Identifiers
- 510(k) Number
- K071113 FDA 510(k)
- FDA Product Code
- GZI FDA 510(k)
- Models / Variants
- Fa100052 FDA 510(k)Rt300-Sp (pediatric Version) FDA 510(k)Model Fa100053 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5810 FDA 510(k)
- Regulation Number
- 882.5810 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Rt300-S (Fa100052 +2 more) by Restorative Therapies, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071113 | Class II | Active |
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Manufacturer
- Manufacturer
- Restorative Therapies, Inc.
Sources (1)
- FDA 510(k) K071113 24 fields · synced Jun 18, 2026