Predicate Devices

K141978 - Omron - PM3032, K172079 – Omron - Avail

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard TENS device functionality and regulatory compliance, with no mention of AI or ML. The software control is described in terms of managing functions and waveform characteristics, which is typical for modern medical devices and does not inherently indicate AI/ML.

Therapeutic

Yes

The device's intended use is for the relief of pain, which classifies it as a therapeutic device.

Diagnostic

No

Explanation: The device description states its intended use is for "relief of pain" and describes it as a "TENS device for pain relief." There is no mention of it being used to identify or diagnose any medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "small, battery operated TENS device" and mentions accessories like an electrode cord/cable and electrode pads, indicating it is a hardware device with software control.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Description: The provided description clearly states that this device is a TENS (Transcutaneous Electrical Nerve Stimulator). It works by applying electrical stimulation to the skin for pain relief.
Intended Use: The intended use is for the relief of pain associated with sore or aching muscles and chronic pain. This is a therapeutic use, not a diagnostic one based on analyzing biological samples.
Mechanism of Action: TENS devices work by interacting with the nervous system through electrical impulses applied externally, not by analyzing biological samples.

Therefore, based on the description and intended use, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.

Product codes (comma separated list FDA assigned to the subject device)

NUH, NYN

Device Description

The Omron Healthcare Maxpower Relief Model PM3032B is a small, battery operated TENS device for pain relief intended for OTC use. It complies with ES60601-1, IEC60601-1-2, IEC60601-2-10 and IEC 60601-1-11.

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.

The Omron Healthcare Maxpower Relief Model PM3032B is software controlled which includes all functions, indicators and waveform characteristics.

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 work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.

The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part. These are identical to the accessories cleared in K141978.

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

Environments of Use: Clinics, hospital and home environments
Intended User: OTC

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:
Bench testing was performed to ensure all requirements have been met, including:

Testing of all controls
Testing of all indicators
Testing of battery state indicators
Testing of waveforms

The device was 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: 2014 Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Disturbances - Requirements and Tests
IEC 60601-1-11: 2015, 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: 2016 Medical electrical equipment - part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators

The device was also tested for drop, vibration and environmental temperature and humidity in accordance with IEC 60601-1-11.

Clinical Testing Summary:
No clinical testing was performed.

Usability:
Usability testing has not been performed on the PM3032B as it is identical to the predicate device Maxpower Relief (K141978).

Biocompatibility of Patient Contacting Materials:
In accordance with ISO 10993-1, this is a surface device, skin (un-breached, not compromised), limited duration (

Regulation Number and Section

§ 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).

Summary

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January 10, 2019

Omron Healthcare, Inc. % Paul Dryden Consultant Omron Healthcare, Inc. c/o ProMedic, LLC. 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K182120

Trade/Device Name: Omron Healthcare Maxpower Relief Model PM3032B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NYN Dated: October 11, 2018 Received: October 12, 2018

Dear Paul Dryden:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Pamela D. Scott -S

Carlos L. Peña, PhD, MS 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) K182120

Device Name

Omron Healthcare Maxpower Relief Model PM3032B

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 work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.

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)

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510(k) Summary Page 1 of 10 1/7/2019

| Omron Healthcare, Inc.
1925 West Field Court

Lake Forest, IL 60045 USA	Tel - 847-247-5626
	Fax- 847-680-6269
Official Contact:	Renee Thornborough – Executive Director QA/RA
Proprietary or Trade Name:	Omron Healthcare Maxpower Relief Model PM3032B
Common/Usual Name:	Transcutaneous electrical nerve stimulator for pain relief
Classification Name/Code:
21CFR 882.5890	NUH - stimulator, nerve, transcutaneous, over-the-counter
NYN - stimulator, electrical, transcutaneous, for arthritis
Class II
Device Name:	Omron Healthcare Maxpower Relief Model PM30321
Predicate Devices:	K141978 - Omron - PM3032
K172079 – Omron - Avail

Device Description:

The Omron Healthcare Maxpower Relief Model PM3032B is a small, battery operated TENS device for pain relief intended for OTC use. It complies with ES60601-1, IEC60601-1-2, IEC60601-2-10 and IEC 60601-1-11.

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.

The Omron Healthcare Maxpower Relief Model PM3032B is software controlled which includes all functions, indicators and waveform characteristics.

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 work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.

The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part. These are identical to the accessories cleared in K141978.

As above the device is battery powered there is no connection to AC mains supply nor connection to any other device.

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510(k) Summary Page 2 of 10 1/7/2019

This submission is for expanding the indications for use to include indications associated with product code NYN. The device is identical to the Maxpower Relief (Model PM3032) cleared under K141978 except the CPU and related components are changed for cost saving purpose. UDI has also added on the main unit and the packaging. There are no other changes (appearance, dimension, materials, waveforms, modes). The accessories are identical to the Maxpower Relief (Model PM3032) cleared under K141978

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 2 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 work activities.

When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.

Environment of Use:

Clinics, hospital and home environments

Contraindications:

Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

Predicate Device Comparison:

Table 1 outlines the features of the Omron Healthcare Maxpower Relief Model PM3032B and compares it to the predicates that are being used to establish substantial equivalence.

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510(k) Summary

Device Comparison

	New Device	Primary Predicate	Secondary Predicate	Comment
Feature	Omron Healthcare
Maxpower Relief Model	Device
PM3032	Device
Omron Avail
	PM3032B	(MaxPower relief)	K172079
		K141978
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 work activities.
When used for the
symptomatic relief and
management of chronic,
intractable pain and relief of
pain associated with arthritis,
use the Shoulder mode of
stimulation.
Environments of Use: Clinics,
hospital and home
environments
Patient Population: Adult	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 work
activities.
Environments of Use:
Clinics, hospital and
home environments
Patient Population: Adult	The Avail is intended for
the relief of pain
associated with sore or
aching muscles of the
lower back, arms, legs,
shoulders or feet due to
strain from exercise or
normal household work
activities.
When used for the
symptomatic relief and
management of chronic,
intractable pain and relief
of pain associated with
arthritis, use the Tap,
Shoulder, Arm or Leg
mode of stimulation.
Environments of Use:
Clinics, hospital and
home environments
Patient Population: Adult	Identical to
Maxpower Relief
for temporary
relief of pain with
sore and aching
muscles.
Similar to Avail
with respect to
symptomatic relief
and management
of chronic,
intractable pain,
and relief of pain
associated with
arthritis.
Environments of Use:	Clinics, hospitals and home
environments	Clinics, hospitals and
home environments	Clinics, hospitals and
home environments	Identical
Patient Population	Adult	Adult	Adult	Identical
Classification - Regulation	21 CFR §882.5890,
Transcutaneous electrical	21 CFR §882.5890,
Transcutaneous electrical	21 CFR §882.5890,
Transcutaneous electrical	Identical
Feature	New Device
Omron Healthcare
Maxpower Relief Model
PM3032B	Primary Predicate
Device
PM3032
(MaxPower relief)
K141978	Secondary Predicate
Device
Omron Avail
K172079	Comment
	nerve stimulator for pain
relief	nerve stimulator for pain
relief	nerve stimulator for pain
relief
Classification - Product Code	Primary: NUH - stimulator,
nerve, transcutaneous, over-
the-counter
Secondary: NYN - stimulator,
electrical, transcutaneous, for
arthritis.	NUH - stimulator, nerve,
transcutaneous, over-the-
counter	Primary: NUH -
stimulator, nerve,
transcutaneous, over-the-
counter
Secondary: NYN -
stimulator, electrical,
transcutaneous, for
arthritis.	Proposed device
and secondary
predicate device
have the same
medical device
product code.
Prescriptive	No, OTC	No, OTC	No, OTC	Identical
Contraindications/Warning/Precautions	Contraindications
Do not use this device if you
have a cardiac pacemaker,
implanted defibrillator, or
other implanted metallic or
electronic device. Such use
could cause electric shock,
burns, electrical interference,
or death.	Contraindications
Do not use this device if
you have a cardiac
pacemaker, implanted
defibrillator, or other
implanted metallic or
electronic device. Such
use could cause electric
shock, burns, electrical
interference, or death.	Contraindications
Do not use this device if
you have a cardiac
pacemaker, implanted
defibrillator, or
otherimplanted metallic
or electronic device. Such
use could cause electric
shock, burns, electrical
interference, or death.	Identical
Single Use	Pads are for single patient use	Pads are for single patient
use	Patient-contacting Pads
are for single patient use	Identical to
MaxPower Relief
Sterility	External contacting device,
nonsterile	External contacting
device, nonsterile	External contacting
device, nonsterile	Identical
Over-the-Counter (OTC)	Yes	Yes	Yes	Identical

1/7/2019
Feature		New Device
Omron Healthcare
Maxpower Relief Model
PM3032B	Primary Predicate
Device
PM3032
(MaxPower relief)
K141978	Secondary Predicate
Device
Omron Avail
K172079	Comment
Power Source(s)		Two AAA alkaline batteries	Two AAA alkaline
batteries	Rechargeable lithium Ion
battery	Identical to
Maxpower Relief
- Method of Line Current Isolation		N.A.(internal power source)	N.A.(internal power
source)	N.A.(internal power
source)	Identical
Patient Leakage Current - Normal
Condition (uA)		1	1