FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR

• K Number: K113010
• Device Name: FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
• Manufacturer: FAMIDOC TECHNOLOGY CO., LTD
• Date Cleared: 2012-12-21 ( 437 days)
• Product Code: IPF , GZJ
• Regulation Number: 890.5850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: K093138
• Predicate For: K181688 , K183074

Intended Use

FDES101(ED401) TENS and EMS Stimulator
For TENS 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
   FDES102(ED402) TENS Stimulator
10. Symptomatic relief of chronic intractable pain
11. Post traumatic pain
12. Post surgical pain
    FDES103(ED403) EMS Stimulator
13. Relaxation of muscle spasm.
14. Increase of blood flow circulation
15. Prevention or retardation of disuse atrophy
16. Muscle re-education
17. Maintaining or increasing range of motion.
18. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Device Description

The FDES101(ED401) Series Stimulator, which includes models FDES101(ED401), FDES102(ED402) and FDES103(ED403), 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 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 FDES101(ED401), FDES102(ED402) and FDES103(ED403) have the same housing in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular. 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.
The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it. The process to set the parameter and attach lead wires to the five models is also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings.
The FDES101(ED401) TENS and EMS Stimulator is the combination unit with the TENS. EMS functions, the function can be selected by press buttons. The range of settings is identical to those of FDES102(ED402) and FDES103(ED403). The difference on the five units can be identified by the LCD display.

AI/ML Overview

The provided document is a 510(k) Summary for FAMIDOC TECHNOLOGY CO., LTD.'s FDES101 (ED401) Series Electro-Stimulator. It focuses on demonstrating substantial equivalence to a predicate device rather than providing the results of a de novo study with specific acceptance criteria and performance metrics typically associated with AI/ML device evaluations. Therefore, many of the requested elements are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract the information relevant to non-clinical testing for substantial equivalence and general device specifications.

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, the "acceptance criteria" for performance are typically substantial equivalence to a predicate device and compliance with relevant safety and performance standards. The "reported device performance" is demonstrated through these comparisons and adherence to standards.

Acceptance Criteria (Demonstration of Substantial Equivalence and Safety)	Reported Device Performance (as compared to predicate and standards)
Functional Equivalence to Predicate Device	The FDES101(ED401) Series Electro-Stimulator is stated to be "basically the same" as the predicate device (MT9000 Series Electro-Stimulator, K093138) in "design, function, materials, operational principles and intended use."
Patient Leakage Current (Normal Condition)	Acceptance: Meet requirements of IEC 60601-1.
Reported Performance: 3.0 uA (New Device) vs. 0.61 uA (Predicate). Judged as "SE, meet the requirements of IEC 60601-1."
Patient Leakage Current (Single Fault Condition)	Acceptance: Meet requirements of IEC 60601-1.
Reported Performance: 5.8 uA (New Device) vs. 0.68 uA (Predicate). Judged as "SE, meet the requirements of IEC 60601-1."
Type of protection against electric shock	Reported Performance: Internally powered equipment (New Device) vs. Internally powered equipment (Predicate). Judged as "SE" (Substantially Equivalent).
Degree of protection against electric shock	Reported Performance: Type BF applied part (New Device) vs. Type BF applied part (Predicate). Judged as "SE".
Device Class	Reported Performance: Class II (New Device) vs. Class II (Predicate). Judged as "SE".
Number of Output Channels	Reported Performance: 2 (New Device) vs. 2 (Predicate). Judged as "SE".
Synchronous or Alternating Output	Reported Performance: Synchronous and Alternating (New Device) vs. Synchronous and Alternating (Predicate). Judged as "SE".
Method of Channel Isolation	Reported Performance: By electrical circuit and software (New Device) vs. By electrical circuit and software (Predicate). Judged as "SE".
Constant Current? Constant Voltage?	Reported Performance: Yes/No (New Device) vs. Yes/No (Predicate). Judged as "SE".
Software/Firmware/Microprocessor Control?	Reported Performance: Yes (New Device) vs. Yes (Predicate). Judged as "SE".
Automatic Overload/Over Current Trip?	Reported Performance: Yes/Yes (New Device) vs. Yes/Yes (Predicate). Judged as "SE".
Automatic No Load Trip?	Reported Performance: Yes (New Device) vs. Yes (Predicate). Judged as "SE".
Automatic Shut off?	Reported Performance: Yes (New Device) vs. Yes (Predicate). Judged as "SE".
Patient Override Control?	Reported Performance: No (New Device) vs. No (Predicate). Judged as "SE".
Indication Function (On/Off, Voltage/Current Level, Low Battery)	Reported Performance: Yes for all (New Device) vs. Yes for all (Predicate). Judged as "SE".
Electrical Safety Standards Compliance	Acceptance: Compliant with requirements of IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 safety standards.
Reported Performance: "Compliant with requirements of IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 safety standards." Judged as "SE".
Mechanical Safety Standards Compliance	Acceptance: Compliant with requirements of IEC 60601-1, IEC 60601-2-10 safety standards.
Reported Performance: "Compliant with requirements of IEC 60601-1, IEC 60601-2-10 safety standards." Judged as "SE".
Biocompatibility Standards Compliance	Acceptance: Compliant with requirements of ISO 10993-5 and ISO 10993-10 standards. Biocompatibility testing report provided (Report No: RZ106309 for ABS shell) and electrodes from a cleared supplier (K070612). Reported Performance: "Compliant with requirements of ISO 10993-5 and ISO 10993-10 standards." Judged as "SE".
Energy Delivery Limits	Acceptance: Limited according to requirements of collateral IEC 60601-2-10 safety standards.
Reported Performance: "The delivered energy is limited according to requirements of collateral IEC 60601-2-10 safety standards." Judged as "SE".

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

This document describes a 510(k) submission for an electro-stimulator, which is a hardware device. It demonstrates substantial equivalence through comparisons to a predicate device and adherence to international safety and performance standards.

• No "test set" in the context of AI/ML performance evaluation (e.g., retrospective vs. prospective data, country of origin) is mentioned or applicable here.
• The comparison is based on the technical specifications and safety testing of the device itself and its components, against those of a predicate device and industry standards.

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. This is a hardware device submission, not specifically an AI/ML diagnostic or prognostic device that requires expert-established ground truth for a test set.

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

Not applicable, as there is no "test set" or human expert review process described for performance evaluation in the context of an AI/ML device.

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 is a hardware device submission, not an AI/ML device intended to assist human readers. The document explicitly states: "The FDES101(ED401) Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence."

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

Not applicable. The device is a physical electro-stimulator, not an algorithm.

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

Not applicable. For this type of device, "ground truth" relates to compliance with engineering and safety standards, and functional equivalence to an already legally marketed device, rather than diagnostic accuracy against a clinical reference standard. The "proof" is through non-clinical bench testing and comparative analysis of specifications against predicate devices.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.

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

Not applicable. As above, this is a hardware device, and the concept of a training set and its ground truth is not relevant to this submission.

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Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (which in this 510(k) context is primarily substantial equivalence to a predicate device and compliance with recognized safety standards) is a non-clinical bench testing and comparative analysis study.

• The document explicitly states: "The FDES101(ED401) 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:"

  • IEC 60601-1 "Medical electrical equipment Part 1: General requirements for safety".
  • IEC 60601-1-2 "Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility- Requirements and tests, Interpretation Sheet."
  • IEC 60601-1-4 "Medical electrical equipment Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems"
  • IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators"

• Evidence of Compliance: The submission includes bench testing results, safety reports, and a Risk Analysis Report to demonstrate that any engineering differences from the predicate device "do not affect the intended use or alter the fundamental scientific technology of the device," thus maintaining "the same safety and effectiveness as that of predicate device." Specific comparisons like power source, patient leakage current, electrical/mechanical safety classifications, and material properties are presented.

• Data Provenance: The comparative data is derived from the technical specifications and test results of the new device manufactured by Famidoc Technology Co., Ltd. (China) and the predicate device (MT9000 Series Electro-Stimulator, K093138, manufactured by Shenzhen Dongdixin Technology Co., Ltd.). This is a retrospective comparison based on existing device specifications and non-clinical test data.

Summary

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KIISOID

File No: XW-Stimulator A-FDA-05 Version: 1.2 Data: Aug.20, 2012

DEC 2 1 2012

510(k) SUMMARY

[As required by 21CFR 807.92]

FDES101(ED401) Series Electro-Stimulator, K (

1. Submitter's Information [21CFR 807.92(a)(1)]

Company Name:	Famidoc Technology Co., Ltd
Street Address:	East 2/F Zhixiang Building, 71 Block Baoan District
City:	Shenzhen
State/ Province:	Guangdong
Country:	China
Telephone:	[phone]
Fax:	[phone]
Contact Person:	Cao Liang
Contact Title:	General Manager
Contact Email:	[e-mail]

Trade Name, Common Name, Classification [21CFR 807.92(a)(2)] 2.

a) Trade Name:	FDES101(ED401) TENS and EMS Stimulator
Common Name:	Electro-Stimulator or Electrical Stimulator
Classification Name:	Stimulator, Muscle, Poweredper 21 CFR § 890.5850;Stimulator, Nerve, Transcutaneous. For pain reliefper 21 CFR § 882.5890
Device Class:	Class II
Product Code:	IPF, GZJ
a) Trade Name:	FDES102(ED402) TENS Stimulator
Common Name:	TENS or TENS Device
Classification Name:	Stimulator, Nerve, Transcutaneous. For pain relief

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Device Class:	per 21 CFR § 882.5890
	Class II
Product Code:	GZJ
b) Trade Name:	FDES103(ED403) TENS Stimulator
Common Name:	EMS or EMS Device
Classification Name:	Stimulator, Muscle, Powered
	per 21 CFR § 890.5850;
Device Class:	Class II
Product Code:	IPF

Identification of Predicate Device(s)[21 CFR 807.92(a)(3)] a)

PREDICATE DEVICES
Manufacturer	Shenzhen Dongdixin Technology Co., Ltd
LegallyMarketed Device	MT9000 Series Electro-Stimulator
510 (K) Number	K093138

There are basically the same between the FDES101(ED401) Series Electro-Stimulator and the predicate device which would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended . use. The detailed differences between them please see below:

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No.	Comparison item	New device	Predicate device	Judgment
1	510K#	K113010	K093138	--
2	Device Name	FDES101(ED401) TENSand EMS Stimulator,FDES102(ED402) TENSStimulator,FDES103(ED403) EMSStimulator	MT9000 ComboTENS/EMS/IF/MICStimulatorMT9001 TENSStimulatorMT9002 EMS StimulatorMT9003 IF StimulatorMT9004MICROCURRENTStimulator	--
3	Manufacturer	Famidoc Technology Co.,Ltd.	Shenzhen DongdixinTechnology Co., Ltd.	--
4	Power Source	DC 6V, 4×1.5V AAAbatteries	9V Battery	SE
4.1	-Method of Linecurrent isolation	Battery Supply N/A	Battery Supply N/A	--
4.2	- Patient LeakageCurrent-Normal condition-Single faultcondition	3.0uA5.8uA	0.61uA0.68uA	SE, meettherequirements of IEC60601-1
5	Classification			--
5.1	Type of protectionagainst electricshock	Internally poweredequipment	Internally poweredequipment	SE
5.5	Degree ofprotection againstelectric shock	Type BF applied part	Type BF applied part	SE
5.3	Device Class	Class II	Class II	SE
6	Number of treatmentprograms	FDES101(ED401)30FDES102(ED402)15FDES103(ED403)15	MT90004MT90011MT90021MT90031MT90041
No.	Comparison item	New device	Predicate device	Judgment
7	Number of OutputChannels	2	2	SE
7.1	- Synchronous orAlternating?	Synchronous andAlternating	Synchronous andAlternating	SE
7.2	- Method ofChannelIsolation?	By electrical circuit andsoftware	By electrical circuit andsoftware	SE
8	Constant Current?Constant Voltage?	YesNo	YesNo	SE
9	Software/Firmware/MicroprocessorControl?	Yes	Yes	SE
10	Automatic OverloadTrip?Automatic OverCurrent Trip?	YesYes	YesYes	SE
11	Automatic No LoadTrip?	Yes	Yes	SE
12	Automatic Shut off?	Yes	Yes	SE
13	Patient OverrideControl?	No	No	SE
14	Indication function			--
14.1	-On/Off Status?	Yes	Yes	SE
14.2	-Voltage/CurrentLevel?	Yes	Yes	SE
14.3	-Low Battery?	Yes	Yes	SE
15	Timer Range(minutes)	0-60 minutes	0-60 minutes	SE
16	Housing materials	Plastic (ABS) enclosure	Plastic (ABS) enclosure	SE
17	Target population	Patients who needphysiotherapy treatment	Patients who needphysiotherapy treatment	SE
18	Performance	Use friendly interface,easy to operate	Use friendly interface,easy to operate	SE
19	Treatment area	Any area (Except thosetreatment area whichbeen described in theuser manual can notuse ) ), such as Hand,Arm, Chest, Waist,Buttock, Thigh, Calf,back and low back etc.	Any area (Except thosetreatment area whichbeen described in theuser manual can notuse ) ), such as Hand,Arm, Chest, Waist,Buttock, Thigh, Calf,back and low back etc.	SE
No.	Comparison item	New device	Predicate device	Judgment
20	List of patientcontactingmaterial(s)	Electrode - Transparentsilica gel (same supplierTOP-RANK)Electrode cord - PVCEnclosure - ABS(AG15A1)Belt clip -- ABS(AG15A1)	Electrode - Transparentsilica gel (samesupplier TOP-RANK)Electrode cord - PVC .Enclosure - ABS(AG15A1)Belt clip - ABS(AG15A1)	SE
20.1	Electrode lead wires	Compliance with 21CFR898,PVC plug:L=1.15m, please see thepage 16 clause 7Electrode cords ofSection-08-01 DeviceDescription for detailed.	Compliance with 21CFR898,PVC plug: φ2mm,L=1.5m	SE
20.2	Electrode pads	Compliance with ISO10993-1, provided byTOP-RANK. 50*50mm,Transparent silica gel	Compliance with ISO10993-1, provided byTOP-RANK. 40*40mm,Transparent silica gel	SE
21	Standards			--
21.1	Biocompatibility	Compliant withrequirements of ISO10993-5 and ISO10993-10 standards	Compliant withrequirements of ISO10993-5 and ISO10993-10 standards	SE
21.2	Mechanical Safety	Compliant withrequirements of IEC60601-1, IEC 60601-2-10safety standards	Compliant withrequirements of IEC60601-1, IEC60601-2-10 safetystandards	SE
21.3	Electrical Safety	Compliant withrequirements of IEC60601-1, IEC60601-2-10, IEC60601-1-2 safetystandards	Compliant withrequirements of IEC60601-1, IEC 60601-2-10, IEC 60601-1-2safety standards	SE
21.4	Energy delivered	The delivered energy islimited according torequirements of collateralIEC 60601-2-10 safetystandards	The delivered energy islimited according torequirements ofcollateral IEC60601-2-10 safetystandards	SE
22	Used at (hospital,home, ambulances)	Physiotherapy clinics	Physiotherapy clinics	SE
No.	Comparison item	New device	Predicate device	Judgment
23	Operatingtemperature andhumidity	5-40°C30%-75%	5-40°C30%-75%	SE
24	Storagetemperature andhumidity	-10-50°C10%-90%	-10-50°C10%-90%	SE
25	Weight (Ibs.)	0.35	0.28	SE

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File No: XW-Stimulator A-FDA-05 Version: 1.2 Data: Aug.20, 2012

Description of Device[21 CFR 807.92(a)(4)] b)

The FDES101(ED401) Series Stimulator, which includes models FDES101(ED401), FDES102(ED402) and FDES103(ED403), 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 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 FDES101(ED401), FDES102(ED402) and FDES103(ED403) have the same housing in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular. 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.
  • The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it. The process to set the parameter and attach lead wires to the five models is also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings.

The FDES101(ED401) TENS and EMS Stimulator is the combination unit with the TENS. EMS functions, the function can be selected by press buttons. The range of settings is identical to those of FDES102(ED402) and FDES103(ED403). The difference on the five units can be identified by the LCD display.

Intended Use[21 CFR 807.92(a)(5)] c) FDES101(ED401) TENS and EMS Stimulator

For TENS mode

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File No: XW-Stimulator A-FDA-05 Version: 1.2 . Data: Aug.20, 2012

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

For EMS 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 calf muscles to prevent venous thrombosis

FDES102(ED402) TENS Stimulator

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

FDES103(ED403) EMS Stimulator

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

Technological Characteristics[21 CFR 807.92(a)(6)] d)

a) For TENS and EMS Stimulator FDES101(ED401)

Model:	FDES101(ED401)
Use Output Channels:	Two independent output channels
Intensity:	0-60 levels adjustable
Output Amplitude:	0-60mA adjustable (at 1000ohm load)
Treatment Mode:	TENS, EMS

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File No: XW-Stimulator A-FDA-05 Version: 1.2 . Data: Aug.20, 2012 ,

Pulse Width: 50-300uS : ・

Pulse Frequency:	0.5-150Hz
Treatment Time:	1-60minutes adjustable and default 30minutes
Output Plus Wave:	Bi-phase square wave
Power Supply:	4×1.5V AAA batteries, DC 6V
Weight:	0.35 Ibs (With batteries) .
Device Dimensions:	129.7×76×35.1mm(L×W×H)

b) For TENS Stimulator FDES102(ED402)

Model:	FDES102(ED402)
Use Output Channels:	Two independent output channels
Intensity:	0-60 levels adjustable
Output Amplitude:	0-60mA adjustable (at 1000ohm load)
Treatment Mode:	TENS
Pulse Width:	50-300uS
Pulse Frequency:	0.5-150Hz
Treatment Time:	1-60minutes adjustable and default 30minutes
Output Plus Wave:	Bi-phase square wave
Power Supply:	4 × 1.5V AAA batteries, DC 6V
Weight:	0.35 Ibs (With batteries)
Device Dimensions:	129.7×76×35.1mm(L×W×H)

c) For EMS Stimulator FDES103(ED403)

Model:	FDES103(ED403)
Use Output Channels:	Two independent output channels
Intensity:	0-60 levels adjustable
Output Amplitude:	0-60mA adjustable (at 1000ohm load)
Treatment Mode:	EMS
Pulse Width:	50-300uS
Pulse Frequency:	1-150Hz
Treatment Time:	1-60minutes adjustable and default 30minutes
Output Plus Wave:	Bi-phase square wave
Power Supply:	4 × 1.5V AAA batteries, DC 6V
Weight:	0.35 lbs (With batteries)
Device Dimensions:	129.7×76×35.1mm(L×W×H)

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File No: XW-Stimulator A-FDA-05 Version: 1.2 Data: Aug.20, 2012

e) 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.

The shell of device is used ABS material; this material has passed Biocompatibility i testing in Guanzhou Medical Instruments Quality Surveillance and Inspection Center of State Food and Drug Administration, Report No: RZ106309.

Discussion of Non-Clinical Tests Performed for Determination of f) Substantial Equivalence are as follows

The FDES101(ED401) 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:

• IEC 60601-1 "Medical electrical equipment Part 1: General requirements for safety".

• IEC 60601-1-2 "Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility- Requirements and tests, Interpretation Sheet."

• IEC 60601-1-4 "Medical electrical equipment Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

• IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators"

g) Conclusions

The FDES101(ED401) Series Stimulator, which includes models FDES102(ED402) and FDES103(ED403), has the same intended use and technological characteristics as the predicate device of MT9000 Series Electro-Stimulator, Model MT9000. 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 FDES101(ED401) Series Electro-Stimulator is substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Public Health Service

December 21, 2012

Famidoc Technology Co., Ltd. % Cao Liang East 2/F. Zhixiang Building 71 Block Baoan District Shenzhen, Guangdong China 518101

Re: K113010

Trade/Device Name: FDES101 (ED401) TENS and EMS Stimulator, FDES102 (ED402) TENS Stimulator, FDES103 (ED403) EMS Stimulator Regulation Number: 21 CFR 890.5850

Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: November 28, 2012 Received: November 28, 2012

Dear Cao Liang:

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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Victor Krauthamer -A

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Famiooc

File No: XW-Stimulator A-FDA-04 Version: 1.1 Data: May.3, 2012

Indications for Use

510(k) Number: K113010

Device Name: EDES101(ED401) TENS and EMS Stimulator, FDES102(ED402) TENS Stimulator, FDES103(ED403) EMS Stimulator

Indications for Use:

FDES101(ED401) TENS and EMS Stimulator

For TENS mode

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

For EMS 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 calf muscles to prevent venous thrombosis

FDES102(ED402) TENS Stimulator

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

FDES103(ED403) EMS Stimulator

• 1. Relaxation of muscle spasm.
• 2. Increase of blood flow circulation
• Prevention or retardation of disuse atrophy 3.
• Muscle re-education ধ:

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File No: XW-Stimulator A-FDA-04 Version: 1.1 Data: May.3, 2012

• Maintaining or increasing range of motion. ട.
• Immediate post-surgical stimulation of calf muscles to prevent 6. venous thrombosis

Prescription Use (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)

Brian D. Pullin -S

Division of Neurological and Physical Medicine Devices 510(k) Number: K113010

Section 04 -Page 2 of 2

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).