(101 days)
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
The Avail device is a wireless, independent dual channel wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain on multiple body locations. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology and microcurrent therapy through the simple, convenient use of the dedicated Omron TENS iOS or Android App. Reusable, self-adhesive, contouring pads allow for discreet and convenient placement on multiple pain locations on the body. The Avail system can be programmed to deliver nine different TENS modes and a microcurrent therapy mode.
The system contains two main TENS units which are rechargeable and each can be attached to either a medium or large size gel pad. The pad with attached TENS unit can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Avail TENS system is completed through the available Omron TENS App. The Avail will be packaged with an Instruction Manual which provides details on setting up the device for use, installing of the Omron TENS App, setting and controlling therapy modes, and troubleshooting. The system includes two main TENS units, medium and large pads, an AC-powered charger, AC adapter, a pad holder and storage case.
The Omron Avail (Model PM601) is a Transcutaneous Electrical Nerve Stimulator (TENS) device intended for pain relief.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by the features and performance of the predicate and reference devices, as the submission aims to demonstrate substantial equivalence. The reported device performance is then compared against these.
| Feature / Acceptance Criteria Category | Acceptance Criteria (from predicate/reference) | Reported Device Performance (Omron Avail PM601) |
|---|---|---|
| Classification | - Regulation: 21 CFR §882.5890 (Transcutaneous electrical nerve stimulator for pain relief) |
- Product Code: Primary: NUH, Secondary: NYN, NGX (for predicate) | - Regulation: 21 CFR §882.5890
- Product Code: Primary: NUH, Secondary: NYN |
| Indications for Use | - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household/work activities (PulseRelief, Omron Heat Pain Pro, Painmaster MCT Patch). - Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (SmartRelief). | - 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.
- Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (using Tap, Shoulder, Arm or Leg mode). |
| Environment of Use | Clinics, hospital, and home environments (Omron Heat Pain Pro); Home (PulseRelief, Painmaster MCT Patch). | Clinics, hospital and home environments. |
| Patient Population | Adults (all comparing devices); Over 12 years of age unless under physician supervision (Painmaster MCT Patch). | Adults. |
| Contraindications | Similar contraindications regarding pacemakers, implanted defibrillators, other implanted electronic/metallic devices (all comparing devices). Avoid placement along neck/through head for Painmaster. | Do not use if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. |
| Power Source | Rechargeable Lithium-ion battery (PulseRelief, Omron Heat Pain Pro); 3V CR2032 lithium battery (SmartRelief); Primary battery only, one-time use (Painmaster). | Rechargeable Lithium-ion battery. |
| Patient Leakage Current |
§ 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).