Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

• K Number: K171978
• Device Name: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
• Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.
• Date Cleared: 2017-10-02 ( 94 days)
• Product Code: IPF , GZJ , LIH
• Regulation Number: 890.5850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: K093138 , K141076 , K071137
• Predicate For: K213197 , K231440

Intended Use

Combo Stimulator MT9000
For TENS/IF/MIC mode

1. Symptomatic relief of chronic intractable pain
2. Post traumatic pain
3. Post surgical pain
   For EMS mode
4. Relaxation of muscle spasm.
5. Increase of local blood flow circulation
6. Prevention or retardation of disuse atrophy
7. Muscle re-education
8. Maintaining or increasing range of motion.
9. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Combo Stimulator LT7102
For TENS/IF/MIC mode

1. Symptomatic relief of chronic intractable pain
2. Post traumatic pain
3. Post surgical pain
   For EMS/RUSS mode
4. Relaxation of muscle spasm.
5. Increase of local blood flow circulation
6. Prevention or retardation of disuse atrophy
7. Muscle re-education
8. Maintaining or increasing range of motion.
9. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

TENS Stimulator Intensity 10

1. Symptomatic relief of chronic intractable pain
2. Post traumatic pain
3. Post surgical pain

Device Description

MT9000, LT7102 and Intensity 10 are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator sends gentle electrical current to underlying nerves and muscle group via electrode 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 3 models MT9000, LT7102 and Intensity 10 have similar housing with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user.

AI/ML Overview

The provided document is a 510(k) Summary for medical devices (stimulators) and does not contain information about acceptance criteria or a study proving device performance against such criteria for AI/ML-driven diagnostic devices.

The document details the substantial equivalence of new stimulator models (Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10) to previously marketed predicate devices. The "performance data" section covers biocompatibility, electrical safety, EMC, and software verification/validation, which are typical for this type of medical device submission, but do not involve acceptance criteria or studies related to AI/ML diagnostic performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and reported device performance (for AI/ML diagnostic context)
2. Sample size for the test set and data provenance
3. Number of experts and qualifications for ground truth establishment
4. Adjudication method
5. MRMC comparative effectiveness study details (effect size)
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. Ground truth establishment for the training set

The document is primarily focused on demonstrating that the new devices have the "same intended use and technological characteristics" as existing devices, and that changes do not affect safety or effectiveness, as confirmed by regulatory compliance testing (e.g., IEC standards).

Summary

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October 2, 2017

Shenzhen Dongdixin Technology Co., Ltd. Siping Yuan R.A. Specialist No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen, 518108 CN

Re: K171978

Trade/Device Name: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, LIH Dated: June 15, 2017 Received: July 5, 2017

Dear Siping Yuan:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Vivek J. Pinto -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

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Indications for Use

510(k) Number (if known) K171978

Device Name

Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

Indications for Use (Describe)

Combo Stimulator MT9000

For TENS/IF/MIC mode

• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain
• For EMS mode
• Relaxation of muscle spasm. 1.
• 2. Increase of local blood flow circulation
• 3. Prevention or retardation of disuse atrophy
• 4. Muscle re-education
• న. Maintaining or increasing range of motion.
• Immediate post-surgical stimulation of muscles to prevent venous thrombosis 6.

Combo Stimulator LT7102

For TENS/IF/MIC mode

• Symptomatic relief of chronic intractable pain 1.
• 2. Post traumatic pain
• 3. Post surgical pain

For EMS/RUSS mode

• Relaxation of muscle spasm. 1.
• 2. Increase of local blood flow circulation
• 3. Prevention or retardation of disuse atrophy
• Muscle re-education 4.
• న. Maintaining or increasing range of motion.
• 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

TENS Stimulator InTENSity 10

• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for the X in DIXIN, which is in yellow. There are also three Chinese characters to the right of the English text.

001_510 (k) Summary Version: 1.1

510(k) SUMMARY

as required by section 21 CFR 807.92

Date of Submission:	06/15/2017
Submitter's Name:	Shenzhen Dongdixin Technology Co., Ltd
Address:	No. 3 Building, Xilibaimang Xusheng IndustrialEstate Nanshan, Shenzhen, CHINA 518108
E-mail:	[e-mail]
Tel:	[phone]
FAX:	[phone]
Contact:	Siping Yuan

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DO TECHNOLOGY CO., L

001_510 (k) Summary Version: 1.1

• 1. Proposed Device:

Trade Name:	Combo Stimulator MT9000Combo Stimulator LT7102TENS Stimulator Intensity 10
Classification Name:	Stimulator, Muscle, Powered
Regulation Number:	890.5850
Product Code:	IPF
Device Class:	II
Trade Name:	Combo Stimulator MT9000Combo Stimulator LT7102
Classification Name:	Stimulator, Nerve, Transcutaneous. For pain relie-
Regulation Number:	882.5890
Product Code:	GZJ
Device Class:	II

Trade Name:	Combo Stimulator MT9000Combo Stimulator LT7102
Classification Name:	Interferential current therapy
Regulation Number:	Unclassified
Product Code:	LIH
Device Class:	II

2. Predicate Device:

Legally Marketed Device:	MT9000 Series Electro-Stimulator
510(k) Number:	K093138
Manufacturer:	Shenzhen Dondixin Technology Co., Ltd.
Legally Marketed Device:	Sonicator® Plus 940, ME940
510(k) Number:	K071137
Manufacturer:	Mettler Electronics Corp.

3. Description of Proposed Device:

MT9000, LT7102 and Intensity 10 are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator sends gentle electrical current to underlying nerves and muscle group via electrode applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according

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Image /page/6/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for a diagonal line in the middle of the word "DONGDIXIN", which is in orange. To the right of the company name are three Chinese characters in blue. The words "TECHNOLOGY CO., LTD." are in a smaller font size and are located below the company name.

to the needs of patients.

The 3 models MT9000, LT7102 and Intensity 10 have similar housing with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user.

4. Description of All Device Modification(s)

The Combo Stimulator MT9000 only changes the energy type and added the adapter power supply. Compared with the existing device (MT9000), they have the same control mechanism, IFU, operating principle, performance specification, dimensional specifications, materials and software. The new change part have been evaluated and passed the requirement based on IEC60601-1-2 and IEC60601-2-10.

The Combo Stimulator LT7102 change the 9-volt battery to the recharge Lithium battery, add the electrode accessories like as different part electrode belt and make it more convenient for the user. Meanwhile, we added the RUSSIAN electrical stimulation mode that together with the TENS, IF and MICROCURRENT. Compared with the existing device (MT9000), they have the same control mechanism, IFU, operating principle, materials and performance specification. And this modification does not affect the intended use of the device or alter the fundamental scientific technology of the device. The new change part have been evaluated and passed the requirement based on IEC60601-1, IEC60601-1-2 and IEC60601-2-10.

Compared with the existing device (MT9001), The TENS Stimulator Intensity 10 only has TENS mode and the following parts have changed:

• Changes the energy type and added the adapter power supply. 1)
• 2. Change the dimensional specification.
• Change the LCD UI and make it more convenient for the user. 3)

And these changes have been evaluated and passed the requirement based on IEC60601-1, IEC60601-1-2 and IEC60601-2-10.

5. Proposed Device Intended for Use Statement:

Device Name: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator Intensity 10

Indications for Use:

Combo Stimulator MT9000

For TENS/IF/MIC mode

• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain

For EMS mode

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DON TECHNOLOGY CO., L

001 510 (k) Summary Version: 1.1

• 1. Relaxation of muscle spasm.
• 2. Increase of local blood flow circulation
• 3. Prevention or retardation of disuse atrophy
• 4. Muscle re-education
• 5. Maintaining or increasing range of motion.
• 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Combo Stimulator LT7102

For TENS/IF/MIC mode

• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain
• For EMS/RUSS mode
• 1. Relaxation of muscle spasm.
• 2. Increase of local blood flow circulation
• 3. Prevention or retardation of disuse atrophy
• 4. Muscle re-education
• 5. Maintaining or increasing range of motion.
• 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

TENS Stimulator Intensity 10

• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain

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Image /page/8/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and orange. The text "DONGDIXIN" is in large, bold, blue letters, with an orange "X". Below that, the text "TECHNOLOGY CO., LTD." is in smaller, blue letters.

6. Technological Characteristics and Substantial Equivalence

		New device	New device	New device	Predicate device	Predicate device	Discussion
1	510K#	To be assigned	To be assigned	To be assigned	K093138	K071137	N/A
2	Device Name	Combo StimulatorLT7102	ComboStimulatorMT9000	TENS StimulatorIntensity 10	MT9000 ComboTENS/EMS/IF/MICStimulator	Sonicator Plus940	N/A
3	Manufacturer	Shenzhen Dongdixin Technology Co., Ltd.				Mettler Electronics	N/A
4	Intended for use	Combo Stimulator MT9000For TENS/IF/MIC mode1. Symptomatic relief of chronic intractable pain2. Post traumatic pain3. Post surgical painFor EMS mode1. Relaxation of muscle spasm.2. Increase of local blood flow circulation3. Prevention or retardation of disuse atrophy4. Muscle re-education5. Maintaining or increasing range of motion.6. Immediate post-surgical stimulation of calf muscles toprevent venous thrombosis			For TENS/IF/MICmode1. Symptomaticrelief of chronicintractable pain2. Posttraumatic pain3. post surgicalpainFor EMS mode1. Relaxation ofmuscle spasm.2. Increase oflocal blood flowcirculation3. Preventionor retardation ofdisuse atrophy4. Musclere-education5. Maintainingor increasingrange of motion	4-Pole Interferential,2-Pole Interferential,TENS andMicrocurrentwaveforms1. Symptomatic reliefof chronic intractablepain2. Post-traumaticpain3. Post-surgical painEMS, TENS, Hi Voltand RussianwaveformsI. Relaxation ofmuscle spasms2. Increase localblood circulation3. Prevention orretardation of disuseatrophy4. Musclere-education	Same
		Combo Stimulator LT7102For TENS/IF/MIC mode1. Symptomatic relief of chronic intractable pain2. Post traumatic pain3. Post surgical pain
		For EMS/RUSS mode1. Relaxation of muscle spasm.2. Increase of local blood flow circulation3. Prevention or retardation of disuse atrophy4. Muscle re-education5. Maintaining or increasing range of motion.6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis			6. Immediatepost-surgicalstimulation ofmuscles toprevent venousthrombosis	5. Maintaining orincreasing range ofmotion6. Immediate postsurgical stimulationof calf muscles toprevent venousthrombosis
		TENS Stimulator Intensity 101. Symptomatic relief of chronic intractable pain2. Post traumatic pain3. Post surgical pain
5	Power Source	3.7V Li-ion BatteryCharger output: 5.0VDC, 300mA	9V BatteryAdapter Output: 9VDC 0.8A	9V BatteryAdapter Output: 9VDC 0.8A	9V Battery	AC Line	Different, but they allcomply with IEC 60601-1requirements.
	Method of Line currentisolation	N/A	N/A	N/A	Battery Supply N/A	Reinforced insulation
	- Patient LeakageCurrent-Normal condition	5 uA	4 uA	1 uA	0.61uA	>50uA
	-Single fault condition	5 uA	4 uA	9 uA	0.68uA	>50uA
6	Number of OutputModes	5	4	1	MT9000 4MT9001 1MT9002 1MT9003 1MT9004 1	8	Different, the number ofoutput mode is the featureof device, doesn't affect thesafety and effectiveness
7	Number of OutputChannels	2	2	2	2	4	Different, the number ofoutput channels is thefeature of device, doesn't
	- Synchronous orAlternating?	Synchronous andAlternating	Synchronous andAlternating	Synchronous	Synchronous andAlternating	Synchronous andAlternating	affect the safety andeffectiveness
	- Method of ChannelIsolation?	By enclosure	By enclosure	By enclosure	By enclosure	By transformer	Different, but they allcomply with IEC 60601-1requirements.
8	Constant Current?Constant Voltage?	YesNo	YesNo	YesNo	YesNo	YesNo	Same
9	Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	Yes	Yes	Same
10	Automatic OverloadTrip?Automatic Over CurrentTrip?	YesYes	YesYes	YesYes	YesYes	YesYes	Same
11	Automatic No LoadTrip?	Yes	Yes	Yes	Yes	Yes	Same
12	Automatic Shut off?	Yes	Yes	Yes	Yes	Yes	Same
13	Patient OverrideControl?	No	No	No	No	No	Same
14	Indicator Display-On/Off Status?-Voltage/Current Level?-Low Battery?	YesYesYes	YesYesYes	YesYesYes	YesYesYes	YesYesN/A	SameSameSame
15	WaveformTENSEMSInterferentialMicrocurrentRussian	BiphasicBiphasicBiphasicMonophasicBiphasic	BiphasicBiphasicN/AN/AN/A	BiphasicBiphasicN/AN/AN/A	BiphasicBiphasicBiphasicMonophasicN/A	BiphasicBiphasicBiphasicMonophasic orBiphasic	Similar

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Image /page/9/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for a yellow line that crosses the "X" in "DIXIN". There are also three Chinese characters to the right of the English text.

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Image /page/10/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue and yellow. The text "DONGDIXIN" is in large, bold, blue letters, and the text "TECHNOLOGY CO., LTD." is in smaller, blue letters below it. To the right of the English text is the company name in Chinese.

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Image /page/11/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue and yellow. The text "DONGDIXIN" is in large, bold, blue letters, and the text "TECHNOLOGY CO., LTD." is in smaller, blue letters below it. To the right of the English text is the company name in Chinese.

16	Shape					Biphasic
	TENS	Square	Square	Square	Square	Square	Same with unmodifieddevice MT9000, different
	EMS	Square	Square	N/A	Square	Sinusidal	from Sonicator Plus940.
	Interferential	Square	Square	N/A	Square	Sinusidal	The shape is the feature
	Microcurrent	Square	Square	N/A	Square	Square	of device, doesn't affect
	Russian	Square	N/A	N/A	N/A	Gated Sinusoidal	the safety andeffectiveness
17	Max Output Voltage (V) ±20%
	500Ω						Similar with unmodified
	TENS	50	48	52.5	48	50	device MT9000, different
	EMS	50	48	N/A	48	49	from Sonicator Plus940,
	Interferential	15.75	17.5	N/A	17.5	49	they all comply with IEC
	Microcurrent	0.4	0.36	N/A	0.36	0.38	60601-2-10.
	Russian	15.75	N/A	N/A	N/A	50
18	Max Output Current (mA) ±20%
	500Ω						Similar with unmodified
	TENS	100	96	105	96	100	device MT9000, different
	EMS	100	96	N/A	96	98	from Sonicator Plus940,
	Interferential	31.5	35	N/A	35	98	they all comply with IEC
	Microcurrent	0.8	0.76	N/A	0.76	0.76	60601-2-10.
	Russian	31.5	N/A	N/A	N/A	100
19	Pulse Width Range						Similar with unmodified
	TENS	50-400us	50-300us	100us~260us	50-300us	50-300us	device MT9000, different
	EMS	200~400us	50-300us	N/A	50-300us	500,250,200us	from Sonicator Plus940,
	Interferential	100/200/400us	125us	N/A	125us	500,250,200us	they all comply with IEC
	Microcurrent	2-200ms	2-200ms	N/A	2-200ms	1.25ms-1.67s	60601-2-10.
	Russian	400us	N/A	N/A	N/A	400us
20	Frequency
	TENS	1~150Hz	0.5-150Hz	50~150Hz	0.5-150Hz	0.5-250Hz
	EMS	1~100Hz	1-150Hz	N/A	1-150Hz	2kHz,4kHz,5kHz
	Interferential	2.5K,5K,10K Hz	4kHz	N/A	4kHz	2kHz,4kHz,5kHz
	MicrocurrentRussian	1-150Hz2.5kHz	1-150HzN/A	N/AN/A	1-150HzN/A	0.3-400Hz2.5kHz
21	Beat FrequencyInterferential	1-200Hz	1-150Hz	N/A	1-150Hz	1-250Hz
22	Timer Range (minutes)	5-90 minutes	0-60 minutes	15-60 minutes	0-60 minutes	0-60 minutes	Different, the treatmenttime doesn't affect thesafety and effectiveness
23	Compliance withVoluntary Standards?	IEC60601-1,IEC60601-1-2,IEC60601-2-10	IEC60601-1,IEC60601-1-2,IEC60601-2-10	IEC60601-1,IEC60601-1-2,IEC60601-2-10	IEC60601-1,IEC60601-1-2,IEC60601-2-10,MDD93/42/EEC,Annex II	IEC60601-1,IEC60601-1-2,IEC60601-2-10,MDD93/42/EEC, AnnexII	Similar
24	Compliance with 21CFR 898?	Yes	Yes	Yes	Yes	Yes	Same
25	Weight (Ibs.)	0.28	0.28	0.28	0.28	11	Different, the different
26	Dimensions (in.) H x Wx L	4.6x2.36x0.9	4.5x2.55x0.9	4.5x2.55x0.9	4.5x2.55x0.9	4.9x13.6x10.5	weight and dimensiondoesn't affect the safetyand effectiveness.
27	Housing Materials &Construction	Enclosure: ABS	Enclosure: ABS	Enclosure: ABS	Enclosure: ABS	Metal Casing	Different, but they allcomply with IEC 60601-1requirements.

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Image /page/12/Picture/0 description: The image is a logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and orange. The word "DONGDIXIN" is in large, bold, blue letters, with the "X" in "DIXIN" being orange. Below "DONGDIXIN" is the text "TECHNOLOGY CO., LTD." in smaller, blue letters. To the right of the text is a column of three Chinese characters.

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7. Performance Date:

The following performance data are provided in support of the substantial equivalence determination:

6.1 Biocompatibility testing

Compared with unmodified device, the new product MT9000 and Intensity 10 has the same accessories which has been evaluated based on the ISO10993 standard and submits to FDA (K093138).

The new product LT7102 added the electrode accessories like as different part electrode belt previously had been submitted with Shenzhen Dongdixin Technology Co., Ltd (K141076) which has been evaluated based on the ISO10993 standard and submit to FDA.

6.2 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the LT2061. The system complies with the IEC 60601-1 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.

6.3 Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern. IEC 62304 was followed.

8. Conclusions:

The LT7102, MT9000 and Intensity 10 have the same intended use and technological characteristics as the predicate device of Sonicator Plus 940, Model ME940 device and MT9000 Combo TENS/EMS/IF/MIC Stimulator. Moreover, bench testing and safety report supplied in this submission demonstrates that the difference in the submitted models could maintain the same safety and effectiveness as that of predicate device. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, the LT7102, MT9000 and Intensity 10 are substantially equivalent to the predicate device.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).