Identifiers
- 510(k) Number
- K171092 FDA 510(k)
- FDA Product Code
- NGX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The XiniWave II Model ECS322P is a Powered Muscle Stimulator (Classification Name: Stimulator, Muscle, Powered, For Muscle Conditioning) designed for muscle conditioning and rehabilitation. It delivers transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES) via user-selectable programs controlled through a keypad interface. This Class II device operates on battery power and is intended for both over-the-counter and prescription use in physical medicine applications.
The device is supplied as a reusable, non-sterile Class II medical instrument, with no specific MRI safety restrictions noted. It is housed in a lightweight, sturdy cabinet and features identical keypad controls and circuitry to its predicate device. Authorized for commercial distribution in the United States under FDA 510(k) clearance (K171092), the XiniWave II Model ECS322P falls under the Product Code NGX and was reviewed by the Physical Medicine (PM) Advisory Committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: XiniWave II Model ECS322P (K171092) — FDA 510(k) | Innolitics, PDF Microsoft Word - K171092 XiniWave II NGX & NUH S007 Section 5.0 Summary ..., XiniWave II Model ECS322P 510 (k) K171092 - FDA.report, XiniWave II Model ECS322P (K171092) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171092 | Class II | Active |
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Manufacturer
- Manufacturer
- International Trade Group Inc
- FDA Applicant
- International Trade Group, Inc.
Sources (1)
- FDA 510(k) K171092 24 fields · synced Oct 6, 2026