(332 days)
No
The summary describes a standard TENS device with different output modes for specific body areas. There is no mention of AI, ML, or any features that would suggest adaptive or learning capabilities. The performance studies focus on waveform characteristics, not algorithmic performance.
Yes
The device is described as a TENS device intended for the relief of pain, which is a therapeutic purpose.
No
Explanation: This device, a TENS unit, is intended for pain relief by stimulating muscles, not for diagnosing medical conditions. Its function is therapeutic, not diagnostic.
No
The device description explicitly states it is a "small, battery operated, three (3) output mode TENS device" and mentions accessories like electrode cords and pads, indicating it is a hardware device with software control, not a software-only device.
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 is described as a TENS (Transcutaneous Electrical Nerve Stimulation) device. TENS devices deliver electrical impulses to the body for pain relief. This is a physical therapy modality, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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, or legs due to strain from exercise or normal household and work activities.
Product codes
NUH
Device Description
The PM3030 is a small, battery operated, three (3) output mode TENS device for pain relief intended for OTC use.
The output modes are intended for application to the following areas: Shoulder/Arm, Lower Back and Ley/Foot. The specifications of each mode will be discussed in greater detail later in this section.
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.
The device has been tested to and meets the requirements of the following recognized consensus standards:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic:Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
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
Adult
Intended User / Care Setting
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
Performance testing has been performed that shows equivalent waveform characteristics.
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
Omron OTC TENS
Premarket Notification 510(k) Section 5 - 510(k) Summary
510(k) Summary Page 1 of 6 7-Jan-11
| Omron Healthcare, Inc.
1200 Lakeside Dr.
| Bannockburn, IL 60015 | Tel - 847-247-5626 |
|---|---|
| Fax - 847-680-6911 | |
| Official Contact: | Mirna DiPano - Director of Quality & Regulatory |
| Proprietary or Trade Name: | PM3030 |
| Common/Usual Name: | Stimulator, nerve, transcutaneous, over-the-counter |
| Classification Name/Code: | NUH - stimulator, nerve, transcutaneous, over-the-counter |
| 21 CFR 882.5890 | |
| Device: | PM3030 |
| Predicate Devices: | Endurance Therapeutics, Model T1040, 510(k) K060846 |
Device Description:
The PM3030 is a small, battery operated, three (3) output mode TENS device for pain relief intended for OTC use.
The output modes are intended for application to the following areas: Shoulder/Arm, Lower Back and Ley/Foot. The specifications of each mode will be discussed in greater detail later in this section.
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.
The device has been tested to and meets the requirements of the following recognized consensus standards:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
1
Omron OTC TENS
510(k) Summary Page 2 of 6 7-Jan-11
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic:Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
Indications for Use:
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.
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.
- · Do not use this device together with a life-supporting medical electronic device such as an artificial heart or lung.
- · Do not use this device together with a body-worn medical electronic device such as an ECG.
2
Premarket Notification 510(k) Section 5 – 510(k) Summary
Omron OTC TENS
510(k) Summary Page 3 of 6 7-Jan-11
Summary of substantial equivalence
| Attribute | Model PM3030 | Predicate |
|---|---|---|
| Endurance Model T1040 | ||
| K060846 | ||
| Product Code | NUH | NUH, NGX, GZX |
| CFR | 882.5890 | 882.5890, 890.5850 |
| Indications for Use | 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 associated with sore and aching | ||
| muscles in the | ||
| lower back due to strain from | ||
| exercise or normal household work | ||
| activities choose | ||
| Manual modes 1, 2, 3, 4, 5, 6 or | ||
| Auto 4 | ||
| To be used for temporary relief of | ||
| pain associated with sore and aching | ||
| muscles in the | ||
| upper extremities (arm) due to strain | ||
| from exercise or normal household | ||
| work activities | ||
| choose Manual modes 1, 2, 3, 4, 5, | ||
| 6 or Auto 1 or Auto 3 | ||
| To be used for temporary relief of | ||
| pain associated with sore and aching | ||
| muscles in the | ||
| lower extremities (leg) due to strain | ||
| from exercise or normal household | ||
| work activities | ||
| choose Manual modes 1, 2, 6 or | ||
| Autol or Auto 4 | ||
| Used to stimulate healthy muscles | ||
| in order to improve and facilitate | ||
| muscle | ||
| performance choose Manual Mode | ||
| 1 or Auto Mode 2 | ||
| Prescription | ||
| Patient Population | Adult | Not specified |
| Prescriptive or OTC | OTC | OTC |
| Environment of use | Clinics, hospital and home environments | Not specified |
| Contraindications - do not use if you have a cardiac pacemaker, implanted defibrillator or other implanted metallic or electronic device | Yes | Yes |
| Warnings standard | Yes | Yes |
| Precautions - standard | Yes | Yes |
| Adverse reactions - standard | Yes | Yes |
| Power source | 2 - AAA | 3 - AAA |
| Number of Output modes | 3 | 10 |
| Number of output channels | 1 | 1 |
| Waveform | Biphasic | |
| Shape | Rectangular | |
| Maximum Output Voltage (max) | ||
| 500 ohm | 35.4 V | 40.7 |
| 2k ohm | 46.7 V | 105.1 |
| 10k ohm | 50.8 V | 154.1 |
| Maximum Output Current (max) | ||
| 500 ohm | 4.4 mA | 81.4 |
| 2k ohm | 1.7 mA | 47.8 |
| 10k ohm | 0.4 mA | 15.4 |
| Maximum Phase charge (500 ohm) | 133 microC | 16.9 microC |
| Maximum Current Density (500 ohm) | 0.095 mA/cm² | 2.71 mA/cm² |
| Maximum Average Current (500 ohm) | 3.5 mA | Not specified |
| Maximum Average Power Density (500 ohm) | 89 mW/cm² | 10.2 mW/cm² |
| Frequency (Hz) |