System-Mini, Models: 390, E30
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072294 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 System-Mini is a medical device with models 390 and E30, designed for physical medicine applications. It is a compact system intended for therapeutic use in medical settings.
The device is supplied by Bio-Medical Research, Ltd. and has received FDA 510(k) clearance with K number K072294. It is authorized for use in physical medicine and is stored at the manufacturer's facility in Galway, Ireland.
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: SYSTEM-MINI, MODELS: 390, E30 (K072294) — FDA 510(k) | Innolitics, SYSTEM-MINI, MODELS: 390, E30 510(k) K072294 - FDA.report, PDF K072294 - System-mini, Models: 390, E30, Device Listing 1244713305 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072294 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Medical Research, Ltd.
Sources (1)
- FDA 510(k) K072294 24 fields · synced Oct 6, 2026