LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR by SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.

Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
Increase of blood flow in the treatment area
Relaxation of muscle spasm
Immediate post-surgical stimulation of muscles to prevent venous thrombosis
Prevention or retardation of disuse atrophy
Muscle re-education
Maintaining or increasing range of motion.

LT3001 TENS Stimulator

Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain

LT3002 EMS Stimulator

Relaxation of muscle spasm.
Increase of blood flow in the treatment area
Immediate post-surgical stimulation of muscles to prevent venous thrombosis
Muscle re-education
Prevention or retardation of disuse atrophy
Maintaining or increasing range of motion.

Device Description

The LT3000 Series Stimulator, which includes models LT3000, LT3001 and LT3002, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group through the cable and electrode placed on the skin. The parameters of units are controlled by the rotate buttons. Its intensity level is adjustable according to the needs of patients.

The three models LT3000, LT3001 and LT3002 have the same housing in a molded portable plastic case, an accessible buttons、 switch, and accessible battery storage compartment. The case shape is rectangular. The process to set the parameter and attach lead wires to the three models is also the same except the Housing printing artwork, Mode No & destination.

The LT3000 Combo Stimulator is the combination unit with both TENS and EMS functions, the function can be selected by switch. The range of settings is identical to those of LT3001 and LT3002. The difference on the three units can be identified by printing artwork, Mode No.

AI/ML Overview

The acceptance criteria and study information for the LT3000 Series Electro-Stimulator are outlined below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

For the LT3000 Series Electro-Stimulator (K100117), the acceptance criteria for substantial equivalence were primarily based on technological characteristics and safety standards adherence. Since this is a 510(k) submission for a medical device that did not involve clinical trials for its substantial equivalence determination, the "reported device performance" is not in terms of clinical outcomes but rather conformance to established safety and performance benchmarks relative to a predicate device.

The presented information focuses on demonstrating that the new device meets the same safety and performance profiles as its predicate device through non-clinical testing and comparison of technical specifications.

Acceptance Criteria (Technological Characteristics & Safety)	Reported Device Performance (LT3000 Series)
Intended Use	Same as predicate device (Symptomatic pain relief, muscle relaxation, blood flow increase, etc.)
Fundamental Technology	Same as predicate device (Transcutaneous Electrical Nerve Stimulation & Electrical Muscle Stimulation)
Power Source	9V Battery
Method of Line current isolation	Battery Supply N/A
Patient Leakage Current (Normal)	1.1uA (Lower than predicate's 1.5uA)
Patient Leakage Current (Single fault)	1.3uA (Lower than predicate's 1.7uA)
Number of Output Modes	6 (Close to predicate's 7)
Number of Output Channels	2 Synchronous and Alternating
Method of channel isolation	By enclosure (Different from predicate's "By transformer" but deemed safe)
Regulated Current or Regulated Voltage?	Voltage control
Software/Firmware/Microprocessor Control?	Yes
Automatic Overload Trip?	No
Automatic Over Current Trip?	No
Automatic No Load Trip?	No
Automatic Shut off?	No
Patient Override Control?	No
Indicator Display (On/Off Status, Voltage/Current Level, Low Battery)	Yes for all
Timer Range (minutes)	30min, 60min, continue (Similar to predicate's 5~90minutes or continue)
Waveform	Biphasic Rectangular
Pulse Width Range	50-300us
Frequency	2-120Hz (Similar to predicate's 2-150Hz)
Compliance with Voluntary Standards (IEC60601-1, IEC60601-1-2)	Yes
Compliance with IEC 60601-2-10	Yes (for nerve and muscle stimulators)
Compliance with 21 CFR 898?	Yes
Biocompatibility of Electrodes	Electrodes from K070612 manufacturer.
Biocompatibility of Device Shell Material	ABS material passed testing in Jiangsu TUV Product Service Ltd. Shanghai Branch (Identification No: 080960).

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

The submission explicitly states: "The LT3000 Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards".

Therefore, there are no "test set" or "training set" in the context of patient data or clinical trials. The "test set" here refers to the actual devices being tested in a laboratory setting. There is no specific sample size mentioned for the number of devices tested, but it's implied that the non-clinical tests were conducted on representative samples of the LT3000 Series Electro-Stimulators.

The data provenance is from non-clinical bench testing conducted by the manufacturer (Shenzhen Dongdixin Technology Co., Ltd.) and relevant testing laboratories (e.g., Jiangsu TUV Product Service Ltd. Shanghai Branch for biocompatibility). This is considered retrospective in the sense that it's a report on tests already performed. The country of origin of the manufacturer is China.

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

Not applicable. As no clinical studies were performed, there was no test set requiring expert ground truth establishment in a clinical context. The "ground truth" for non-clinical tests is based on adherence to engineering and safety standards, and performance specifications.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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 electro-stimulator, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests was adherence to:

Voluntary design standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10 for medical electrical equipment safety.
Manufacturer's specified design requirements.
Biocompatibility test results for materials used.

Essentially, the ground truth was conformance to established engineering, safety, and material standards for medical devices of this type.

8. The Sample Size for the Training Set

Not applicable. No training set was used as this was not a machine learning or AI device, nor did it involve clinical data for performance validation.

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

Not applicable. No training set was used.

Summary

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K100117

JAN 2 9 2010

File No: WMI-04-LT3000-FDA-05 Version: 1.1 Data: Dec.10, 2009

510(k) SUMMARY

LT3000 Series Electro-Stimulator, K (

Date of Submission: 12/10/2009 Shenzhen Dongdixin Technology Co., Ltd. Submitter's Name: No.3bldg. xiliyangguang industrial estae Address: xilixiaobaimang Nanshan district Shenzhen, CHINA 518108 Telephone: +86(755) 27652471 Fax: +86(755) 27652674 E-mail: info@dundex.com

Zhigang Zhao

Contact:

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File No: WMI-04-LT3000-FDA-05 Version: 1.1 Data: Dec.10, 2009

1. Proposed Device:

Trade Name:	LT3000 Combo StimulatorLT3002 EMS Stimulator
Classification Name:	Stimulator, Muscle, Powered
Regulation Number:	890.5850
Product Code:	IPF
Device Class:	II

Trade Name:	LT3001 TENS Stimulator
Classification Name:	Stimulator, Nerve, Transcutaneous. For pain relief
Regulation Number:	882.5890
Product Code:	GZJ
Device Class:	II

2. Predicate Device:

Legally Marketed Device:	TENS/EMS Combo, TENS, EMS
510(k) Number:	K082514
Manufacturer:	MEDIHIGHTEC MEDICAL CO., LTD

3. Description of Proposed Device:

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File No: WMI-04-LT3000-FDA-05 Version: 1.1 Data: Dec.10, 2009

printing artwork, Mode No.

4. Proposed Device Intended Use Statement:

Device Name:

LT3000 Combo TENS/EMS Stimulator, LT3001 TENS Stimulator, LT3002 EMS

Stimulator

Indications for .Use:

LT3000 Combo Stimulator

Symptomatic relief of chronic intractable pain, acute post traumatic pain 】. or acute post surgical pain
1. Increase of blood flow in the treatment area
1. Relaxation of muscle spasm
Immediate post-surgical stimulation of muscles to prevent venous 4. thrombosis
Prevention or retardation of disuse atrophy 5.
1. Muscle re-education
1. Maintaining or increasing range of motion.

LT3001 TENS Stimulator

Symptomatic relief of chronic intractable pain, acute post traumatic pain 1. or acute post surgical pain

LT3002 EMS Stimulator

1. Relaxation of muscle spasm.
1. Increase of blood flow in the treatment area
Immediate post-surgical stimulation of muscles to prevent venous ന് thrombosis
1. Muscle re-education
റ് Prevention or retardation of disuse atrophy
Maintaining or increasing range of motion. 6.

5. · Biocompatibility Certification:

Electrodes to be provided with this device are from the manufacturer Top-Rank Health Care Equipment Co., Ltd (K070612) who submitted in 2007.

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File No: WMI-04-LT3000-FDA-05 Version: 1.1 Data: Dec.10, 2009

The shell of device is used ABS material; this material has passed Biocompatibility testing in Jiangsu TUV Product Service Ltd. Shanghai Branch Identification No: 080960.

6. Technological Characteristics and Substantial Equivalence

Both the LT3000 Series Electro-Stimulator and the Predicate device Stimulator have the same intended use and fundamental technology. A side-by-side comparison of the LT3000 Series Electro-Stimulator and the cited predicate devices is included in the 510(k) submission. The LT3000 Series Electro-Stimulator is substantially equivalent to the technological features as the predicate devices.

		New device	Predicate device
1	510K#	K	K082514
2	Device Name	LT3000 Combo StimulatorLT3001 TENS StimulatorLT3002 EMS Stimulator	MH8000/MH6000 TENS/EMS ComboMH8100/MH6100 EMS
3	Manufacturer	Shenzhen DongdixinTechnology Co., Ltd.	MH8200/MH6200 TENSMedihightec medical Co., Ltd
4	Power Source	9V Battery	9V Battery
	-Method of Line current isolation	Battery Supply N/A	Battery Supply N/A
	- Patient Leakage Current-Normal condition-Single fault condition	1.1uA	1.5uA
5		1.3uA	1.7uA
	Number of Output Modes	6	7
6	Number of Output Channels	2 Synchronous and Alternating	2 Synchronous and Alternating
	Method of channel isolation	By enclosure	By transformer
7	Regulated Current or regulated Voltage?	Voltage control	Voltage control
8	Software/Firmware/Microprocessor Control?	Yes	Yes
9	Automatic Overload Trip?	No	No
	Automatic Over Current Trip?	No	No
10	Automatic No Load Trip?	No	No
11	Automatic Shut off?	No	No
12	Patient Override Control?	No	No
13	Indicator Display
	-On/Off Status?	Yes	Yes
	-Voltage/Current Level?	Yes	Yes
	-Low Battery?	Yes	Yes
14	Timer Range (minutes)	30min, 60min, continue	5~90minutes or continue
15	Waveform	Biphasic Rectangular	Biphasic Rectangular

Basic technological characteristics, new device vs. Predicate device

Section 05-Page 4 of 5

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File No: WMI-04-LT3000-FDA-05 Version: 1.1 Data: Dec.10. 2009

16	Pulse Width Range	50-300us	50-300us
17	Frequency	2-120Hz	2-150Hz
18	Compliance with Voluntary Standards?	IEC60601-1, IEC60601-1-2,	IEC60601-1, IEC60601-1-2,
19	Compliance with 21 CFR 898?	Yes	Yes
20	Weight (grams.)	128 grams(battery included)	162grams(battery included)
21	Dimensions (cm.) L x W x H	10.2x6.4x2.6	13.6x7x2.7
22	Housing Materials & Construction	Enclosure: ABS,94, V-1,80°C,ULApproved	Enclosure: ABS,94, V-1,80°C,ULApproved

Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:

The LT3000 Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards:

ア IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for safety".
公 IEC 60601-1-2 "Medical electrical equipment - Part 1-2: General requirements for safety -Collateral Standard"
IEC 60601-2-10 "Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators"

8. Conclusions:

The LT3000 Series Stimulator, which includes models LT3000, LT3001 and LT3002, has the same intended use and technological characteristics as the predicate device. Moreover, bench testing, safety report and Risk Analysis Report documentation 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 LT3000 Series Electro-Stimulator is substantially equivalent to the predicate device.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling the image of an eagle. The eagle is stylized and abstract, with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Shenzhen Dongdixin Technology Co., LTD. % Underwriters Laboratories, Inc. Mr. Marc M. Mouser 2600 North West Lake Road Camas, Washington 98607

JAN 2 9 2010

Re: K100117

Trade/Device Name: LT3000 Combo Stimulator, LT3001 TENS Stimulator, LT3002 EMS Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, GZJ Dated: January 7, 2010 Received: January 15, 2010

Dear Mr. Mouser:

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 r hat 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 or any I 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 de reo related adverses overies) & 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. Marc M. Mouser

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic,

and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Caretalk®

Indications for Use

510(k) Number (

Device Name:

LT3000 Combo Stimulator, LT3001 TENS Stimulator, LT3002 EMS Stimulator

Indications for Use:

LT3000 Combo Stimulator

Symptomatic relief of chronic intractable pain, acute post traumatic pain or 1. acute post surgical pain
Increase of blood flow in the treatment area 2.
1. Relaxation of muscle spasm
Immediate post-surgical stimulation of muscles to prevent venous 4. thrombosis
Prevention or retardation of disuse atrophy క.
Muscle re-education 6.
Maintaining or increasing range of motion. 7.

LT3001 TENS Stimulator

1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain

LT3002 EMS Stimulator

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

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

YAUUAN B. FOR M.MELKERSON

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100117 Section 04 - Page 1 of 1

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).