(87 days)
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.
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).
I am sorry, but the provided text does not contain the specific information required to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the StimPad OTC device, which primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory purposes.
Here's a breakdown of what's missing:
- Acceptance Criteria Table: There is no explicit table of acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for the device itself. The document focuses on comparing electrical and physical parameters to predicate devices.
- Reported Device Performance: While there are output specifications and compliance with safety standards, there are no reported performance metrics against specific clinical or technical acceptance criteria.
- Study Details for Performance: The document mentions a "formal usability evaluation study" to confirm appropriateness for OTC use. However, it does not provide details like:
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts.
- Adjudication method.
- Whether it was a MRMC study or a standalone study.
- Type of ground truth used.
- Sample size for the training set (if applicable for a usability study).
- How ground truth for the training set was established.
The document mainly discusses the technical characteristics and safety compliance of the StimPad OTC in comparison to its predicate devices to establish substantial equivalence. It highlights that 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."
Therefore, while a usability study was conducted, the detailed information about its methodology and results, as requested in your prompt, is not present in this document.
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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
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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
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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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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
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| 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 stimulatorfor pain relief intended for Over theCounter 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 useProduct Code: GZJ (21 CFR 882.5890) |
|---|---|
| Hi-Dow International, Inc Powered Muscle Stimulator | Cleared via K102598 for over the counter useProduct 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
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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.
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- 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 UseStimPad® | Hi-Dow JQ-5C |
|---|---|---|---|
| 510(k) Number | K142686 | K071120 | K102598 |
| Device Name and Model | StimPad® OTC Model #012011 | StimPad® Model021999 | # Power Muscle StimulatorModel #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 Lithiumbattery |
| Battery rechargeable | No | No | Yes |
| Number of batteries | 1 | 1 | 1 |
| Battery size (mm) | Diameter=20Height=3.2 | Diameter=20Height=3.2 | |
| Average DC current throughelectrodes when device is on but nopulses are being applied (µA) | ≤10 | ≤10 | 0 |
| Number of Output Modes | 3 | 3 | 6 |
| Number of Output Channels: | 1 | 1 | 2 |
| Regulated Current or RegulatedVoltage | Current | Current | Voltage |
Table 1 Basic unit characteristics
Stimpad® OTC TENS 510(k)
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| 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 | PrescriptionUseStimPad® | 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 multiphasicwaveforms only: | Symmetrical phases? | No | No | No |
| Net Charge per pulse (µC) at 500 Ω (If zero, statemethod of achieving zero net charge) | 40.9 | 40.9 | 0,balancedwaveform | |
| 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 |
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| Parameter | StimPad®OTC | PrescriptionUseStimPad® | Hi-Dow JQ-5C | |
|---|---|---|---|---|
| Maximum Average Power Density, (W/cm²) at 500 Ω(W/cm²), (using smallest electrode conductive surfacearea) | 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) secondstimulations onLow and 250+four(4) secondstimulations onHigh | Minimum of 500+four (4) secondstimulations onLow and 250+four(4) secondstimulations onHigh | N/A | |
| (d) Duty Cycle: Line (b) x Line(c) | 2000- Low1000-High | 2000- Low1000-High | N/A | |
| ON time (seconds) | 4 | 4 | 5 (M2, M3 and M4) | |
| OFF time (seconds) | Thedeviceremains off untilthe top isdepressedagainst the skin | Thedeviceremains off untilthe top isdepressedagainst 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 22cm foil zip lock pouch | Packaged in a 13.5 cm x 22cm foil zip lock pouch | Box packaging with JC-QC unit, 1 set of small single sided adhesiveelectrode pad, large single sided adhesivepads, XL single sided adhesive electrode pads,2 electrode wire, AC/DC adaptor, applicationacupoints chart and pad holder |
| Biocompatibility | The main user contactmaterials are hydrogel disks | The main user contactmaterials are hydrogel disks | Biological safetyconformity 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 |
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SECTION 5
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| Parameter | StimPad® | ||
|---|---|---|---|
| OTC | Prescription Use | Hi-Dow JQ-5C | |
| and the standard IEC 60601-1-2:2007 "Medical electricalequipment Part 2. CollateralStandard: Electromagneticcompatibility" wereperformed. | and the standard IEC 60601-1-2:2007 "Medical electricalequipment Part 2. CollateralStandard: Electromagneticcompatibility" wereperformed. | ||
| • The microcoulombsobserved at all settings donot raise any safetyconcerns | • The microcoulombsobserved at all settings donot raise any safetyconcerns | ||
| • Leaking current testingrequirements fulfilled | • Leaking current testingrequirements fulfilled | ||
| • All of the following passedevaluation: MarkingDurability, EnclosureMechanical Strength, DropImpact, Temperature,Leakage Current,Dielectric VoltageWithstand, Humidity,Cleaning, Mold StressRelief, Abnormal | • All of the following passedevaluation: MarkingDurability, EnclosureMechanical Strength, DropImpact, Temperature,Leakage Current,Dielectric VoltageWithstand, Humidity,Cleaning, Mold StressRelief, Abnormal | ||
| • Device conforms to FCCClass B requirements | • Device conforms to FCCClass B requirements | ||
| • EMC evaluations fulfilledrequirements | • EMC evaluations fulfilledrequirements | ||
| BenchTesting | Evaluations of the electricalsignal delivered and theconductive media performed. | Evaluations of the electricalsignal delivered and theconductive media performed. | Presumed benchperformance testingperformed as the device is510k approved |
| Replacement of electrodesafter 20 four secondstimulations recommended | Replacement of electrodesafter 20 four secondstimulations 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
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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.
§ 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).