(95 days)
Not Found
No
The document does not mention AI or ML, and the device description focuses on pre-set programs and user-adjustable intensity, which are typical features of traditional TENS/EMS devices.
Yes.
The device is designed for temporary relief of pain associated with sore and aching muscles and to stimulate muscles for improved performance, which are therapeutic applications.
No
The device is described as an OTC TENS/EMS stimulator designed for temporary pain relief and muscle stimulation, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components including a control unit, battery unit, electrodes, and an adapter, in addition to the software app.
Based on the provided information, 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 (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- PulseRelief Function: The PulseRelief device is a TENS/EMS stimulator. It works by applying electrical pulses to the skin to relieve pain and stimulate muscles. It does not analyze any biological specimens from the body.
- Intended Use: The intended use clearly states it's for temporary pain relief and muscle stimulation, not for diagnostic purposes based on in vitro analysis.
- Device Description: The description details the electrical stimulation mechanism and components, none of which involve the analysis of biological samples.
Therefore, the PulseRelief device falls under the category of a physical therapy or pain management device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OTC TENS/EMS stimulator PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes
NUH, NGX
Device Description
PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities and can be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Pulse Relief is designed to be used at home, by adults of all genders
For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The device delivers pulses across the skin through these electrodes. This activates the underlying sensory nerves. The user can choose 15 pre-set TENS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.
For Electrical Muscle Stimulation (EMS). the electrodes are placed near the muscle to be stimulated. The device generates electrical pulses and passes these pulses across the surface of the skin to activate the underlying motor nerves. This makes the muscle contract. Contraction helps to condition the muscle in in order to facilitate performance
The PulseRelief system consists of the following elements:
- Control unit with cable: generates the TENS/EMS pulses; connects to the 1st electrode; . communicates with the mobile device; connects to the battery unit. The control unit has an on-off button.
- . Battery unit: contains a battery and charging circuit; connects the 200 electrode to the control unit.
- . Electrodes: Self-adhesive re-usable hydrogel electrodes with metal target plate for magnetic clamping to the control unit and battery unit.
- . App on mobile device. The app controls the functions of the PulseRelief device via a Bluetooth Low Energy connection between the mobile device and the PulseRelief device.
- Adapter: for charging the battery unit via a micro-USB socket. To connect the USB-cable . to the battery unit, the control unit needs to be disconnected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Home, by adults of all genders
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)
- Biocompatibility testing conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Tests included Cytotoxicity, Sensitization, and Irritation.
- Electrical safety and electromagnetic compatibility (EMC) testing complied with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62133, and FCC part 15 (Subpart B and C).
- Software Verification and Validation Testing conducted as recommended by FDA's Guidance for Industry and FDA Staff, with the software considered a "Moderate" level of concern. IEC 62304 was followed.
- Usability Testing conducted according to IEC 62366 and FDA Guidance 1757.
- Risk management followed ISO 14971:2007.
- Symbols used conform to ISO 15223-1:2012.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with flowing lines representing the body and head.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2015
Philips Consumer Lifestyle Marta Walker Senior Safety, Compliance & Regulatory Manager 1600 Summer Street Stamford, Connecticut 06905
Re: K151035
Trade/Device Name: Pulserelief Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: April 1, 2015 Received: June 25, 2015
Dear Marta Walker:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Michael J.Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151035
Device Name PulseRelief
Indications for Use (Describe)
The OTC TENS/EMS stimulator PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Type of Use (Select one or both, as applicable)
| ☐ | Experimental Use (Specific to 21 CFR 58.3(d) - Laboratory Research) |
|---|---|
| ☑ | Clinical Trial (Specific to 21 CFR 58.3(c) - Clinical Investigations) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92
1. SUBMITTER OF 510(K):
| Company name:
Registration number:
Address: | Philips Consumer Lifestyle
3009181561
1600 Summer Street
Stamford, CT 06905 USA | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--|
| Phone:
email
Correspondent: | +31 6 319 78 546
marta.walker@philips.com
Marta Walker,
Sr. Manager Safety, Compliance & Regulatory | |
| Date of Preparation: | July 16th, 2015 | |
2. DEVICE:
| Trade/Proprietary Name: | PulseRelief |
|---|---|
| Common/Usual Name: | TENS |
| Regulation Name | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Classification Name: | Neurological Therapeutic Devices |
| Classification: | 21CFR 882.5890 and 890.5850 Class II |
| Product Code: | NUH and NGX |
The PulseRelief device is to be used with the Philips Self-Adhesive Electrode (K151033).
3. PREDICATE DEVICE
Our new device is based on the legally marketed device cited in the table below:
Table 1: Predicate device
| Manufacturer | Device | 510(k) # | Product Code: |
|---|---|---|---|
| Shenzhen | |||
| Dongdixin | |||
| Technology | |||
| Co., Ltd. | OTC Electrical stimulator Models MT900I, LT3060 | K 130802 | NUH, NGX |
4
4. DEVICE DESCRIPTION
PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities and can be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Pulse Relief is designed to be used at home, by adults of all genders
For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The device delivers pulses across the skin through these electrodes. This activates the underlying sensory nerves. The user can choose 15 pre-set TENS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.
For Electrical Muscle Stimulation (EMS). the electrodes are placed near the muscle to be stimulated. The device generates electrical pulses and passes these pulses across the surface of the skin to activate the underlying motor nerves. This makes the muscle contract. Contraction helps to condition the muscle in in order to facilitate performance
The PulseRelief system consists of the following elements:
- Control unit with cable: generates the TENS/EMS pulses; connects to the 1st electrode; . communicates with the mobile device; connects to the battery unit. The control unit has an on-off button.
- . Battery unit: contains a battery and charging circuit; connects the 200 electrode to the control unit.
- . Electrodes: Self-adhesive re-usable hydrogel electrodes with metal target plate for magnetic clamping to the control unit and battery unit.
- . App on mobile device. The app controls the functions of the PulseRelief device via a Bluetooth Low Energy connection between the mobile device and the PulseRelief device.
- Adapter: for charging the battery unit via a micro-USB socket. To connect the USB-cable . to the battery unit, the control unit needs to be disconnected.
| Parameter | PulseRelief Specification | |
|---|---|---|
| Treatment modes | TENS | 15 programs |
| EMS | 5 programs | |
| Pulse Output parameters | Number of output channels | 1 |
| Current pulse shape | Biphase symmetrical | |
| Image: pulse shape | ||
| Frequency range | 1-100 Hz | |
| Pulse duration | 60-350 $\mu$ s | |
| Treatment duration | 1-59min or continuous | |
| General specifications | Power supply | DC 3.7V Li-ion |
| System IP Classification | IP22 | |
| Size | 53.5mm x 53.5mm x 11.5mm | |
| Weight | 62 grams |
Table 2: Main device parameters
5
| Parameter | PulseRelief Specification | |
|---|---|---|
| Operating conditions | Temperature | 5°C to 40°C (41°F to 104°F) |
| Operating conditions | Relative humidity | 15%-93% (non-condensing) |
| Operating conditions | Atmospheric pressure | 700 to 1060 hPa |
| Storage conditions | ||
| (device) | Temperature | -10°C to 50°C (14°F to 122°F) |
| Storage conditions | ||
| (device) | Relative humidity | less than 93% (non-condensing) |
| Storage conditions | ||
| (device) | Atmospheric pressure | 700 to 1060 hPa |
| Storage conditions | ||
| (electrodes) | Temperature | 0°C to 40°C (32°F to 104°F) |
| Storage conditions | ||
| (electrodes) | Relative humidity | less than 93% (non-condensing) |
| Storage conditions | ||
| (electrodes) | Atmospheric pressure | 700 to 1060 hPa |
| Adapter | Rated input | 100-240V / 150mA |
| Adapter | Rated frequency | 50-60 Hz |
| Adapter | Rated output | 5V DC / 300mA |
| Electrode | Dimensions | 50mm x 50mm (2.16in x 2.16in) (2pcs) |
The PulseRelief device is controlled by means of an app on a mobile device (phone or tablet). The communication is done via Bluetooth Low Energy. The app operates on IOS and Android platforms (IOS 7 and 8, Android 4.4 KitKat and higher).
Interface with the user
With the app, the user can do the following:
- Select a body part (optional); by selecting a body part, a list of suggested treatments is . provided
- Enter a pain score (optional) .
- . Select a treatment
- . Select the treatment duration (optional)
- . Start, pause and stop a treatment
- . Increment and decrement the intensity
- . Enter a post-treatment sensation score
- . Display the Treatment Diary
- . Display the Instructions for Use
- . Display the battery status of the PulseRelief device
- Clear the Treatment Diary on a PulsRelief device .
- Decouple with a PulseRelief device ("forget my device") .
Diary function
The app contains a Diary function that shows the details of over 200 past treatments. For each treatment, the information consists of treatment data and time, treatment duration, treatment intensity, body part (if selected by user), pain score and satisfaction score (if scored by the user). The Diary data is stored on the PulseRelief device. The mobile device retrieves the actual Diary data from the connected PulseRelief.
6
Interface with the PulseRelief device
The following functions are provided for communication between the PulseRelief device:
- Pair with a PulseRelief device .
- . Set or read the treatment program
- . Read the connection status of the electrodes
- Read the stimulation intensity .
- Set the treatment time ●
- . Read the remaining treatment time
- Increment the stimulation intensity ●
- . Decrement the stimulation intensity
- Set the stimulation intensity to zero .
- . Read the battery level of the PulseRelief device
- . Set or read the body part
- . Set or read the pain score
- . Set or read the Post-treatment sensation
- Read the Treatment Diary data, system data and event log data .
- Set the system time of the PulseRelief device .
- Read the system ID and unique device ID of the PulseRelief device .
- Read the firmware revision of the PulseRelief device .
- Factory reset of the PulseRelief device .
The controls and indicators of the PulseRelief device are listed in the Table below.
| Unit | Control/Indicator | User interface | Function |
|---|---|---|---|
| Control Unit | On-off button | Press button | |
| (when device is off) | Device on, such that mobile | ||
| device can connect | |||
| Press button | |||
| (when device is on) | Device off (at any time, before, | ||
| during or after treatment) | |||
| LED indicator | Off | Device is off | |
| Green continuous | Device is on, no signal output is | ||
| active | |||
| Yellow blinking (1Hz) | Device is on, signal output is | ||
| active | |||
| Green rapid blinking (2Hz) | Device is on and in connection | ||
| mode, no signal output is active | |||
| Battery Unit | LED indicator | Off | Device is not connected to |
| charger | |||
| Red continuous | Device is connected to a | ||
| charger, battery is charging | |||
| Green continuous | Device is connected to a | ||
| charger, battery is fully charged |
Table 3: PulseRelief device controls and indicators
7
5. INDICATION FOR USE:
5.1 PulseRelief
The OTC TENS/EMS stimulator PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
5.2 Predicate MT9001 OTC TENS/EMS stimulator
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
As demonstrated above, there are no differences in the intended use of the PulseRelief and the selected predicate, MT9001 OTC.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
6.1 Basic Unit Characteristics
Both the PulseRelief and Predicate Device utilise the application of electrical current through electrodes placed on the skin for pain control, or electrical muscle stimulation (EMS) the elicitation of muscle contraction using electric impulses. The impulses are generated by the device and delivered through electrodes on the skin in direct proximity to the (painful) muscles to be stimulated.
A comparison of the basic characteristics of the PulseRelief and that of the Predicate is shown in the Table below.
| Parameter | PulseRelief | Predicate Device |
|---|---|---|
| 510(k) Number | (to be assigned) | K130802 |
| Device Name and Model | PulseRelief | MT9001 OTC |
| TENS/EMS stimulator | ||
| Manufacturer | Philips Consumer | |
| Lifestyle | Shenzhen Dongdixin | |
| Technology Co., Ltd. | ||
| Regulation Number | 882.5890 | |
| 890.5850 | 882.5890 | |
| 890.5850 | ||
| Product Code | NUH | |
| NGX | NUH | |
| NGX | ||
| Power Source(s)† | Li-ion 3.7V 500mAh | 9V battery |
Table 4: Substantial Equivalence Comparison Table
8
| - Method of Line Current Isolation | N/A | N/A |
|---|---|---|
| - Patient Leakage Current†† |
- Normal Condition (µA) |