K Number

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

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 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 5. Maintaining or increasing range of motion. 6. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K093138

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on basic electrical stimulation parameters controlled by physical buttons and an LCD display. There is no mention of adaptive algorithms, learning capabilities, or any technology that would suggest AI/ML is incorporated. The performance studies listed are standard electrical safety and compatibility tests, not studies evaluating AI/ML performance.

Therapeutic

Yes
The device is clearly indicated for therapeutic purposes, including symptomatic relief of pain, relaxation of muscle spasms, increase of local blood flow circulation, prevention of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and prevention of venous thrombosis. These are all therapeutic applications.

Diagnostic

This device is a stimulator (TENS and EMS) used for pain relief, muscle relaxation, and rehabilitation purposes. It is therapeutic rather than diagnostic, as it applies electrical currents to treat conditions, not to identify or measure them.

SaMD (Software as a Medical Device)

The device description explicitly states it is a physical stimulator with a molded plastic case, LCD display, keypad, and battery storage compartment, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
The description of the FDES101(ED401) Series Stimulator clearly states it is a Transcutaneous Electrical Nerve Stimulator (TENS) and/or Electrical Muscle Stimulator (EMS).
Its intended use is for pain relief and muscle stimulation by applying electrical current to the skin.
The device description and intended use do not involve the analysis of any biological specimens.

Therefore, this device falls under the category of therapeutic medical devices rather than in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For TENS mode

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

For EMS mode

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

FDES102(ED402) TENS Stimulator

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

FDES103(ED403) EMS Stimulator

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

Product codes (comma separated list FDA assigned to the subject device)

IPF, GZJ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Any area (Except those treatment area which been described in the user manual can not use ) ), such as Hand, Arm, Chest, Waist, Buttock, Thigh, Calf, back and low back etc.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physiotherapy clinics

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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"

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093138

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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:	+86(755) 27864342
Fax:	+86(755) 27864151
Contact Person:	Cao Liang
Contact Title:	General Manager
Contact Email:	leon@famidoc.com

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, Powered
per 21 CFR § 890.5850;
Stimulator, Nerve, Transcutaneous. For pain relief
per 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

Section 05-Page 1 of 9

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

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
Legally
Marketed 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:

・

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

・

· ·

No.	Comparison item	New device	Predicate device	Judgment
1	510K#	K113010	K093138	--
2	Device Name	FDES101(ED401) TENS
and EMS Stimulator,
FDES102(ED402) TENS
Stimulator,
FDES103(ED403) EMS
Stimulator	MT9000 Combo
TENS/EMS/IF/MIC
Stimulator
MT9001 TENS
Stimulator
MT9002 EMS Stimulator
MT9003 IF Stimulator
MT9004
MICROCURRENT
Stimulator	--
3	Manufacturer	Famidoc Technology Co.,
Ltd.	Shenzhen Dongdixin
Technology Co., Ltd.	--
4	Power Source	DC 6V, 4×1.5V AAA
batteries	9V Battery	SE
4.1	-Method of Line
current isolation	Battery Supply N/A	Battery Supply N/A	--
4.2	- Patient Leakage
Current
-Normal condition
-Single fault
condition	3.0uA
5.8uA	0.61uA
0.68uA	SE, meet
the
requiremen
ts of IEC
60601-1
5	Classification			--
5.1	Type of protection
against electric
shock	Internally powered
equipment	Internally powered
equipment	SE
5.5	Degree of
protection against
electric shock	Type BF applied part	Type BF applied part	SE
5.3	Device Class	Class II	Class II	SE
6	Number of treatment
programs	FDES101(ED401)
30
FDES102(ED402)
15
FDES103(ED403)
15	MT9000
4
MT9001
1
MT9002
1
MT9003
1
MT9004
1
No.	Comparison item	New device	Predicate device	Judgment
7	Number of Output
Channels	2	2	SE
7.1	- Synchronous or
Alternating?	Synchronous and
Alternating	Synchronous and
Alternating	SE
7.2	- Method of
Channel
Isolation?	By electrical circuit and
software	By electrical circuit and
software	SE
8	Constant Current?
Constant Voltage?	Yes
No	Yes
No	SE
9	Software/Firmware/
Microprocessor
Control?	Yes	Yes	SE
10	Automatic Overload
Trip?
Automatic Over
Current Trip?	Yes
Yes	Yes
Yes	SE
11	Automatic No Load
Trip?	Yes	Yes	SE
12	Automatic Shut off?	Yes	Yes	SE
13	Patient Override
Control?	No	No	SE
14	Indication function			--
14.1	-On/Off Status?	Yes	Yes	SE
14.2	-Voltage/Current
Level?	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 need
physiotherapy treatment	Patients who need
physiotherapy treatment	SE
18	Performance	Use friendly interface,
easy to operate	Use friendly interface,
easy to operate	SE
19	Treatment area	Any area (Except those
treatment area which
been described in the
user manual can not
use ) ), such as Hand,
Arm, Chest, Waist,
Buttock, Thigh, Calf,
back and low back etc.	Any area (Except those
treatment area which
been described in the
user manual can not
use ) ), 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 patient
contacting
material(s)	Electrode - Transparent
silica gel (same supplier
TOP-RANK)
Electrode cord - PVC
Enclosure - ABS
(AG15A1)
Belt clip -- ABS(AG15A1)	Electrode - Transparent
silica gel (same
supplier TOP-RANK)
Electrode cord - PVC .
Enclosure - ABS
(AG15A1)
Belt clip - ABS
(AG15A1)	SE
20.1	Electrode lead wires	Compliance with 21CFR
898,
PVC plug:
L=1.15m, please see the
page 16 clause 7
Electrode cords of
Section-08-01 Device
Description for detailed.	Compliance with 21CFR
898,
PVC plug: φ
2mm,L=1.5m	SE
20.2	Electrode pads	Compliance with ISO
10993-1, provided by
TOP-RANK. 50*50mm,
Transparent silica gel	Compliance with ISO
10993-1, provided by
TOP-RANK. 40*40mm,
Transparent silica gel	SE
21	Standards			--
21.1	Biocompatibility	Compliant with
requirements of ISO
10993-5 and ISO
10993-10 standards	Compliant with
requirements of ISO
10993-5 and ISO
10993-10 standards	SE
21.2	Mechanical Safety	Compliant with
requirements of IEC
60601-1, IEC 60601-2-10
safety standards	Compliant with
requirements of IEC
60601-1, IEC
60601-2-10 safety
standards	SE
21.3	Electrical Safety	Compliant with
requirements of IEC
60601-1, IEC
60601-2-10, IEC
60601-1-2 safety
standards	Compliant with
requirements of IEC
60601-1, IEC 60601-2
-10, IEC 60601-1-2
safety standards	SE
21.4	Energy delivered	The delivered energy is
limited according to
requirements of collateral
IEC 60601-2-10 safety
standards	The delivered energy is
limited according to
requirements of
collateral IEC
60601-2-10 safety
standards	SE
22	Used at (hospital,
home, ambulances)	Physiotherapy clinics	Physiotherapy clinics	SE
No.	Comparison item	New device	Predicate device	Judgment
23	Operating
temperature and
humidity	5-40°C
30%-75%	5-40°C
30%-75%	SE
24	Storage
temperature and
humidity	-10-50°C
10%-90%	-10-50°C
10%-90%	SE
25	Weight (Ibs.)	0.35	0.28	SE

Section 05-Page 3 of 9

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

Section 05-Page 4 of 9

. . . . . .

・

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

Section 05-Page 5 of 9

' .

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 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.

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

For TENS mode

Section 05-Page 6 of 9

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

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

For EMS mode

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

FDES102(ED402) TENS Stimulator

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

FDES103(ED403) EMS Stimulator

1. Relaxation of muscle spasm.
1. Increase of blood flow circulation
1. Prevention or retardation of disuse atrophy
1. 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

Section 05-Page 7 of 9

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)

Section 05-Page 8 of 9

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.

Image /page/9/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, serif font. The text is centered on the image.

Image /page/9/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

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

Page 2 - Cao Liang

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 (800) 638-2041 or (301) 796-7100 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

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
1. Post traumatic pain
1. Post surgical pain

For EMS mode

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

FDES102(ED402) TENS Stimulator

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

FDES103(ED403) EMS Stimulator

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

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