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

{0}------------------------------------------------ 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<br>per 21 CFR § 890.5850;<br>Stimulator, Nerve, Transcutaneous. For pain relief<br>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 {1}------------------------------------------------ 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<br>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: {2}------------------------------------------------ ・ 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<br>and EMS Stimulator,<br>FDES102(ED402) TENS<br>Stimulator,<br>FDES103(ED403) EMS<br>Stimulator | MT9000 Combo<br>TENS/EMS/IF/MIC<br>Stimulator<br>MT9001 TENS<br>Stimulator<br>MT9002 EMS Stimulator<br>MT9003 IF Stimulator<br>MT9004<br>MICROCURRENT<br>Stimulator | -- | | 3 | Manufacturer | Famidoc Technology Co.,<br>Ltd. | Shenzhen Dongdixin<br>Technology Co., Ltd. | -- | | 4 | Power Source | DC 6V, 4×1.5V AAA<br>batteries | 9V Battery | SE | | 4.1 | -Method of Line<br>current isolation | Battery Supply N/A | Battery Supply N/A | -- | | 4.2 | - Patient Leakage<br>Current<br>-Normal condition<br>-Single fault<br>condition | 3.0uA<br>5.8uA | 0.61uA<br>0.68uA | SE, meet<br>the<br>requiremen<br>ts of IEC<br>60601-1 | | 5 | Classification | | | -- | | 5.1 | Type of protection<br>against electric<br>shock | Internally powered<br>equipment | Internally powered<br>equipment | SE | | 5.5 | Degree of<br>protection against<br>electric shock | Type BF applied part | Type BF applied part | SE | | 5.3 | Device Class | Class II | Class II | SE | | 6 | Number of treatment<br>programs | FDES101(ED401)<br>30<br>FDES102(ED402)<br>15<br>FDES103(ED403)<br>15 | MT9000<br>4<br>MT9001<br>1<br>MT9002<br>1<br>MT9003<br>1<br>MT9004<br>1 | | | No. | Comparison item | New device | Predicate device | Judgment | | 7 | Number of Output<br>Channels | 2 | 2 | SE | | 7.1 | - Synchronous or<br>Alternating? | Synchronous and<br>Alternating | Synchronous and<br>Alternating | SE | | 7.2 | - Method of<br>Channel<br>Isolation? | By electrical circuit and<br>software | By electrical circuit and<br>software | SE | | 8 | Constant Current?<br>Constant Voltage? | Yes<br>No | Yes<br>No | SE | | 9 | Software/Firmware/<br>Microprocessor<br>Control? | Yes | Yes | SE | | 10 | Automatic Overload<br>Trip?<br>Automatic Over<br>Current Trip? | Yes<br>Yes | Yes<br>Yes | SE | | 11 | Automatic No Load<br>Trip? | Yes | Yes | SE | | 12 | Automatic Shut off? | Yes | Yes | SE | | 13 | Patient Override<br>Control? | No | No | SE | | 14 | Indication function | | | -- | | 14.1 | -On/Off Status? | Yes | Yes | SE | | 14.2 | -Voltage/Current<br>Level? | Yes | Yes | SE | | 14.3 | -Low Battery? | Yes | Yes | SE | | 15 | Timer Range<br>(minutes) | 0-60 minutes | 0-60 minutes | SE | | 16 | Housing materials | Plastic (ABS) enclosure | Plastic (ABS) enclosure | SE | | 17 | Target population | Patients who need<br>physiotherapy treatment | Patients who need<br>physiotherapy treatment | SE | | 18 | Performance | Use friendly interface,<br>easy to operate | Use friendly interface,<br>easy to operate | SE | | 19 | Treatment area | Any area (Except those<br>treatment area which<br>been described in the<br>user manual can not<br>use ) ), such as Hand,<br>Arm, Chest, Waist,<br>Buttock, Thigh, Calf,<br>back and low back etc. | Any area (Except those<br>treatment area which<br>been described in the<br>user manual can not<br>use ) ), such as Hand,<br>Arm, Chest, Waist,<br>Buttock, Thigh, Calf,<br>back and low back etc. | SE | | No. | Comparison item | New device | Predicate device | Judgment | | 20 | List of patient<br>contacting<br>material(s) | Electrode - Transparent<br>silica gel (same supplier<br>TOP-RANK)<br>Electrode cord - PVC<br>Enclosure - ABS<br>(AG15A1)<br>Belt clip -- ABS(AG15A1) | Electrode - Transparent<br>silica gel (same<br>supplier TOP-RANK)<br>Electrode cord - PVC .<br>Enclosure - ABS<br>(AG15A1)<br>Belt clip - ABS<br>(AG15A1) | SE | | 20.1 | Electrode lead wires | Compliance with 21CFR<br>898,<br>PVC plug:<br>L=1.15m, please see the<br>page 16 clause 7<br>Electrode cords of<br>Section-08-01 Device<br>Description for detailed. | Compliance with 21CFR<br>898,<br>PVC plug: φ<br>2mm,L=1.5m | SE | | 20.2 | Electrode pads | Compliance with ISO<br>10993-1, provided by<br>TOP-RANK. 50*50mm,<br>Transparent silica gel | Compliance with ISO<br>10993-1, provided by<br>TOP-RANK. 40*40mm,<br>Transparent silica gel | SE | | 21 | Standards | | | -- | | 21.1 | Biocompatibility | Compliant with<br>requirements of ISO<br>10993-5 and ISO<br>10993-10 standards | Compliant with<br>requirements of ISO<br>10993-5 and ISO<br>10993-10 standards | SE | | 21.2 | Mechanical Safety | Compliant with<br>requirements of IEC<br>60601-1, IEC 60601-2-10<br>safety standards | Compliant with<br>requirements of IEC<br>60601-1, IEC<br>60601-2-10 safety<br>standards | SE | | 21.3 | Electrical Safety | Compliant with<br>requirements of IEC<br>60601-1, IEC<br>60601-2-10, IEC<br>60601-1-2 safety<br>standards | Compliant with<br>requirements of IEC<br>60601-1, IEC 60601-2<br>-10, IEC 60601-1-2<br>safety standards | SE | | 21.4 | Energy delivered | The delivered energy is<br>limited according to<br>requirements of collateral<br>IEC 60601-2-10 safety<br>standards | The delivered energy is<br>limited according to<br>requirements of<br>collateral IEC<br>60601-2-10 safety<br>standards | SE | | 22 | Used at (hospital,<br>home, ambulances) | Physiotherapy clinics | Physiotherapy clinics | SE | | No. | Comparison item | New device | Predicate device | Judgment | | 23 | Operating<br>temperature and<br>humidity | 5-40°C<br>30%-75% | 5-40°C<br>30%-75% | SE | | 24 | Storage<br>temperature and<br>humidity | -10-50°C<br>10%-90% | -10-50°C<br>10%-90% | SE | | 25 | Weight (Ibs.) | 0.35 | 0.28 | SE | Section 05-Page 3 of 9 · {3}------------------------------------------------ File No: XW-Stimulator A-FDA-05 Version: 1.2 Data: Aug.20, 2012 Section 05-Page 4 of 9 . . . . . . · {4}------------------------------------------------ ・ · File No: XW-Stimulator A-FDA-05 Version: 1.2 Data: Aug.20, 2012 Section 05-Page 5 of 9 : ' . {5}------------------------------------------------ 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 Section 05-Page 6 of 9 {6}------------------------------------------------ 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 | Section 05-Page 7 of 9 {7}------------------------------------------------ . 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 {8}------------------------------------------------ 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. {9}------------------------------------------------ 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 {10}------------------------------------------------ ## 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 {11}------------------------------------------------ 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: {12}------------------------------------------------ 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