(258 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard muscle stimulation technology controlled by a mobile application.
No.
The "Intended Use / Indications for Use" section explicitly states that the device is "not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind."
No
The "Intended Use / Indications for Use" section explicitly states that the device is "not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind," which would include diagnosis.
No
The device description explicitly mentions a "PowerDot PD-01 Muscle Stimulator" which is a battery-powered neuromuscular stimulator and includes accessories like lead cables, a USB charging cable, and electrode pads. This indicates the device includes hardware components beyond just software.
Based on the provided information, the PowerDot PD-01 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "stimulation of healthy muscles in order to improve or facilitate muscle performance." It also explicitly states it's "not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind." IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a neuromuscular stimulator that applies electrical stimulation to muscles. This is an external physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information.
Therefore, the PowerDot PD-01 device falls under the category of a physical medicine device, specifically a muscle stimulator, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.
Product codes
NGX
Device Description
PowerDot PD-01 Muscle Stimulator is a battery-powered neuromuscular stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance and, with that regard, may be considered a technique or method for muscle training.
PowerDot PD-01 device is designed to be used together with PowerDot Mobile Application.
PowerDot PD-01 device uses Bluetooth™ Low Energy (Bluetooth 4.0, Class II) wireless radio frequency protocol for communication with supported range of mobile devices (such as smartphones and/or tablets) via PowerDot Mobile Application.
Accessories include lead cables of 2 different lengths, USB charging cable, 2 types of hydrogel-based self-adhesive electrode pads and carrying case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Electrodes can be applied to multiple anatomical sites.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter (non-prescriptive) use in athletic training facilities or at home
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical testing was provided in this 510(k):
Biocompatibility Testing: Skin contacting hydrogel, which is used in PowerDot electrode pads, has been tested to ISO 10993-1:2009 standard. TPU. ABS and PVC Compound materials, used in PowerDot PD-01 device housing and lead cables, were evaluated for biocompatibility based on Material Safety Data Sheets provided by the material vendors, and were concluded to be safe and biocompatible.
Software Verification and Validation: PowerDot Firmware and PowerDot Mobile Application software documentation, consistent with a moderate level of concern, is provided with this 510(k). System Validation Testing proves that all software requirement specifications were met and all software hazards were mitigated to Accepted risk level.
Electrical Safety and Electromagnetic Compatibility Testing: PowerDot PD-01 device together with its controlling PowerDot Mobile Application has been designed to comply and tested for compatibility with the applicable clauses of the following FDA-recognized standards: IEC/EN 60601-1:2005, IEC 60601-2-10:2012, IEC/EN 60601-1-2:2014, IEC/EN 60601-1-11:2010.
Battery Testing: Lithium-Polymer battery, used in PowerDot PD-01 was tested by battery manufacturer for compliance with FDA-recognized UL 1642 Standard for Lithium Batteries (Cells).
Engineering Bench Testing: Oscilloscope tracings were obtained of the device output waveforms under maximum supported voltage and pulse widths under loads of 500 Ω, 2 kΩ and 10 kΩ. A number of system validation testing scenarios covering mitigation of wireless risks in accordance with FDA's "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff" were added to our full system testing protocol.
No applicable clinical performance data. This device does not diagnose, cure, mitigate, treat or prevent disease or affect the function of the human body. Clinical effectiveness of the device was based on a literature review.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Compex® Sport Plus (K083140)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name arranged in a circular fashion around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, formed by three intertwined figures in profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2015
Smartmissimo Technologies Pte Ltd Alexey Pisarev Chief Executive Officer #28-01, Sgx Centre II, 4 Shenton Way Singapore, 068807 SG
Re: K150078
Trade/Device Name: PowerDot Pd-01 Muscle Stimulator (with PowerDot Mobile Application) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: August 18, 2015 Received: August 31, 2015
Dear Alexey Pisarev:
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 device
1
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/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) K150078
Device Name
PowerDot® PD-01 Muscle Stimulator (with PowerDot® Mobile Application)
Indications for Use (Describe)
The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☐ Registration Use (Part 21 CFR 201.Subpart D) |
|---|
| ☑ Over-The-Counter Use (21 CFR 201.Subpart C) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
This summary is being submitted in accordance with the reguirements of 21 CFR 807.92.
5.1 Submitter
Smartmissimo Technologies Pte Ltd. 4 Shenton Way, #28-01 SGX Centre II, Singapore, 068807
Contact: Alexey Pisarev, Chief Executive Officer Tel. +65 83216256 Email: alexey@getpowerdot.com
5.2 Date Prepared: Sept 29, 2015
5.3 Device Name and Classification Information:
Trade/Proprietary Name: PowerDot® PD-01 Muscle Stimulator (with PowerDot® Mobile Application) Common Name: Smart Wearable Sports Muscle Stimulator Classification Name: Powered Muscle Stimulator for Muscle Conditioning Classification: 21 CFR 890.5850, Class II Product Code: NGX Panel: 89, Physical Medicine
5.4 Predicate Device: Compex® Sport Plus (K083140)
5.5 Device Description:
PowerDot PD-01 Muscle Stimulator is a battery-powered neuromuscular stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance and, with that regard, may be considered a technique or method for muscle training.
PowerDot PD-01 device is designed to be used together with PowerDot Mobile Application.
PowerDot PD-01 device uses Bluetooth™ Low Energy (Bluetooth 4.0, Class II) wireless radio frequency protocol for communication with supported range of mobile devices (such as smartphones and/or tablets) via PowerDot Mobile Application.
Accessories include lead cables of 2 different lengths, USB charging cable, 2 types of hydrogel-based self-adhesive electrode pads and carrying case.
5.6 Indications for Use:
The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be
4
used in conjunction with therapy or treatment diseases of medical conditions of any kind.
5.7 Contraindications
PowerDot PD-01 device and PowerDot Mobile Application should not be used by anyone with a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.
| Parameter | PowerDot PD-01 (with
PowerDot Mobile
Application) | Compex Sport Plus
(K083140) | Substantial
Equivalence |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use and Indications
For Use | The PowerDot PD-01 device
with PowerDot Mobile
Application is intended for
the stimulation of healthy
muscles in order to improve
or facilitate muscle
performance. The PowerDot
PD-01 device and PowerDot
Mobile Application are not
intended to be used in
conjunction with therapy or
treatment diseases of medical
or medical conditions of any
kind. | Intended for the
stimulation of healthy
muscles in order to
improve or facilitate
muscle performance.
Compex Sport is not
intended to be used in
conjunction with
therapy or treatment of
medical diseases or
medical conditions of
any kind. Usage of any
of Compex Sport
programs on injured or
ailing muscles is
contraindicated. | Same |
| Use environment | Over-the-counter (non-
prescriptive) use in athletic
training facilities or at home | Over-the-counter (non-
prescriptive) use in
athletic training
facilities or at home | Same |
| Anatomical Sites | Electrodes can be applied to
multiple anatomical sites. | Electrodes can be
applied to multiple
anatomical sites. | Same |
| Stimulation Parameters | | | |
| Power Source | Battery, Li-Po, rechargeable.
Not replaceable by user. | Battery, Ni-MH,
rechargeable | Substantially
equivalent. Both
devices are
powered with
rechargeable
batteries. |
| Method of Line Current
Isolation | N/A | N/A | |
| Patient Leakage Current | | | Unable to
compare.
Leakage current
of PowerDot
PD-01 is
extremely low
and meets IEC
60601-1 safety
criteria. |
| - Normal Condition |