(135 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description is consistent with a standard TENS device controlled by software for waveform characteristics and basic functions.
Yes
The device is described as a TENS device intended for the relief of pain, which aligns with the definition of a therapeutic device.
No
Explanation: The device description states its purpose is for "relief of pain associated with sore or aching muscles," and it is identified as a TENS device for pain relief. There is no mention of it being used to diagnose conditions or processes.
No
The device description explicitly states it is a "small, battery operated TENS device" and includes physical components like an electrode cord/cable and electrode pads, indicating it is a hardware device with software control, not a software-only device.
No, 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.
- Device Function: The description clearly states that this device is a TENS (Transcutaneous Electrical Nerve Stimulation) device. It works by applying electrical stimulation to the skin to relieve pain. It does not analyze any biological samples.
- Intended Use: The intended use is for the relief of pain associated with sore or aching muscles, which is a therapeutic application, not a diagnostic one.
The information provided describes a medical device used for pain relief through electrical stimulation, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
"This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulder or foot due to strain from exercise or normal household and work activities."
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
"The Maxpower relief (Model PM3032) is a small, battery operated TENS device for pain relief intended for OTC use. The device complies with AAMI ANSI ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
The output modes are intended for application to the following areas: lower back, arms, legs, shoulder or foot. The specifications of each mode will be discussed in greater detail later in this section.
Software controls all controls and indicators. Software controls waveform characteristics.
This device is intended for the relief of pain associated with sore or aching, muscles of the shoulder, lower back, arms, or legs due to strain from exercise or normal household and work activities.
The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part.
As above the device is battery powered there is no connection to AC mains supply nor connection to any other device."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back, arms, legs, shoulder or foot
Indicated Patient Age Range
Adult
Intended User / Care Setting
Intended User OTC
Environments of Use: Clinics, hospital and home environments
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)
Non-Clinical Testing Summary:
"The device has been tested to insure that all requirements have been met, this includes:
- Testing of all controls
- Testing of all indicators
- Testing of battery state indicators
- Testing of waveforms
The device has also been tested to the requirements of the following standards: - AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment part 1: general requirements for basic safety and essential performance
- IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility -Requirements and Tests
- IEC 60601-1-11: 2010, medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-10: 2012 Medical electrical equipment part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators
The device has also been tested for drop, vibration and environmental temperature and humidity
Usability testing has also been performed."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of a human figure, with the head, torso, and legs represented by curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MAR 16 2015
Omron Healthcare, Inc. % Paul Dryden Consultant ProMedic. Inc. 24301 Woodsage Dr. Bonita Springs, Florida 34134
Re: K141978
Trade/Device Name: Maxpower relief (PM3032) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: July 19, 2014 Received: October 21, 2014
Dear Mr. Dryden,
This letter corrects our substantially equivalent letter of December 3, 2014.
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.
1
Page 2 - Mr. Paul Dryden
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-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" (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, PhD, MS Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Maxpower relief (PM3032) Indications for Use (Describe)
This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulder or foot due to strain from exercise or normal household and work activities.
Environments of Use: Clinics, hospital and home environments
Patient Population: Adult
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
510(k) Summary Page 1 of 9 1/30/2015
| Omron Healthcare, Inc.
1925 West Field Court
Lake Forest, IL 60045 USA | Tel - 847-247-5626
Fax- 847-680-6269 |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Official Contact: | Renee Thornborough - Director QA/RA |
| Proprietary or Trade Name: | PM3032 |
| Common/Usual Name: | Transcutaneous electrical nerve stimulator for pain
relief. |
| Classification Name/Code: | NUH - stimulator, nerve, transcutaneous,
over-the-counter
21CFR 882.5890
Class II |
| Device Name: | Maxpower relief |
| Predicate Devices: | K110068 - Omron - PM3030
K121757 - Healthmate International - Pro8AB |
Device Description:
The Maxpower relief (Model PM3032) is a small, battery operated TENS device for pain relief intended for OTC use. The device complies with AAMI ANSI ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
The output modes are intended for application to the following areas: lower back, arms, legs, shoulder or foot. The specifications of each mode will be discussed in greater detail later in this section.
Software controls all controls and indicators. Software controls waveform characteristics.
This device is intended for the relief of pain associated with sore or aching, muscles of the shoulder, lower back, arms, or legs due to strain from exercise or normal household and work activities.
The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part.
As above the device is battery powered there is no connection to AC mains supply nor connection to any other device.
4
510(k) Summary Page 2 of 9 1/30/2015
We have provided the information suggested in Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use from April 5, 2010. A checklist in accordance with this guidance can be found in Section 18 of this submission
Intended User OTC
Patient Population
Adults
Indications for Use:
This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulder or foot due to strain from exercise or normal household and work activities.
Environment of Use:
Clinics, hospital and home environments
Contraindications:
- Use with a pacemaker or other implanted metallic or electronic device. ●
- Use with a life-supporting medical electronic device such as an artificial heart or . lung or respirator
- Use in the presence of monitoring equipment (e.g. cardiac monitors, ECG alarms) ●
- Simultaneous connection of a patient to a high frequency surgical unit ●
- Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy . equipment
- . Use with another TENS device
Predicate Device Comparison:
The Maxpower relief (PM3032) was compared to the predicates PM3030- K110068 and Healthmate Pro-8B - K121757 in the device comparison Table 5.1 below. Detailed electrical characteristics are provided in Table 5.2.
5
Table 5.1 Device Comparison
:
| Model Name
510(k) Number | New Device
Maxpower relief (PM3032) | Predicate Device
PM3030
K110068 | Predicate Device
Pro-8AB
K121757 | Comment |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Manufacturer | OMRON HEALTHCARE | OMRON HEALTHCARE | Healthmate International | |
| Indications for use | This device is intended for the
relief of pain associated with
sore or aching muscles of the
lower back, arms, legs,
shoulder or foot due to strain
from exercise or normal
household and work activities. | This device is intended 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. | To be used for temporary
relief of pain 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. | Substantially
equivalent |
| Prescriptive | No, OTC | No, OTC | No, OTC | Identical |
| Power Source(s) | two AAA alkaline batteries | two AAA alkaline batteries | Rechargeable battery | PM3030 and
PM3032 identical |
| - Method of Line Current Isolation | N.A. not line powered | N.A. not line powered | N.A. not line powered | Identical all battery
powered |
| Patient Leakage Current - Normal
Condition (uA) | 1 |