(87 days)
No
The device description details pre-programmed settings for frequency, pulse width, and duration, with no mention of adaptive learning or data-driven decision-making. The performance studies focus on electrical safety, electromagnetic compatibility, and usability, not on the performance of an AI/ML algorithm. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended for the relief of pain associated with sore or aching muscles, which directly addresses a medical condition, classifying it as therapeutic.
No
The device description and intended use clearly state that the StimPad OTC is a "nerve stimulation therapy device" indicated for "relief of pain," which are therapeutic rather than diagnostic functions. Its purpose is to deliver electrical stimulation, not to identify or measure health conditions.
No
The device description explicitly details hardware components such as electrodes, electronic components, and a battery, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the relief of pain associated with sore or aching muscles. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device description details a nerve stimulation therapy device that applies electrical stimulation to the body. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a person's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The StimPad OTC is indicated for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household work activities.
Product codes
NUH
Device Description
The StimPad® OTC is a non-invasive nerve stimulation therapy device that can be placed directly at the site of pain for direct electrical stimulation.
Stimulation is achieved through self-contained electrodes that are snap fit connected to the electronic components. There are no separate wires or electrode pads. The StimPad® OTC is powered by a replaceable, 3 volt Lithium battery (CR2032).
The StimPad™ device has pre-programmed settings for frequency (ie, 7.1 Hz), pulse width (ie, 47 milliseconds for the low, medium and high intensity settings at 500 ohms, 2000 ohms, and 10,000 ohms) and the timed setting for treatment duration (4 seconds or less). The treatment duration is limited to four seconds or less of stimulation per application/treatment, and the user is prevented from modifying this setting. The intensity levels can be adjusted between low (stimulation is usually imperceptible), medium (usually the most comfortable), and high (maximum level for comfort).
The shelf life of the StimPad® OTC is dictated by the shelf life of the electrodes used in its manufacture. These components have a shelf life of 18 months and each lot is labeled with a "use before date" by the supplier. This date is assigned to the lot of StimPad® OTC devices in which they are used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back, arms, or legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the Counter Use (21 CFR 801 Subpart C)
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
Development and testing identified in this submission were actually performed on the prescription use StimPad® (K071120 refers). Results and conclusions of the prevailing development tests are applicable to the OTC variant of the device. Electrical safety and electromagnetic compatibility properties demonstrated by formal test confirm StimPad® OTC remains in compliance with the requirements of AAMI ANSI 60601-1:2005 and AAMI ANSI IEC 60601-1-2:2009 standards, respectively. Therefore, evidence of tests against the standards supports the claim and demonstrates that the StimPad® OTC device is substantially equivalent to the prescription use StimPad®. Other than cosmetic label changes and the extension of the device intended purpose to encompass OTC use, no other changes in specification of a significant nature have been introduced. Therefore, prevailing design qualification tests to characterize and assure consistent electrical output performance as well as successfully performed software validation testing activities remain current and valid, thereby assuring comparability to the prescription use StimPad®. Furthermore, performance of the usability evaluation study confirmed that StimPad® OTC is appropriate for over the counter use.
Key Metrics
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 U.S. Department of Health & Human Services. 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 three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Aemed, Inc. c/o Rachid Hattab Quality First International Suites 317/318 Burford Business Centre 11 Burford Rd. Stratford, London, E15 2ST United Kingdom
Re: K142686
Trade/Device Name: StimPad OTC Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: August 21, 2014 Received: September 22, 2014
Dear Mr. Hattab:
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
1
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 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/Resourcesfor You/Industry/default.htm. 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 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.
Felipe Aquel -S
Carlos L. Peña, Ph.D., M.S. for 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) K142686
Device Name StimPad OTC
Indications for Use (Describe)
The StimPad OTC is indicated for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household work activities.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image is a logo for a product called "StimPAD TENS". The word "StimPAD" is written in a stylized, blue font with a white outline. The letters are slightly curved and have a three-dimensional effect. Below "StimPAD" is the word "TENS" in a bold, black font. The overall design is simple and clean, with a focus on the product name.
510(k) Summary
As required by 21 CFR 807.87(h) and 807.92
Date Prepared: 16 September 2014
A. 510(k) OWNER / SUBMITTER
Name:
AEMED, Inc
Address:
4 Turtle Grove Lane Village of Golf Florida 33436 United States of America
B. CONTACT INFORMATION
Rachid Hattab Name: Quality First International Suites 317/318 Burford Business Centre 11 Burford Road Stratford Address: London E15 2ST United Kingdom
4
| Telephone Number: | + 44 208 221 23 61 |
|---|---|
| Fax Number: | + 44 208 221 19 12 |
| e-mail Address: | rachid@qualityfirstint.com |
C. DEVICE
| Trade name or Proprietary name: | AEMED StimPad® OTC (Model #012011) |
|---|---|
| Common Name: | TENS Device for OTC Use |
| Classification Name: | Transcutaneous electrical nerve stimulator |
| for pain relief intended for Over the | |
| Counter Use | |
| Classification: | II |
| Regulation / Product Code: | 21 CFR 882.5890 / NUH |
D. LEGALLY MARKETED PEDICATE DEVICES
| AEMED, Inc. StimPad® TENS | Cleared via K071120 for prescription use
Product Code: GZJ (21 CFR 882.5890) |
|-----------------------------------------------------|---------------------------------------------------------------------------------------|
| Hi-Dow International, Inc Powered Muscle Stimulator | Cleared via K102598 for over the counter use
Product Code: JQ-5C (21 CFR 882.5890) |
E. INTENDED USE
The StimPad® OTC is a transcutaneous electrical nerve stimulator (TENS) device intended to deliver electrical stimulation applied through the surface of a user's skin to relieve pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. The StimPad® OTC is an over the counter device to be used for selftreatment.
F. INDICATIONS FOR USE
SECTION 5
5
The StimPad® OTC is indicated for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
G. DEVICE DESCRIPTION
The StimPad® OTC is a non-invasive nerve stimulation therapy device that can be placed directly at the site of pain for direct electrical stimulation.
Stimulation is achieved through self-contained electrodes that are snap fit connected to the electronic components. There are no separate wires or electrode pads. The StimPad® OTC is powered by a replaceable, 3 volt Lithium battery (CR2032).
The StimPad™ device has pre-programmed settings for frequency (ie, 7.1 Hz), pulse width (ie, 47 milliseconds for the low, medium and high intensity settings at 500 ohms, 2000 ohms, and 10,000 ohms) and the timed setting for treatment duration (4 seconds or less). The treatment duration is limited to four seconds or less of stimulation per application/treatment, and the user is prevented from modifying this setting. The intensity levels can be adjusted between low (stimulation is usually imperceptible), medium (usually the most comfortable), and high (maximum level for comfort).
The shelf life of the StimPad® OTC is dictated by the shelf life of the electrodes used in its manufacture. These components have a shelf life of 18 months and each lot is labeled with a "use before date" by the supplier. This date is assigned to the lot of StimPad® OTC devices in which they are used.
OF TECHNOLOGICAL H. SUMMARY CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The StimPad® OTC is substantially equivalent to the predicate devices for the following reasons:
- The StimPad® OTC also uses the same technology and operating principles as ● the predicate devices. Both the StimPad® OTC and predicate devices are portable hand held battery operated micro current devices that delivers electrical current by means of a direct contact point for the purpose of alleviating or relief of pain.
- . The design features of StimPad® OTC are comparable to the predicate devices. The user controls and displays are operated in a comparable manner by the user, and the operating modes are analogous.
6
- The StimPad® OTC and StimPad® have different indications for use and ● intended user populations since the former is an over the counter use device and the latter is a prescription use device. Empirical proof of substantial equivalence was not necessary in this instance since the difference between the devices is simply that StimPad® OTC is available for OTC use rather than prescription by medical practitioner. Adequacy of the StimPad® OTC for OTC use was determined by formal usability evaluation study. The study confirms that StimPad® OTC is appropriate for over the counter use.
- . The StimPad® OTC and Hi-Dow International, Inc Powered Muscle Stimulator have similar indications for use and intended user populations. Both devices are indicated for the relief of pain associated with sore or aching muscles of the lower back, arms or legs due to strain from exercises or normal household and work activities. Both devices are intended for over the counter use.
Tables 1, 2 and 3 compares basic unit characteristics, output specifications and physical equivalence between the AEMED StimPad® OTC, AEMED prescription use StimPad® device and HI-Dow JQ-5C.
| Parameter | StimPad® OTC | Prescription Use
StimPad® | Hi-Dow JQ-5C |
|----------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------|-------------------------------------------|
| 510(k) Number | K142686 | K071120 | K102598 |
| Device Name and Model | StimPad® OTC Model #
012011 | StimPad® Model
021999 | # Power Muscle Stimulator
Model #JQ-5C |
| Manufacturer | AEMED, Inc | AEMED, Inc | Hi-Dow International, Inc |
| Device Class | II | II | II |
| Classification Panel | Neurology | Neurology | Neurology |
| Power Source(s) | 3 volt Lithium battery
(CR2032) | 3 volt Lithium battery
(CR2032) | 3.75 volt DC Lithium
battery |
| Battery rechargeable | No | No | Yes |
| Number of batteries | 1 | 1 | 1 |
| Battery size (mm) | Diameter=20
Height=3.2 | Diameter=20
Height=3.2 | |
| Average DC current through
electrodes when device is on but no
pulses are being applied (µA) | ≤10 | ≤10 | 0 |
| Number of Output Modes | 3 | 3 | 6 |
| Number of Output Channels: | 1 | 1 | 2 |
| Regulated Current or Regulated
Voltage | Current | Current | Voltage |
Table 1 Basic unit characteristics
Stimpad® OTC TENS 510(k)
7
| Parameter | StimPad® OTC | Prescription Use StimPad® | Hi-Dow JQ-5C |
|---|---|---|---|
| Software/Firmware/Microprocessor Control | Yes | Yes | Yes |
| Automatic Shut Off | Yes | Yes | Yes |
| Indicator Display: On/Off Status | Yes | Yes | Yes |
| Low Battery | Yes | Yes | Yes |
| Timer Range (minutes) | Single 4 second pulse or multiple pulses via manual mode (e.g. 10 deliveries or 40 seconds) | Single 4 second pulse or multiple pulses via manual mode (e.g. 10 deliveries or 40 seconds) | Timer can be adjusted after selecting one of the 6 modes |
| Compliance with Voluntary Standards | Yes | Yes | Yes |
| Weight (gram) | 95 | 95 | 200 |
| Dimensions (mm) [W x H x D] | 120 X 73 X 35 | 120 X 73 X 35 | 114 x 71 x 10 |
| Housing Materials and Construction | Polycarbonate | Polycarbonate | ABS |
| Portable | Yes | Yes | Yes |
| User friendly | Yes | Yes | Yes |
Table 2 Output Specifications
| Parameter | StimPad®
OTC | Prescription
Use
StimPad® | Hi-Dow JQ-5C | |
|--------------------------------------------------------------------------------------------|-----------------------|---------------------------------|----------------------------|----|
| Waveform (e.g., pulsed monophasic, biphasic) | Pulsed,
Monophasic | Pulsed,
Monophasic | Pulsed, Monophasic | |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Rectangular | Rectangular | |
| Maximum output voltage (volts) (+/- 10%) | 122.50@500Ω | 122.50@500Ω | 62.4@ 500 | |
| | 159.00@2 kΩ | 159.00@2 kΩ | 79.2@2.2K | |
| | 159.99@10 kΩ | 159.99@10 kΩ | 84@10K | |
| Maximum output current (mA) (+/- 10%) | 0.25@500Ω | 0.25@500Ω | 124.8@500 | |
| | 0.08@ 2 kΩ | 0.08@ 2 kΩ | 39.6@2.2K | |
| | 0.02@10 kΩ | 0.02@10 kΩ | 8.4@10K | |
| Duration of primary (depolarizing) phase (ms) | 92 | 92 | N/A | |
| Pulse duration (µsec) | 222-264 | 222-264 | 16300~781000 | |
| Frequency (Hz) | 7.1 | 7.1 | 61.3 | |
| For multiphasic
waveforms only: | Symmetrical phases? | No | No | No |
| Net Charge per pulse (µC) at 500 Ω (If zero, state
method of achieving zero net charge) | 40.9 | 40.9 | 0,
balanced
waveform | |
| Maximum Phase Charge (µC) at 500 Ω | 12.066 | 12.066 | 17.92 | |
| Maximum Current Density (mA/cm²) at 500 Ω | 12.066 | 12.066 | 9.92 | |
| Maximum Average Current (mA) at 500 Ω | 0.25 | 0.25 | N/A | |
8
| | Parameter | StimPad®
OTC | Prescription
Use
StimPad® | Hi-Dow JQ-5C |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------|
| | Maximum Average Power Density, (W/cm²) at 500 Ω
(W/cm²), (using smallest electrode conductive surface
area) | 0.06033 | 0.06033 | 2.72 |
| Burst mode
(i.e., pulse trains): | (a) Pulses per burst | 29 | 29 | N/A |
| | (b) Bursts per second | 4 | 4 | N/A |
| | (c) Burst duration (sec) | Minimum of 500+
four (4) second
stimulations on
Low and 250+
four(4) second
stimulations on
High | Minimum of 500+
four (4) second
stimulations on
Low and 250+
four(4) second
stimulations on
High | N/A |
| | (d) Duty Cycle: Line (b) x Line
(c) | 2000- Low
1000-High | 2000- Low
1000-High | N/A |
| ON time (seconds) | | 4 | 4 | 5 (M2, M3 and M4) |
| OFF time (seconds) | | The
device
remains off until
the top is
depressed
against the skin | The
device
remains off until
the top is
depressed
against the skin | 3 (M2)
2 (M3 and M4) |
Table 3 Overview of selected properties
| Parameter | StimPad® OTC | StimPad® Prescription Use | Hi-Dow JQ-5C |
|---|---|---|---|
| 510(k) Number | K142686 | K071120 | K102598 |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Packaging | Packaged in a 13.5 cm x 22 | ||
| cm foil zip lock pouch | Packaged in a 13.5 cm x 22 | ||
| cm foil zip lock pouch | Box packaging with JC- | ||
| QC unit, 1 set of small single sided adhesive | |||
| electrode pad, large single sided adhesive | |||
| pads, XL single sided adhesive electrode pads, | |||
| 2 electrode wire, AC/DC adaptor, application | |||
| acupoints chart and pad holder | |||
| Biocompatibility | The main user contact | ||
| materials are hydrogel disks | The main user contact | ||
| materials are hydrogel disks | Biological safety | ||
| conformity compliance | |||
| Parameter | OTC | Prescription Use | Hi-Dow JQ-5C |
| and polycarbonate housing material with a limited contact duration (i.e., less than 24 hours). Both items are biocompatible | and polycarbonate housing material with a limited contact duration (i.e., less than 24 hours). Both items are biocompatible | performed according to EN ISO 10993-1:2009 | |
| Evaluations per ANSI/AAMI/ISO 10993-1:2009. “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing” and the FDA Blue Book Memorandum # G95-1 regarding biocompatibility, were performed | Evaluations per ANSI/AAMI/ISO 10993-1:2009. “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing” and the FDA Blue Book Memorandum # G95-1 regarding biocompatibility, were performed | ||
| Software | The device contains a software controlled microprocessor. | The device contains a software controlled microprocessor. | The device contains a software controlled microprocessor. |
| Evaluations per the “Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices” (issued May 11, 2005), were performed. The level of concern considered minorNo failure modes and associated potential hazards that could occur with the device are software related | Evaluations per the “Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices” (issued May 11, 2005), were performed. The level of concern considered minorNo failure modes and associated potential hazards that could occur with the device are software related | Presumed software conformity for software contained in medical devices as device is 510k approved | |
| Electrical Safety and Electromagnetic Compatibility | Evaluations per UL® 2601-1 and CSA 22.2 No. 601.1M90 were performed U.S. Federal Communication Commission (FCC) Code of Federal Regulations (CFR), Title 47 – Telecommunication, Part 15 – Radio Frequency Devices, Part B – Unintentional Radiators. Section 15.109(b) Radiated | Evaluations per UL® 2601-1 and CSA 22.2 No. 601.1M90 were performed U.S. Federal Communication Commission (FCC) Code of Federal Regulations (CFR), Title 47 – Telecommunication, Part 15 – Radio Frequency Devices, Part B – Unintentional Radiators. Section 15.109(b) Radiated | Compliance claimed with EN 60601-1, EN 60601-1-2, EN ISO 14971:2009, EN 60601-2-10:2000 + A1:2001 |
9
SECTION 5
10
| Parameter | StimPad® | ||
|---|---|---|---|
| OTC | Prescription Use | Hi-Dow JQ-5C | |
| and the standard IEC 60601- | |||
| 1-2:2007 "Medical electrical | |||
| equipment Part 2. Collateral | |||
| Standard: Electromagnetic | |||
| compatibility" were | |||
| performed. | and the standard IEC 60601- | ||
| 1-2:2007 "Medical electrical | |||
| equipment Part 2. Collateral | |||
| Standard: Electromagnetic | |||
| compatibility" were | |||
| performed. | |||
| • The microcoulombs | |||
| observed at all settings do | |||
| not raise any safety | |||
| concerns | • The microcoulombs | ||
| observed at all settings do | |||
| not raise any safety | |||
| concerns | |||
| • Leaking current testing | |||
| requirements fulfilled | • Leaking current testing | ||
| requirements fulfilled | |||
| • All of the following passed | |||
| evaluation: Marking | |||
| Durability, Enclosure | |||
| Mechanical Strength, Drop | |||
| Impact, Temperature, | |||
| Leakage Current, | |||
| Dielectric Voltage | |||
| Withstand, Humidity, | |||
| Cleaning, Mold Stress | |||
| Relief, Abnormal | • All of the following passed | ||
| evaluation: Marking | |||
| Durability, Enclosure | |||
| Mechanical Strength, Drop | |||
| Impact, Temperature, | |||
| Leakage Current, | |||
| Dielectric Voltage | |||
| Withstand, Humidity, | |||
| Cleaning, Mold Stress | |||
| Relief, Abnormal | |||
| • Device conforms to FCC | |||
| Class B requirements | • Device conforms to FCC | ||
| Class B requirements | |||
| • EMC evaluations fulfilled | |||
| requirements | • EMC evaluations fulfilled | ||
| requirements | |||
| Bench | |||
| Testing | Evaluations of the electrical | ||
| signal delivered and the | |||
| conductive media performed. | Evaluations of the electrical | ||
| signal delivered and the | |||
| conductive media performed. | Presumed bench | ||
| performance testing | |||
| performed as the device is | |||
| 510k approved | |||
| Replacement of electrodes | |||
| after 20 four second | |||
| stimulations recommended | Replacement of electrodes | ||
| after 20 four second | |||
| stimulations recommended |
SUMMARY OF TESTING PERFORMED -
Development and testing identified in this submission were actually performed on the prescription use StimPad® (K071120 refers). Results and conclusions of the prevailing development tests are applicable to the OTC variant of the device. Electrical safety and electromagnetic compatibility properties demonstrated by formal test confirm StimPad® OTC remains in compliance with the requirements of AAMI ANSI 60601-1:2005 and AAMI ANSI IEC 60601-1-2:2009 standards, respectively. Therefore, evidence of tests against the standards supports the
11
claim and demonstrates that the StimPad® OTC device is substantially equivalent to the prescription use StimPad®. Other than cosmetic label changes and the extension of the device intended purpose to encompass OTC use, no other changes in specification of a significant nature have been introduced. Therefore, prevailing design qualification tests to characterize and assure consistent electrical output performance as well as successfully performed software validation testing activities remain current and valid, thereby assuring comparability to the prescription use StimPad®. Furthermore, performance of the usability evaluation study confirmed that StimPad® OTC is appropriate for over the counter use.