Heat StimPlus
Device Facts
| Record ID | K212918 |
|---|---|
| Device Name | Heat StimPlus |
| Applicant | Famidoc Technology Co., Ltd. |
| Product Code | NUH · Neurology |
| Decision Date | Dec 13, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications 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.
Device Story
Heat StimPlus (FDES115) is a battery-operated OTC transcutaneous electrical nerve stimulator (TENS) and powered muscle stimulator (EMS) with integrated heat function. Device delivers electrical stimulation via self-adhesive electrode pads; resistive elements in pads provide heat. TENS/EMS and heat are applied separately or in alternating combinations, never simultaneously. Device features two independent output channels; user selects from pre-set or custom programs. Used in home environment by adult patients. Output intensity, pulse width, and frequency are controlled by internal software. Healthcare providers/patients use device to manage muscle pain and improve muscle performance. Benefits include pain relief, muscle relaxation, and revitalization. Device charges via external power supply; no connectivity to other devices.
Clinical Evidence
No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) testing.
Technological Characteristics
ABS plastic enclosure; battery-powered (3.7V Li-ion); biphasic rectangular waveform; 2 output channels. Complies with AAMI/ANSI/ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10. Software-controlled stimulation parameters. Sterilization: Not applicable.
Indications for Use
Indicated for adults for temporary relief of pain associated with sore/aching muscles in shoulder, waist, back, arms, and legs due to exercise or household work (TENS) and for stimulation of healthy muscles to improve/facilitate muscle performance (EMS).
Regulatory Classification
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.
Predicate Devices
- HIVOX OTC Electrical Stimulator EM59-2 (K203574)
Submission Summary (Full Text)
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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
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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) | |
|---------------------------------------------------------------------------------|--|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <input checked="" type="checkbox"/> 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,<br>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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Image /page/5/Picture/0 description: The image shows the logo for FAMIDOC. The logo is in gray and consists of the word "FAMIDOC" in large, bold letters. A plus sign is in the middle of the word. Below the word "FAMIDOC" is the phrase "CARING FOR YOUR FAMILY" in smaller letters.
| 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<br>temporary relief of pain associated with sore and<br>aching muscles in the shoulder, waist, back, upper<br>extremities (arm)<br>and lower extremities (leg) due to strain from<br>exercise or normal household work activities.<br><br>EMS: This function is designed to be used for<br>stimulating healthy muscles in order to improve and<br>facilitate muscle performance.<br>SH: This function is designed to be used for<br>temporary relief of minor aches and pains. | TENS: This function is designed to be used for<br>temporary relief of pain associated with sore and<br>aching muscles in the shoulder, waist, back, upper<br>extremities (arm)<br>and lower extremities (leg) due to strain from<br>exercise or normal household work activities.<br><br>EMS: This function is designed to be used for<br>stimulating healthy muscles in order to improve and<br>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<br>Setting | | 43°C | 43°C |
| Maximum<br>Output Voltage<br>(Vp, ±20%) | @ 500 Ω | 50.0 | 35 |
| | @ 2 kΩ | 90.0 | 75 |
| | @ 10 kΩ | 125 | 88 |
| Maximum<br>Output Current<br>(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<br>(μC @ 500Ω) | | 45 | 12.6 |
| Maximum Current Density<br>(mA/cm2 @ 500Ω) | | 0.667 | 0.63 |
| Maximum Power Density<br>(W/cm2 @ 500Ω) | | 0.0046 | 0.00294 |
| Output Patterns | | Electrical stimulation only<br>Heat only<br>Electrical stimulation+ Heat simultaneously | Electrical stimulation only<br>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<br>temporary relief of pain associated with sore and<br>aching muscles in the shoulder, waist, back, upper<br>extremities (arm) and lower extremities (leg) due to<br>strain from exercise or normal household work<br>activities.<br><br>EMS: This function is designed to be used for<br>stimulating healthy muscles in order to improve and<br>facilitate muscle performance.<br><br>SH: This function is designed to be used for<br>temporary relief of minor aches and pains. | TENS: This function is designed to be used for<br>temporary relief of pain associated with sore and<br>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.<br>3.7 V, 1 × built-in rechargeable lithium-ion battery | Battery powered, d.c.<br>3.7 V, 1 × built-in rechargeable lithium-ion battery |
| Method of Line Current<br>Isolation | | N/A<br>(internal power source) | N/A<br>(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<br>EMS: 35<br>SH: 1 | TENS:12<br>EMS:12 |
| Number of output<br>Channels | Synchronous or<br>Alternating? | 2 Synchronous | 2 Synchronous |
| | Method of Channel<br>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<br>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<br>(including belt clip and battery) | Approx.65 |
| Dimensions (mm) [W × H × D] | | Approx.<br>139 × 66 × 26 (including belt clip) | Approx.<br>147.7*55.9*18.8 |
| Housing Materials and<br>Construction | | Plastic (ABS) enclosure | Plastic (ABS) enclosure |
| Waveform | | Biphasic | Biphasic |
| Shape | | Rectangular | Rectangular |
| Maximum Output<br>Voltage (Vp-p, ±10%) | @ 500Ω | 100 | 70 |
| | @ 2 kΩ | 180 | 150 |
| | @ 10 kΩ | 250 | 176 |
| Maximum Output<br>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…
