz (adjustable)
Max phase charge	□12.0 µC @ 500 ohms load	24.0 µC @ 500 ohm
Maximum CurrentDensity	0.59 mA/cm² @500Ω	1.06 mA/cm² @500Ω
Maximum PowerDensity	0.014 W/cm² @500Ω	2.4 m W/cm² @500Ω
Comparison Areas	NEW DEVICE	PREDICATE DEVICE
Channel isolation	SAME	YES
Line current isolation	SAME	N/A
Patient overridecontrol method	SAME	YES
Burst mode	SAME	YES
Housingmaterialand construction:	SAME	Plastic material
Standards:	SAME	IEC 60601-1:1988EN 60601-1-2:1990
Timer settingAutomatic shut off	SAME2 minutes	YES (05~90Min)30 Sec
Automatic overloadtrip current/voltagelevel	N/A	YES
Automatic no load trip	N/A	YES
Indicator displayUnit functioning:	Power ON	Power ON, Vpp
Low battery	Yes	NO
indicator:Voltage level:	NO	YES
Weight ( unit )	105 g w/o Battery	162 grams w/ battery
Dimensions ( unit )	120 x 52 x 17 mm	136 x 70 x 27 mm
Size of electrode	Carbon silicon of 45x45 mm	Irregular: 10x15cm

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K092448

Image /page/3/Picture/1 description: The image shows the word "HIVOX" in all caps, followed by a small superscript symbol and a stylized plus sign. The plus sign is made up of several small squares connected in a winding pattern. The text and symbol are all in black and are set against a white background.

HIVOX BIOTEK INC

8/F, No.98 Shingde Road Sanchong City Taipei 241 Taiwan ROC Phone: +886 2 8511 2668 Fax: +886 2 8511 2669

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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

Hivox Biotek Inc. c/o Dr. Ke-Min Jen 8F, No. 98, Shinde Rd., Sanchong City Taipei Hsien China (Taiwan) 24158

MAR 3 0 2010

Re: K092448

Trade/Device Name: Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: March 12, 2010 Received: March 19, 2010

Dear Dr. Jen:

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. Iisting 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

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Page 2 - Dr. Ke-Min Jen

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Kevin Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

K092448

Device Name:

HIVOX Electric Stimulator TENS & EMS, HD2

Indications for Use :

The TENS programs of HIVOX Electric Stimulator TENS & EMS, HD2:

The EMS programs of HIVOX Electric Stimulator TENS & EMS, HD2:

Prescription Use _ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

Page 1 of 1

510(k) Number K092448

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).