(157 days)
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
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 Omron Healthcare Maxpower Relief Model PM3032B is software controlled which includes all functions, indicators and waveform characteristics. 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.
The provided text describes the 510(k) summary for the Omron Healthcare Maxpower Relief Model PM3032B. This is a Transcutaneous Electrical Nerve Stimulator (TENS) device intended for pain relief. The submission aims to demonstrate substantial equivalence to predicate devices, K141978 (Omron MaxPower Relief) and K172079 (Omron Avail), to expand its indications for use.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable form for device performance. Instead, it demonstrates substantial equivalence by comparing various features of the new device to two predicate devices. The "performance" is generally described as "identical" or "equivalent" to the predicates, and compliance with recognized standards.
| Feature/Criterion | New Device (Omron Healthcare Maxpower Relief Model PM3032B) Performance | Comment (Relative to Predicates) |
|---|---|---|
| Indications for Use | Relief of pain associated with sore or aching muscles of lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. | |
| Added: Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (using Shoulder mode). | Identical to primary predicate (K141978) for initial indications. Similar to secondary predicate (K172079) for expanded indications. | |
| Environments of Use | Clinics, hospital, and home environments | Identical |
| Patient Population | Adult | Identical |
| Regulation Number | 21 CFR §882.5890 | Identical |
| Product Codes | Primary: NUH (stimulator, nerve, transcutaneous, over-the-counter) | |
| Secondary: NYN (stimulator, electrical, transcutaneous, for arthritis) | Shares NUH with primary predicate, shares NUH and NYN with secondary predicate. | |
| Prescriptive | No, OTC | Identical |
| Contraindications | Identical to predicates (cardiac pacemaker, implanted defibrillator, other implanted metallic/electronic device) | Identical |
| Single Use (Pads) | Pads are for single patient use | Identical to primary predicate. |
| Sterility | External contacting device, nonsterile | Identical |
| Power Source | Two AAA alkaline batteries | Identical to primary predicate. |
| Line Current Isolation | N.A. (internal power source) | Identical |
| Patient Leakage Current - Normal Condition | 1 µA | Identical to primary predicate (vs. |
§ 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).