APPLICABLE FOR MH8000 (TENS/EMS COMBINATION UNIT) AND MH6000 (TENS/EMS COMBINATION UNIT) AND MH8200 (TENS) AND MH6200 (TENS): This 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 and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems.

APPLICABLE FOR MH8000 (TENS/EMS COMBINATION UNIT) AND MH6000 (TENS/EMS COMBINATION UNIT) AND MH8100 (EMS) AND MH6100 (EMS): This device is an electrically powered muscle stimulator indicated for use for medical purposes 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 MH8000 Series, which includes models MH8000, MH8100, MH8200, MH6000, MH6100, MH6200, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.

The three models MH8000, MH8100 and MH8200 have the same housing. The three models MH6000, MH6100 and MH6200 have the same housing.

The process to set the parameter and attach lead wires to the six models are also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings.

The MH8200 and MH6200 are the TENS device with 5 modes and adjustable pulse rate, pulse width and timer. The MH8100 and MH6100 are the EMS device with 3 modes and adjustable pulse rate, pulse width, on time, off time, ramp time and timer, The MH8000 and MH6000 are the combination unit with both TENS and EMS functions, The function can be selected by press buttons. The range of settings are identical to those of MH8200, MH8100, MH6100 and MH6200. The difference on the six units can be identified by the liquid crystal display.

AI/ML Overview

The provided text is a 510(k) summary for TENS/EMS devices. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new, unique device. Therefore, many of the requested categories related to medical imaging AI study design are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the way one would for a performance study of a diagnostic device. Instead, it demonstrates substantial equivalence by comparing the technological characteristics and output specifications of the new devices (MH8000 Series) to those of predicate devices (Comfy STIM, Comfy EMS, Comfy TENS). The "acceptance criteria" can be inferred as being substantially equivalent to the predicate device across various parameters, within acceptable deviations that do not raise new questions of safety or effectiveness.

Key Performance Metrics (Technological Characteristics & Output Specifications Comparison):

Feature/Parameter	Acceptance Criteria (Predicate Device K071951)	Reported Device Performance (New Devices MH8000 Series)	Meets Criteria? (Inferred)	Notes/Differences
Primary Safety Standards	EN60601-1, EN60601-1-2	Voluntary EN60601-1, EN60601-1-2	Yes	New device explicitly states "Voluntary" compliance but confirms meeting the same standards. Test report numbers provided (UT96026, UT96027, EM/2007/20045, EM/2007/20046).
Power Source	9 volt battery type 6F22	9 volt battery type 6F22	Yes	Identical.
Number of Output Modes	TENS/EMS Combo: 7; EMS: 3; TENS: 5	TENS/EMS Combo: 7; EMS: 3; TENS: 5	Yes	Identical.
Number of Output Channels	2	2	Yes	Identical.
Channel Isolation	By TRANSFORMER	By TRANSFORMER	Yes	Identical.
Waveform	Asymmetrical biphasic pulse	Asymmetrical biphasic pulse	Yes	Identical.
Shape	Rectangular	Rectangular	Yes	Identical.
Pulse Width Control Range	50µS and 300µS	50µS and 300µS	Yes	Identical.
Pulse Rate Control Range	2 Hz and 150 Hz	2 Hz and 150 Hz	Yes	Identical.
ON Time (EMS)	Adjustable, 2~90 seconds, 1 Sec./step	Adjustable, 2~90 seconds, 1 Sec./step	Yes	Identical.
OFF Time (EMS)	Adjustable, 2~90 seconds, 1 Sec./step	Adjustable, 2~90 seconds, 1 Sec./step	Yes	Identical.
Burst Mode (TENS)	Pulses per buster: 10; Burst per second: adjustable, 0.5~~5; Burst duration: 100 mSec.; Duty Cycle: adjustable 50~~500 mSec.	Pulses per buster: 9; Burst per second: 2; Burst duration: 100 mSec.; Duty Cycle: 200 mSec.	Yes	Difference noted, but determined not to pose new questions of safety/effectiveness. New device's burst rate is fixed at 2Hz (for TENS mode B) or fixed burst rate = 21Hz (for TENS mode B on page 8 table), while predicate is adjustable (0.5~~5 Hz). New device's duty cycle is fixed at 200msec, predicate is adjustable (50~~500 msec). Pulses per buster are 9 vs 10.
Max Output Voltage (+/- 20%)	TENS/EMS: 50V @ 500 Ohm; EMS: 50V @ 500 Ohm; TENS: 50V @ 500 Ohm	TENS/EMS: 40.8V @ 500 Ohm; EMS: 40.8V @ 500 Ohm; TENS: 40.8V @ 500 Ohm	Yes	Difference noted, new device is smaller than predicate (and also for 2000 & 10000 Ohm). Determined not to pose new questions of safety/effectiveness.
Max Output Current (+/- 20%)	TENS/EMS: 100mA @ 500 Ohm; EMS: 100mA @ 500 Ohm; TENS: 100mA @ 500 Ohm	TENS/EMS: 81.6mA @ 500 Ohm; EMS: 81.6mA @ 500 Ohm; TENS: 81.6mA @ 500 Ohm	Yes	Difference noted, new device is smaller than predicate (and also for 2000 & 10000 Ohm). Determined not to pose new questions of safety/effectiveness.
Max Phase Charge	30 micro-coulombs @ 500 Ohm	24 micro-coulombs @ 500 Ohm	Yes	Difference noted, new device is smaller than predicate. The document argues this is within the safe range (3 micro-coulombs minimum for effectiveness) and therefore acceptable.
Max Current Density	1.33mA/$cm^2$ @ 500 Ohm	1.06mA/$cm^2$ @ 500 Ohm	Yes	Difference noted, new device is smaller than predicate. Determined not to pose new questions of safety/effectiveness.
Max Power Density	3.7mW/$cm^2$ @ 500 Ohm	2.4mW/$cm^2$ @ 500 Ohm	Yes	Difference noted, new device is smaller than predicate. Determined not to pose new questions of safety/effectiveness. (This metric is not explicitly mentioned for the TENS-only device EV-804 but for EMS EV-805).
Patient Leakage Current	Not explicitly quantified in table for predicate, but predicate implied to meet standards.	Normal condition: 1.5uA; Single fault condition: 1.7uA	Yes	Explicit values for new device provided; implied compliance with safety standards for both. These values would need to be within accepted limits for medical devices.
Weight	150 grams (battery included)	162 grams (battery included)	Yes?	Difference noted, new device is slightly heavier. Determined not to pose new questions of safety/effectiveness.
Dimensions	10.1(L)x6.1(W)x2.45(H)(cm)	13.6(L)x7(W)x2.7(H)(cm)	Yes?	Difference noted, new device is larger. Determined not to pose new questions of safety/effectiveness.
Housing Materials	ABS, 94V-1, 80°C, UL Approved; PC board: FR4, 94V-1, 105°C, UL Approved	ABS, 94V-1, 80°C, UL Approved; PC board: FR4, 94V-1, 105°C, UL Approved	Yes	Identical.

The document concludes that "Above differences of Technological Characteristics do not pose any new questions of safety and effectiveness." and "According to above conclusions, the new devices are substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness."

Study Information (Not an AI-based Diagnostic Device Study)

The provided text is a 510(k) Pre-market Notification for a TENS/EMS device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical trial or AI performance study with the specific elements requested (sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance for AI, etc.).

Therefore, for the following points, the answer derived from the provided text is that the information is not applicable in the context of an AI-based diagnostic device study, or the study type is a non-clinical bench test comparison rather than a clinical performance study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. This is a non-clinical, bench testing comparison against specifications derived from a predicate device, not a human reader or AI performance study with a "test set" of cases/data points.
Data Provenance: Not applicable. The "data" consists of electrical output measurements and physical characteristics of the devices themselves, measured during manufacturing/testing processes, not patient data from a specific country or collected retrospectively/prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" for this type of device comparison is established by reference to engineering specifications, national/international standards (e.g., EN60601-1, EN60601-1-2), and the technical characteristics of the predicate device. No human experts are used to establish ground truth on patient outcomes or interpretations in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert interpretations found in AI studies. The determination of whether the new device meets specifications is based on direct measurement and comparison to predefined engineering and safety limits.

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

Not applicable. This device is an electrical stimulator, not an imaging device or an AI assistant for human readers. No MRMC study was conducted or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (TENS/EMS unit) which functions directly on a patient; it does not involve a "standalone algorithm" in the context of AI performance. Its function is its standalone performance in delivering electrical stimulation according to its parameters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The "ground truth" here is based on engineering specifications, compliance with recognized international safety and EMC standards (EN60601-1, EN60601-1-2), and the established output characteristics of the legally marketed predicate device (K071951). The intent is to show that the new device's physiological effects (pain relief, muscle stimulation) will be similar because its electrical output characteristics are substantially equivalent within safe parameters. References to textbooks for efficacy of TENS/EMS treatments are cited (Meryl Roth Gersh, Val Robertson, etc.), indicating that the principles of electrotherapy for the stated indications are well-established.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

In summary, the provided document describes a bench testing and specifications comparison study to demonstrate substantial equivalence for a TENS/EMS device, not an AI performance study as typically seen for diagnostic algorithms. The "acceptance criteria" were met by showing that the new device's technical characteristics and output parameters are either identical to or within acceptable safety and effectiveness limits compared to the predicate device, especially considering that any differences (like slightly lower maximum output) were determined not to raise new questions of safety or effectiveness.

Summary

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510(k) Summary As Required by 21 section 807.92 (c)

1. Submitter Name: MEDIHIGHTEC MEDICAL CO., LTD.

1. Address: 4F., No.180, Fu 1st St., Cidu District, Keelung City 20650, Taiwan R.O.C.
1. Phone: 886-2-2451-9988
1. Fax: 886-2-2451-1796
1. E-mail: sales(@medihightec.com
1. Contact Person: Mr. Mu-Sheng Hung
1. Date summary prepared: April 7th, 2008
1. Regulation Number: 882.5890; 890.5850
1. Product Code: GZJ; IPF

10. Device Trade or Proprietary Name:

(a) TENS/EMS Combo (Model MH8000)
(b)TENS/EMS Combo (Model MH6000)
(c) EMS (Model MH8100)
(d) EMS (Model MH6100)
(e) TENS (Model MH8200)
(f) TENS (Model MH6200)

11. Device Common or usual name:

(a) TENS/EMS COMBINATON UNIT (Model MH8000)
(b) TENS/EMS COMBINATON UNIT (Model MH6000)
(c) EMS UNIT (Model MH8100)
(d) EMS UNIT (Model MH6100)
(e) TENS UNIT (Model MH8200)
(f) TENS UNIT (Model MH6200)

12. Device Classification Name:

(a) Stimulator, nerve, transcutaneous, for pain relief (21 CFR 882.5890, Product Code GZJ).
(b) Stimulator, muscle, powered (21 CFR 890.5850, Product Code IPF).
(c) Combination of (i) Stimulator, nerve, transcutaneous, for pain relief AND (ii) Stimulator, muscle, powered (21 CFR 882.5890; 890.5850, Product Code GZJ; IPF)

13. Substantial Equivalency is claimed against the following device:

(a) The new device MH8000 and MH6000 compared to the predicate devices: Comfy STIM, model EV-806 from Everyway Medical instruments Co., Ltd. 510k# K071951, Product Code: GZJ; IPF.
(b) The new device MH8100 and MH6100 compared to the predicate devices: Comfy EMS, model EV-805 from Everyway Medical instruments Co., Ltd. 510k# K071951, Product Code: IPF.

OCT 2 1 2008

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(c) The new device MH8200 and MH6200 compared to the predicate devices: Comfy TENS, model EV-804 from Everyway Medical instruments Co., Ltd. 510k# K071951, Product Code: GZJ.

14. Description of the Device:

The three models MH8000, MH8100 and MH8200 have the same housing. The three models MH6000, MH6100 and MH6200 have the same housing.

The process to set the parameter and attach lead wires to the six models are also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings.

		New Device	Predicate Device
1.	510(k) Number	To be Assigned	K071951
2.	Device Name, Model	MH8000/MH6000ComboMH8100/MH6100 EMSMH8200/MH6200 TENS	TENS/EMS EV-806 TENS/EMS, ComfyStimEV-805 EMS, Comfy EMSEV-804 TENS, Comfy TENS
3.	Manufacturer	MEDIHIGHTEC MEDICALLTD.	CO., Everyway MedicalInstruments Ltd.
4.	Power Source(s)	9 volt battery type 6F22	9 volt battery type 6F22
	- Method of Line Current Isolation	N/A	N/A
	- Patient Leakage Current
	-Normal condition	1.5uA
	-Single fault condition	1.7uA
5.	Number of Output Modes	7	7
6.	Number of Output Channels	2	2
	- Synchronous or Alternating?	Synchronous and Alternating	Synchronous and Alternating
	- Method of Channel Isolation	By TRANSFORMER	By TRANSFORMER
7.	Regulated Current or RegulatedVoltage?	5V	5V
8.	Software/Firmware/MicroprocessorControl?	Yes	Yes
9.	Automatic Overload Trip?	No	No
10.	Automatic No-Load Trip?	No	No

Technological Characteristics, New device vs. Predicate device

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	11. Automatic Shut Off?	No	No
	12. Patient Override Control?	No	No
	13. Indicator Display:
	- On/Off Status?	Yes	Yes
	- Low Battery?	Yes	Yes
	- Voltage/Current Level?	Yes	Yes
	14. Timer Range (minutes)	Yes	Yes
	15 Pulse Width	The range of Pulse Width control is between 50µS and 300µS.	The range of Pulse Width control is between 50µS and 300µS.
	16 Frequency	The range of Pulse Rate control between 2 Hz and 150 Hz.	The range of Pulse Rate control between 2 Hz and 150 Hz.
	17 Phase Duration	Pulse Width control is between 50µS and 300µS.	Pulse Width control is between 50µS and 300µS.
	18 ON Time	Adjustable, 2~90 seconds, 1 Sec./ step	Adjustable, 2~90 seconds, 1 Sec./ step
	19 OFF Time	Adjustable, 2~90 seconds, 1 Sec./ step	Adjustable, 2~90 seconds, 1 Sec./ step
	20 Burst Mode	a. Pulses per buster: 9b. Burst per second: 2c. Burst duration: 100 mSec.d. Duty Cycle: 200 mSec.	a. Pulses per buster: 10b. Burst per second adjustable, 0.5~~5c. Burst duration: 100 mSec.d. Duty Cycle: adjustable 50~~500 mSec.
21	Compliance with Standards?	Voluntary EN60601-1, EN60601-1-2	EN60601-1, EN60601-1-2
	22 Compliance with 21 CFR 898?	Yes	Yes
	23 Weight	162 grams (battery included)	150 grams (battery included)
	24 Dimensions	13.6(L)x7(W)x2.7(H)(cm)	10.1(L)x6.1(W)x2.45(H)(cm)
	25 Housing Materials and Construction	1. Enclosure: ABS, 94V-1, 80°C, UL Approved.2. PC board: FR4, 94V-1, 105°C, UL Approved.	1. Enclosure: ABS, 94V-1, 80°C, UL Approved.2. PC board: FR4, 94V-1, 105, UL Approved.

Above differences of Technological Characteristics do not pose any new questions of safety and effectiveness.

15. Intended use of the device:

The intended Use of TENS, Model MH8200 and MH6200 TENS is as follows: This device is an electrical nerve stimulator intended 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 intended for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems

The intended Use of EMS, Model MH8100 and MH6100 EMS is as follows:

The device is an electrically powered muscle stimulator intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular this device is intended for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation,

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(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.

The Intended Use of TENS/EMS COMBO, Model MH8000 and MH6000 TENS/EMS Combination Unit are as follows:

This combination device is intended 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 intended for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems. It is also intended for use medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is intended 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.

16. Non-Clinical Testing:

Non-Clinical Testing Result: New device MH8000/MH6000 vs. Predicate device EV-806

		New Device	Predicate Device
1.	510(k) Number	To be Assigned	K071951
2.	Device Name, Model	MH8000/MH6000Combo	TENS/EMS EV-806 TENS/EMS, ComfyStim
3.	Manufacturer	MEDIHIGHTEC MEDICAL CO.,LTD.	Everyway MedicalInstruments Ltd.
4.	Power Source(s)	9 volt battery type 6F22	9 volt battery type 6F22
5.	Number of Output Modes	7	7
6.	Number of Output Channels	2	2
	- Synchronous or Alternating?	Synchronous and Alternating	Synchronous and Alternating
	- Method of Channel Isolation	By TRANSFORMER	By TRANSFORMER
7.	Waveform	Asymmetrical biphasic pulse	Asymmetrical biphasic pulse
8.	Shape	Rectangular	Rectangular
9.	Maximum Output Voltage (+/- 20%)	40.8V @ 500 Ohm77.6V @ 2000 Ohm102V @ 10000 Ohm	50V @ 500 Ohm150V @ 2000 Ohm194V @ 10000 Ohm
10.	Maximum Output Current (+/- 20%)	81.6mA @ 500 Ohm38.8mA @ 2000 Ohm10.2mA @ 10000 Ohm	100mA @ 500 Ohm75mA @ 2000 Ohm19.4mA @ 10000 Ohm
11.	Pulse Width	The range of Pulse Width control isbetween 50 $ μ $ S and 300 $ μ $ S.	The range of Pulse Widthcontrol is between 50 $μ$ S and300 $μ$ S.
12.	Frequency	The range of Pulse Rate controlbetween 2 Hz and 150 Hz.	The range of Pulse Ratecontrol between 2 Hz and 150Hz.
13.	Maximum Phase Charge	24 micro-coulombs @ 500 Ohm	30 micro-coulombs @ 500Ohm
14.	Maximum Current Density	1.06mA/ $cm2$ @ 500 Ohm	1.33mA/ $cm2$ @ 500 Ohm
		New Device	Predicate Device
1.	510(k) Number	To be Assigned	K071951
2.	Device Name, Model	MH8100/MH6100 EMS	EV-805 EMS, Comfy EMS
3.	Manufacturer	MEDIHIGHTEC MEDICALLTD.	Everyway MedicalInstruments Ltd.
4.	Power Source(s)	9 volt battery type 6F22	9 volt battery type 6F22
5.	Number of Output Modes	3	3
6.	Number of Output Channels	2	2
	- Synchronous or Alternating?	Synchronous and Alternating	Synchronous and Alternating
	- Method of Channel Isolation	By TRANSFORMER	By TRANSFORMER
7.	Waveform	Asymmetrical biphasic pulse	Asymmetrical biphasic pulse
8.	Shape	Rectangular	Rectangular
9.	Maximum Output Voltage (+/- 20%)	40.8V @ 500 Ohm77.6V @ 2000 Ohm102V @ 10000 Ohm	50V @ 500 Ohm150V @ 2000 Ohm194V @ 10000 Ohm
10.	Maximum Output Current (+/- 20%)	81.6mA @ 500 Ohm38.8mA @ 2000 Ohm10.2mA @ 10000 Ohm	100mA @ 500 Ohm75mA @ 2000 Ohm19.4mA @ 10000 Ohm
11.	Pulse Width	The range of Pulse Width control isbetween 50µS and 300µS.	The range of Pulse Width controlis between 50µS and 300µS.
12.	Frequency	The range of Pulse Rate controlbetween 2 Hz and 150 Hz.	The range of Pulse Ratecontrol between 2 Hz and 150 Hz.
13.	Maximum Phase Charge	24 micro-coulombs @ 500 Ohm	30 micro-coulombs @ 500 Ohm
14.	Maximum Current Density	$1.06mA_{rms}/cm^2$ @ 500 Ohm	$1.33mA_{rms}/cm^2$ @ 500 Ohm
15.	Maximum Power Density	$2.4mW_{rms}/cm^2$ @ 500 Ohm	$3.7mW_{rms}/cm^2$ @ 500 Ohm
16.	Burst Mode	a. Pulses per buster: 9b. Burst per second: 2c. Burst duration: 100 mSec.d. Duty Cycle: 200 mSec.	a. Pulses per buster: 10b. Burst per second:adjustable, 0.5~~5c. Burst duration: 100 mSec.d. Duty Cycle: adjustable,50~~500 mSec.
17.	ON Time	Adjustable, 2~90 seconds, 1 Sec./ step	Adjustable, 2~90 seconds, 1 Sec./ step
18.	OFF Time	Adjustable, 2~90 seconds, 1 Sec./ step	Adjustable, 2~90 seconds, 1 Sec./ step
	New Device	Predicate Device
1. 510(k) Number	To be Assigned	K071951
2. Device Name, Model	MH8200/MH6200 Combo	TENS/EMS/EV-804 TENS, Comfy TENS
3. Manufacturer	MEDIHIGHTEC MEDICAL LTD.	Everyway Medical Instruments Ltd.
4. Power Source(s)	9 volt battery type 6F22	9 volt battery type 6F22
5. Number of Output Modes	5	5
6. Number of Output Channels- Synchronous or Alternating?- Method of Channel Isolation	2Synchronous and AlternatingBy TRANSFORMER	2Synchronous and AlternatingBy TRANSFORMER
7. Waveform	Asymmetrical biphasic pulse	Asymmetrical biphasic pulse
8. Shape	Rectangular	Rectangular
9. Maximum Output Voltage (+/- 20%)	40.8V @ 500 Ohm77.6V @ 2000 Ohm102V @ 10000 Ohm	50V @ 500 Ohm150V @ 2000 Ohm194V @ 10000 Ohm
10. Maximum Output Current (+/- 20%)	81.6mA @ 500 Ohm38.8mA @ 2000 Ohm10.2mA @ 10000 Ohm	100mA @ 500 Ohm75mA @ 2000 Ohm19.4mA @ 10000 Ohm
11. Pulse Width	The range of Pulse Width control is between 50µS and 300µS.	The range of Pulse Width control is between 50µS and 300µS.
12. Frequency	The range of Pulse Rate control between 2 Hz and 150 Hz.	The range of Pulse Rate control between 2 Hz and 150 Hz.
13. Maximum Phase Charge	24 micro-coulombs @ 500 Ohm	30 micro-coulombs @ 500 Ohm
14. Maximum Current Density	$1.06mA_{rms}/cm^2$ @ 500 Ohm	$1.33mA_{rms}/cm^2$ @ 500 Ohm
15. Maximum Power Density	$2.4mW_{rms}/cm^2$ @ 500 Ohm	$3.7mW_{rms}/cm^2$ @ 500 Ohm
16. Burst Mode	a. Pulses per buster: 9b. Burst per second: 2c. Burst duration: 100 mSec.d. Duty Cycle: 200 mSec.	a. Pulses per buster: 10b. Burst per second adjustable, 0.5~~5c. Burst duration: 100 mSec.d. Duty Cycle: adjustable 50~~500 mSec.

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Non-Clinical Testing Result: New device MH8200/MH6200 vs. Predicate device EV-804

According to above results of manufacture testing demonstrate that the output characteristics of the new devices are substantially equivalent to those of the three predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness.

17. Safety and Effectiveness of the device:

This new series is safe and effective as the predicate devices cited above.

(1) The new series device comply with safety standard EN60601-1:1990, Including Amendment A1 (1993) and A2 (1995), A13 (1996), IEC60601-1:1988, Including Amendment A1 (1991) and A2 (1995). Test report number is UT96026 and UT96027, See Chapter 11, C.1.

(2) The new series device comply with EMC compliance standard EN60601-1-2:2001 CISPR 11:1997+A1:1999+A2:2002 Group 1:Class B,

IEC61000-4-2:1995+A1:1998+A2:2000, IEC61000-4-3:2002,

IEC61000-4-8:1993+A1:2000. Test report number is EM/2007/20045 and EM/2007/20046, See Chapter 11, C.2.

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(3) Regarding leakage current, please refer to safety report UT96026 and UT96027, Page 15, Clause 19 and appended table 19.4g. 19.4h and 19.4.h3. See Chapter 11, C.1.

18. Conclusions:

Our MH6000/MH8000 TENS and EMS Combo unit integrates EMS and TENS functions with 7 stimulation modes.

S Mode (Synchronous) and A Mode (Alternative) designed for EMS,

N Mode (Normal), M Mode (Rate and Width Modulation), B Mode (Burst), SD Mode

(Width Modulation) and MR Mode (Rate Modulation) designed for TENS.

Press MODE button to select only one stimulation mode, therefore TENS and EMS are used independently for the combination devices.

New devices and Predicate devices are the same in the:

1. Power Source:
1. Number of Output Modes;
1. Number of Output Channels;
1. With Microprocessor Control;
1. Standards;
1. Pulse Width control;
1. Pulse Rate control;
1. ON tome, OFF time, Ramp time; and
1. Waveform Shape.

The difference of new devices and Predicate devices is as follows:

1. Patient Leakage Current;
1. Weight:
1. Dimensions;
1. The Maximum Output Voltage of the new devices is smaller than the Predicate devices;
1. The Maximum Output Current of the new devices is smaller than the Predicate devices;
1. The Maximum Phase Charge of the new devices is smaller than the Predicate devices;

The Maximum Current Density of the new devices is smaller than the Predicate devices; and
The Maximum Power Density of the new devices is smaller than the Predicate devices.

The maximum output Charge of the new devices is smaller than the predicate devices, so the maximum output Charge will not exceed the safe range.

The minimum phase charge for effectiveness of Transcutaneous Neural Stimulation is 3 micro-coulombs. Please refer to: M. Linzer, and D.M. Long, "Transcutaneous Neural Stimulation for Relief of Pain," IEEE Transactions on Biomedical Engineering, Vol.

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References:

The EMS designed 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.

The References and studies are as follows:

Meryl Roth Gersh, M.M.Sc., P.T., Electrothcrapy in Rehabilitation, F.A. Davis Company, 1992
Val Robertson, Alex Ward, John Low and Ann Reed, Electrotherapy Explained Principles and Practice, Fourth Edition, Elsevier Ltd, 2006
Joseph Kahn, PhD, PT, Principle and Practice of Electrotherapy, Fourth Edition, Elsevier (Singapore) Pte Ltd, 2004
Sheila Kitchen MSc PhD DipPT MCSP, Electrotherapy Evidence-Based Practice, Eleventh Edition, Elsevier (Singapore) Pte Ltd, 2004
Michelle H. Cameron, M.D., P.T., O.C.S., Jennifer A. Rohl, B.S. , Physical Agents in Rehabilitation, Elsevier Ltd, 2006

		New Device		Predicate Device
1.	510(k) Number	To be Assigned		K071951
2.	Device Name, Model	MH8000 TENS/EMS ComboMH8100 EMSMH8200 TENSMH6000 TENS/EMS ComboMH6100 EMSMH6200 TENS		EV-806 TENS/EMS, Comfy StimEV-805 EMS, Comfy EMSEV-804 TENS, Comfy TENS
3.	Manufacturer	MEDIHIGHTEC MEDICAL CO., LTD.		Everyway Medical Instruments Ltd.
4.	Pulse Width	The range of Pulse Width control is between 50uS and 300uS.		The range of Pulse Width control is between 50uS and 300uS.
5	Frequency	The range of Pulse Rate control between 2 Hz and 150 Hz.		The range of Pulse Rate control between 2 Hz and 150 Hz.
6	Stimulation Modes
	For EMS	S Mode(Synchronous)	Stimulation of both channels will occur simultaneously	S Mode(Synchronous)	Stimulation of both channels will occur simultaneously
		A Mode(Alternative)	Stimulation of Channel 1 and Channel 2 will occur alternately.	A Mode(Alternative)	Stimulation of Channel 1 and Channel 2 will occur alternately.
	For TENS	N Mode(Normal)	Continuous output, pulse rate and pulse width are adjustable.	N Mode(Normal)	Continuous output, pulse rate and pulse width are adjustable.
		M Mode(Rate and Width Modulation):	Per cycle time is 1 second. Each cycle contains two phases. During the first 0.5 sec. phase, the Pulse Width runs at 50% of its width setting and Pulse Rate runs at its rate setting, then during the second 0.5 sec. phase, the Pulse Rate runs at 50% of its rate setting and Pulse width runs at its width setting. The cycle is then repeated.	M Mode(Rate and Width Modulation):	Per cycle time is 1 second. Each cycle contains two phases. During the first 0.5 sec. phase, the Pulse Width runs at 50% of its width setting and Pulse Rate runs at its rate setting, then during the second 0.5 sec. phase, the Pulse Rate runs at 50% of its rate setting and Pulse width runs at its width setting. The cycle is then repeated.
		B Mode(Burst)	Burst rate fixed =21HzPulse width adjustable, 50~260uSFrequency fixed = 100 Hz	B Mode(Burst)	Burst rate adjustable, 0.5~~5 HzPulse width adjustable, 50~~260uSFrequency fixed = 100 Hz.
		SD Mode(Width Modulation):	Pulse Width is modulated over a period of 3 seconds from its original setting value down to 60% of its setting, then modulated over another 3 seconds period at its original value. The cycle is then repeated. Per cycle time is 6 seconds.	SD1 Mode(Width Modulation):	Pulse Width is modulated over a period of 3 seconds from its original setting value down to 60% of its setting, then modulated over another 3 seconds period at its original value. The cycle is then repeated. Per cycle time is 6 seconds.

The Output Specifications. New devices vs. Predicate devices

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		MR Mode(RateModulation)	SD2 Mode(RateModulation)
7	MaximumOutput Voltage(+/- 20%)	40V @ 500 Ohm	50V @ 500 Ohm
8	MinimumOutput Voltage(+/- 20%)	0.5V @ 500 Ohm	0.5V @ 500 Ohm
9	MaximumOutput Current(+/- 20%)	80mA @ 500 Ohm	100mA @ 500 Ohm
	10 MinimumOutput Current(+/- 20%)	1mA @ 500 Ohm	1mA @ 500 Ohm
	11 MaximumPhase Charge	$40V \div 500ohm \times 300uSec$ =24 micro-coulombs @500 Ohm	$50V \div 500ohm \times 300uSec$ =30 micro-coulombs @ 500 Ohm
	12 MinimumPhase Charge	$0.5V \div 500ohm \times 50uSec$ =0.05 micro-coulombs @500 Ohm	$0.5V \div 500ohm \times 50uSec$ =0.05micro-coulombs @ 500 Ohm

The Phase Charge (micro-coulombs) =Amplitude (V) = Load (ohm) × Pulse Duration (uS). The amplitude is the size of the stimulus applied. It is measured either as the stimulus voltage or current. Stimulus voltages used clinically are typically in the range 10V to 100V or more. Stimulus currents are typically in the range 10mA to 100mA for clinical treatments. The amplitude is usually set according to the patient's level of comfort and to the aims of a treatment (refer to References 2., 3. and 4.). Recommended parameters for electrical stimulation to produce muscle contractions: Pulse duration 150 to 200uS for small muscles, 200 to 350uS for large muscles. Frequency 35 to 80Hz, Amplitude is "to contraction" (refer to References 5.). Stimulus parameters used for treatment: Pulse duration 200 to 300uS. Frequency 24 to 80Hz, Amplitude is 30 to 80mA (refer to References 1.).

According to the References, the amplitude is usually set according to the patient's level of comfort and to the aims of a treatment, therefore the effectiveness of EMS is decided by frequency and Pulse duration. The new devices have the same frequency and Pulse duration with the predicate devices (see the Output Specifications): and. The phase charge of the new devices is adjustable between 0.05 to 24 micro-coulombs enough demand, therefore the new devices and predicate devices have the same effectiveness.

According to above conclusions, the new devices are substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness.

3-9

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/9/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medihightec Medical Company Limited % Underwriters Laboratories, Inc. Mr. Jeffrey D. Rongero 12 Laboratory Drive Research Triangle, North Carolina 27709

OCT 21 2008

Re: K082514

Trade/Device Name: MH8000 TENS/EMS Combo, MH6000 TENS/EMS Combo, MH8100 EMS, MH6100 EMS, MH8200 TENS, MH6200 TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: October 2, 2008 Received: October 6, 2008

Dear Mr. Rongero:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Jeffrey D. Rongero

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known):

Device Name:

The MH8000 TENS/EMS Combo, MH6000 TENS/EMS Combo, MH8100 EMS, MH6100 EMS, MH8200 TENS, MH6200 TENS. They are Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS).

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliman

Division of Gener and Neurological Dev

510(k) Number

Page 1 of 1

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).