(90 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The software mentioned controls basic device functions and waveform characteristics, which is typical for such devices and does not imply AI/ML.
Yes
The device is described as providing temporary relief of pain and stimulating muscles to improve performance, which are therapeutic functions.
No
Explanation: The device is intended for pain relief and muscle stimulation, not for diagnostics. Its functions (TENS and EMS) are therapeutic in nature, aimed at temporary relief of pain and improving muscle performance, without any stated diagnostic capabilities to identify or analyze disease or conditions.
No
The device description clearly states it is a "small battery operated OTC device" that provides TENS/EMS and heat, indicating it is a physical hardware device with integrated software control. It also mentions physical components like electrode pads and cables.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Heat StimPlus Function: The description clearly states the Heat StimPlus is a device that applies electrical stimulation (TENS/EMS) and heat directly to the body's surface for pain relief and muscle stimulation. It does not involve the analysis of any biological specimens.
The intended use and device description focus on external application and physical effects, which are characteristic of therapeutic or physical medicine devices, not IVDs.
N/A
Intended Use / Indications for Use
The Heat StimPlus, Model FDES115 is intended
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
Product codes
NUH, NGX
Device Description
The Heat StimPlus (Model:FDES115) is a small battery operated OTC device that provides a combination of TENS/EMS and heat for a warming sensation.
It delivers TENS/EMS only or alternating combinations of TENS/EMS and heat. TENS/EMS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion battery. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
FDES 115 feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general well-being, pain relief, maintaining physical fitness, relaxation, muscle revitalization and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.
Stimulation from FDES115 is intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls all controls and indicators. Software controls waveform characteristics.
The accessories include: Type-C cable, an electrode cord / cable attached to electrodes pads and a Pad holder for storage.
The electrode pads allow for stimulation and have resistive elements to provide heat which is powered by the FDES115. The electrodes cleared include the electrode patches/pads and electrode garments. which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients used in the electrode patch/pad may be withheld as the trade secret.
The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device.
The FDES115 is considered - OTC devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, upper extremities (arm), lower extremities (leg), lower back, arms, legs, shoulder, foot
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
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
No clinical testing was performed.
Non-Clinical Data:
- Biocompatibility testing: Conducted in accordance with ISO 10993-1. Included Cytotoxicity, Skin Sensitization, and Skin Irritation tests. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours.
- Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1: 2012 and IEC 60601-1-2: 2014.
- Bench Testing: Complies with IEC 60601-1-11: 2015 and IEC 60601-2-10.
- Software Verification and Validation Testing: Documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "Moderate" level of concern.
- Usability Testing: Conducted according to FDA Guidance 1757, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design".
Key Metrics
Not Found
Predicate Device(s)
K203574 HIVOX OTC Electrical Stimulator EM59-2
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
December 13, 2021
Famidoc Technology Co., Ltd. Amos Zou Management Representative No.212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town Dongguan, Guangdong 523853 China
Re: K212918
Trade/Device Name: Heat StimPlus Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: September 8, 2021 Received: September 14, 2021
Dear Amos Zou:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212918
Device Name Heat StimPlus (Model FDES115)
Indications for Use (Describe)
The Heat StimPlus, Model FDES115 is intended
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for "FAMIDOC". The logo is in a sans-serif font and is a dark gray color. Below the logo is the tagline "CARING FOR YOUR FAMILY" in a smaller, sans-serif font. The "O" in "DOC" has a plus sign in the middle of it, and there is a registered trademark symbol next to the "C".
510(K) SUMMARY
This summary of 510(K) safety and effective information is being submitted in accordance with the requirement SMDA and 21 CFR 807.92.
1. Submitter of 510(K):
| Date of Prepared: | 12/07/2021 |
|---|---|
| Submitter's Name: | Famidoc Technology Co., Ltd. |
| Address: | No.212 Yilong Road, Hexi Industrial Zone,Jinxia ,Changan Town, |
| Dongguan City, Guangdong Province,523853,P.R.China | |
| Contact person: | Mr. Amos Zou |
| TEL: | +86-769-89272488 |
| FAX: | +86-769-89272498 |
| Email: | qa@famidoc.com |
2. Proposed Device and code:
| Device name: | Heat StimPlus |
|---|---|
| Model: | FDES115 |
| Classification product code: | NUH |
| Subsequent product code: | NGX |
| Regulation number: | 1) 882.5890 |
| 2) 890.5850 | |
| Regulation description: | 1) Transcutaneous electrical nerve stimulator for pain relief |
| 2) Powered muscle stimulator | |
| Review panel: | 1) Neurology |
| 2) Physical Medicine | |
| Device class: | II |
| Sterilization facility | Not applicable |
| Type: | Traditional |
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Image /page/4/Picture/0 description: The image shows the logo for FAMIDOC. The logo is in a sans-serif font and is a dark gray color. The word "FAMIDOC" is written in all capital letters. There is a plus sign inside of a circle in the middle of the word. There is a registered trademark symbol to the right of the letter C. Below the logo, the words "CARING FOR YOUR FAMILY" are written in a smaller font.
3. Predicate Device:
| 510(K) | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K203574 | HIVOX OTC Electrical Stimulator EM59-2 | HIVOX BIOTEK INC. |
4. Description of Proposed Device:
The Heat StimPlus(Model:FDES115) is a small battery operated OTC device that provides a combination of TENS/EMS and heat for a warming sensation.
It delivers TENS/EMS only or alternating combinations of TENS/EMS and heat. TENS/EMS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion battery. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
FDES 115 feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation, muscle revitalization and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.
Stimulation from FDES115 is intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls all controls and indicators. Software controls waveform characteristics.
The Heat StimPlus(Model:FDES115) is intended for:
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
The accessories include:Type-C cable,an electrode cord / cable attached to electrodes pads and a Pad holder for storage.
The electrode pads allow for stimulation and have resistive elements to provide heat which is powered by the FDES115The electrodes cleared include the electrode patches/pads and electrode garments. which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients used in the electrode patch/pad may be withheld as the trade secret.
The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device.
The FDES115 is considered - OTC devices.
Patient Population:Adults
న్. Intended for Use
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
6. Technical and Performance
The following table compares the device to the predicate device with basic technological characteristics.
Heat StimPlus(Model:FDES115) has been compared to the HIVOX OTC Electrical Stimulator. Model:EM59-2(K203574) as a predicate device for substantial equivalence. A table comparing the two devices is provided as follows:
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| Feature | Predicate Device | Proposed Device | |
|---|---|---|---|
| 510(k) No. | K203574 | K212918 | |
| Device Name | HIVOX OTC Electrical Stimulator | Heat StimPlus | |
| Model | EM59-2 | FDES115 | |
| Manufacturer | HIVOX BIOTEK INC. | Famidoc Technology Co., Ltd. | |
| Intended Use | TENS: This function is designed to be used for | ||
| temporary relief of pain associated with sore and | |||
| aching muscles in the shoulder, waist, back, upper | |||
| extremities (arm) | |||
| and lower extremities (leg) due to strain from | |||
| exercise or normal household work activities. |
EMS: This function is designed to be used for
stimulating healthy muscles in order to improve and
facilitate muscle performance.
SH: This function is designed to be used for
temporary relief of minor aches and pains. | TENS: This function is designed to be used for
temporary relief of pain associated with sore and
aching muscles in the shoulder, waist, back, upper
extremities (arm)
and lower extremities (leg) due to strain from
exercise or normal household work activities.
EMS: This function is designed to be used for
stimulating healthy muscles in order to improve and
facilitate muscle performance. | |
| Prescription or OTC | OTC | OTC | |
| FDA Product Code | NUH, NGX, IRT | NUH, NGX, | |
| Power Source(s) | Rechargeable battery | Rechargeable battery | |
| Function and Design | Electrical stimulation and heat | Electrical stimulation and heat | |
| Heating Setting | Low and high | Low and high | |
| Maximum Temperature
Setting | | 43°C | 43°C |
| Maximum
Output Voltage
(Vp, ±20%) | @ 500 Ω | 50.0 | 35 |
| | @ 2 kΩ | 90.0 | 75 |
| | @ 10 kΩ | 125 | 88 |
| Maximum
Output Current
(mAp, ±20%) | @ 500 Ω | 100 | 70 |
| | @ 2 kΩ | 45.0 | 37.5 |
| | @ 10 kΩ | 12.5 | 8.8 |
| Pulse Period (µs) | | 50 to 450 | 200 to 250 |
| Frequency (Hz) | | 1 to 150 | 1 to 150 |
| Maximum Phase Charge
(μC @ 500Ω) | | 45 | 12.6 |
| Maximum Current Density
(mA/cm2 @ 500Ω) | | 0.667 | 0.63 |
| Maximum Power Density
(W/cm2 @ 500Ω) | | 0.0046 | 0.00294 |
| Output Patterns | | Electrical stimulation only
Heat only
Electrical stimulation+ Heat simultaneously | Electrical stimulation only
Electrical stimulation+ Heat simultaneously |
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Image /page/6/Picture/0 description: The image shows the logo for FAMIDOC. The logo is in gray and consists of the word "FAMIDOC" in a sans-serif font, with a plus sign inside of the letter "O". Above the upper right corner of the letter "C" is the registered trademark symbol. Below the logo is the text "CARING FOR YOUR FAMILY".
| Comparison item | Predicate device | Subject device | |
|---|---|---|---|
| 510(k) Number | K203574 | K212918 | |
| Device Name | HIVOX OTC Electrical Stimulator | Heat StimPlus | |
| Model | EM59-2 | FDES115 | |
| Manufacturer | HIVOX BIOTEK INC. | Famidoc Technology Co., Ltd. | |
| Intended use | TENS: This function is designed to be used for | ||
| temporary relief of pain associated with sore and | |||
| aching muscles in the shoulder, waist, back, upper | |||
| extremities (arm) and lower extremities (leg) due to | |||
| strain from exercise or normal household work | |||
| activities. |
EMS: This function is designed to be used for
stimulating healthy muscles in order to improve and
facilitate muscle performance.
SH: This function is designed to be used for
temporary relief of minor aches and pains. | TENS: This function is designed to be used for
temporary relief of pain associated with sore and
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance. |
| Prescription or OTC | | OTC | OTC |
| FDA product code | | NUH, NGX, IRT | NUH, NGX, |
| Power Source(s) | | Battery powered, d.c.
3.7 V, 1 × built-in rechargeable lithium-ion battery | Battery powered, d.c.
3.7 V, 1 × built-in rechargeable lithium-ion battery |
| Method of Line Current
Isolation | | N/A
(internal power source) | N/A
(internal power source) |
| Patient Leakage Current | Normal condition (μΑ) | 6.0 | 50 |
| | Single fault condition (µA) | 5.6 | 70 |
| Number of Output Modes | | TENS: 15
EMS: 35
SH: 1 | TENS:12
EMS:12 |
| Number of output
Channels | Synchronous or
Alternating? | 2 Synchronous | 2 Synchronous |
| | Method of Channel
Isolation | By electrical circuit and software | By electrical circuit and software |
| Regulated Current or Regulated Voltage? | | Regulated current | Regulated current |
| Software/Firmware/Microprocessor Control? | | Yes | Yes |
| Automatic Overload Trip? | | Yes | Yes |
| Automatic No Load Trip? | | Yes | Yes |
| Automatic Shut Off? | | Yes | Yes |
| Patient Override Control? | | Yes | Yes |
| Indicator Display | On/Off Status? | Yes | Yes |
| | Low Battery? | Yes | Yes |
| | Voltage/Current Level? | Yes | Yes |
| Timer Range (minute) | | 5 to 100 minutes adjustable | 10 to 60 minutes adjustable |
| Compliant with Voluntary
Standards? | | ES60601-1 | ES60601-1 |
| | | IEC 60601-1-2 | IEC 60601-1-2 |
| | | IEC 60601-1-11 | IEC 60601-1-11 |
| | | IEC 60601-2-10 | IEC 60601-2-10 |
| Compliant with 21 CFR 898? | | Yes | Yes |
| Weight (g) | | Approx. 125
(including belt clip and battery) | Approx.65 |
| Dimensions (mm) [W × H × D] | | Approx.
139 × 66 × 26 (including belt clip) | Approx.
147.755.918.8 |
| Housing Materials and
Construction | | Plastic (ABS) enclosure | Plastic (ABS) enclosure |
| Waveform | | Biphasic | Biphasic |
| Shape | | Rectangular | Rectangular |
| Maximum Output
Voltage (Vp-p, ±10%) | @ 500Ω | 100 | 70 |
| | @ 2 kΩ | 180 | 150 |
| | @ 10 kΩ | 250 | 176 |
| Maximum Output
Current (mAp-p, ±10%) | @ 500Ω | 200 | 170 |
| | @ 2 kΩ | 90 | 75 |
| | @ 10 kΩ | 25 | 17.6 |
| Pulse Width (μs) | | 50 to 450 | 80 to 300 |
| Frequency (Hz) | | 1 to 150 | 1 to 150 |
| For interferential modes only: | | N/A | N/A |
| Beat Frequency (Hz) | | N/A | N/A |
| For multiphasic
waveforms
only: | Symmetrical
phases? | N/A | NA |
| | Phase
Duration | N/A | NA |
| Net Charge
(µC per pulse @ 500Ω) | | 0 | 0 |
| Maximum Phase Charge | | N/A | 12.6 |
| | | | |
| (μC @ 500Ω) | 45 | | |
| Maximum Average Current | | | |
| (mA @ 500Ω) | 13.5 | 9.39 | |
| Electrode Conductive
Surface Area (cm2) | 20.25 | 25 | |
| Maximum Current Density | | | |
| (mA/cm2 @ 500Ω) | 0.667 | 0.063 | |
| Maximum Power Density | | | |
| (W/cm2 @ 500Ω) | 0.0046 | 0.00294 | |
| | TENS: Level 0 to 50
EMS: Level 0 to 50
SH: Level LOW and HI | TENS: Level 0 to 40
EMS: Level 0 to 40 | |
| Output Intensity | | | |
| Heating Level (°C) | Level LOW: up to 41
Level HI: up to 43 | Level E1:up to 37
Level E2:up to 41
Level E3:up to 43 | |
| Operating Condition | Temperature: 5°C to 40°C
Humidity: 15% RH to 90% RH | Temperature: 5°C 40°C85 % RH | |
Humidity: 30 % RH
| Storage Condition | Temperature: 0°C to 40°C
Humidity: 0% RH to 90% RH | Temperature: -10°C 50°C90% RH | |
Humidity: 15% RH
| Use Altitude Limit (m) | 3000 | 3000 | |
| Use Atmospheric Pressure (hPa) | 700 to 1060 | 70 kPa~106 kPa | |
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Image /page/7/Picture/0 description: The image shows the logo for FAMIDOC. The logo is in gray and consists of the word "FAMIDOC" in a sans-serif font. There is a plus sign inside of the letter "O". The registered trademark symbol is in the upper right corner of the logo. Below the logo is the phrase "CARING FOR YOUR FAMILY" in a smaller sans-serif font.
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Image /page/8/Picture/1 description: The image shows the logo for FAMIDOC. The logo is in gray and consists of the word "FAMIDOC" in large, bold letters. Below the logo is the tagline "CARING FOR YOUR FAMILY" in smaller letters.
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Image /page/9/Picture/1 description: The image shows the logo for FAMIDOC. The logo is in a sans-serif font and is all uppercase. The "O" in DOC is replaced with a plus sign. There is a registered trademark symbol in the upper right corner of the logo. Below the logo is the tagline "CARING FOR YOUR FAMILY".
Similarity and Difference
Based on the comparison in our submission, we can determine that the subject device is almost identical to the predicate device in all aspect, except for removal of the SH finction. On the cther hand, the same intended use and provides the same functions by the same operating principle as the predicate device #1. Although there are still several specifications different between and predicate device has undergone and passed a series of safety tests complied with the specific FDA-recognized conserate these differences would not adversely impact the safety and effectiveness of the subject device. The differences between the subject device and the predicate device are not expected to adversely impact the safety and effectiveress of the subject device.
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Image /page/10/Picture/0 description: The image shows the logo for FAMIDOC. The logo consists of the word "FAMIDOC" in a sans-serif font, with a plus sign inside a circle in place of the "+" symbol. Below the logo is the tagline "CARING FOR YOUR FAMILY" in a smaller sans-serif font. The logo is simple and modern, and the tagline conveys the company's mission.
7. Performance Testing:
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
7.1 Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
7.2 Biocompatibility testing
The biocompatibility evaluation for the Heat StimPlus(Model:FDES115) conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
7.3 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Heat StimPlus(Model:FDES115), consisting of all the modules and accessories in the system complies with the IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral Standard:Electromagnetic disturbances – Requirements and tests standard for EMC.
7.4 Bench Testing
Bench testing was conducted on the Heat StimPlus(Model:FDES115) ,consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2015 MEDICAL ELECTRICAL EQUIPMENT -Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, And IEC 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (Edition 2.1 2016-04)
7.5 Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
7.6 Usability Testing
Usability testing according to following FDA Guidance 1757, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, was conducted.
7.7 Clinical data:
No clinical testing was performed
7.7 Summary
Based on the non-clinical and clinical performance as documented in the device devices devices were found to have a safety and effectiveness profile that is similar to the predicate device.
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8. Conclusions:
The proposed device has the same intended use and similar characteristics as the predicate device, Meanwhile, performance testing, bench testing, and safety report documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.
Famidoc maintains that the FDES115 is substantially equivalent to the predicate devices in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.