(315 days)
Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.
Transcutaneous Electrical Nerve Stimulator sends gentle electrical current to underlying nerves and muscle groups via electrodes applied onto the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a lithium battery-powered device comprising the electronic stimulatory module, the accessories of lead wires, the electrodes and the adapter. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes are 510(k) cleared devices (K192568). Size 50*50mm.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document describes the acceptance criteria in terms of compliance with various international standards for medical electrical equipment and a comparison to a predicate device. The reported performance is implicitly stated by asserting compliance with these standards and the substantial equivalence to the predicate.
| Criteria Category | Acceptance Criteria (from referenced standards or predicate comparison) | Reported Device Performance (as stated in the document) |
|---|---|---|
| General Safety & Essential Performance | Compliance with Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (ANSI AAMI ES60601-1: 2005/(R) 2012 And A1: 2012, C1: 2009/(R) 2012 And A2: 2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1: 2005, MOD)) | Bench tests demonstrated the device met all design specifications. Specifically, it passed ANSI AAMI ES60601-1. The differences in power source, output intensity control, average DC current at no load, number of output modes, channel output design and isolation methods, automatic no trip, user override control, net charge, maximum phase charge, maximum average current, maximum current density, and maximum average power density were evaluated and found to not raise any new safety or effectiveness issues, demonstrating compliance with the standard's safety limits. |
| Nerve & Muscle Stimulator Specifics | Compliance with Medical Electrical Equipment - Part 2-10: Particular Requirements for the Basic Safety and Essential Performance Of Nerve and Muscle Stimulators (IEC 60601-2-10 Edition 2.1 2016-04) | The device passed IEC 60601-2-10 tests. All programs passed these tests. The differences in power source, output intensity control, average DC current at no load, number of output modes, channel output design and isolation methods, automatic no trip, user override control, net charge, maximum phase charge, maximum average current, maximum current density, and maximum average power density were evaluated and found to not raise any new safety or effectiveness issues, demonstrating compliance. |
| Electromagnetic Compatibility (EMC) | Compliance with Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests (IEC 60601-1-2 Edition 4.0 2014-02) | The device passed IEC 60601-1-2. |
| Home Healthcare Environment | Compliance with Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety and Essential Performance -- Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Equipment and Medical Electrical Systems Used in Home Healthcare Environment (IEC 60601-1-11 Edition 2.0 2015-01) | The device passed IEC 60601-1-11. |
| Power Source(s) | Complies with IEC 60601-1 requirements. | DC3.7 V Li-battery powered. Considered "Similar" to predicate but complies with IEC 60601-1. Differences will not raise safety or effectiveness issues. |
| Output Intensity Control | Complies with IEC 60601-1 requirements. | Current control. Considered "Similar" to predicate but complies with IEC 60601-1. Differences will not raise safety or effectiveness issues. |
| Average DC current at no load | Similar to predicate device and passes AAMI / ANSI ES60601-1 and IEC 60601-2-10 tests. |
§ 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).