Identifiers
- 510(k) Number
- K210979 FDA 510(k)
- FDA Product Code
- IPF 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)
Prelivia is a neurostimulation device designed to prevent and reverse pressure wounds. It functions by promoting tissue health to protect patients from pressure injury.
This device has received FDA 510(k) clearance. It is manufactured by Rehabtronics, Inc. and is categorized under product code IPF.
Frequently asked questions
What is the primary function of the Prelivia device?
Prelivia is a neurostimulation device designed to protect patients from pressure injuries. It functions by promoting tissue health, which helps to both prevent the development of pressure wounds and reverse existing ones.
What is the regulatory status of the Prelivia device?
The Prelivia device has received FDA 510(k) clearance under K-number K210979. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of the Prelivia neurostimulation system?
Prelivia is manufactured by Rehabtronics, Inc., a company based in Edmonton, Canada. The device is categorized under product code IPF and falls under the oversight of the Physical Medicine 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: Prelivia - WoundSource, NeuroKinetic Acquires Rehabtronics and Launches Prelivia for ... - LinkedIn, FDA Clears Prelivia, a Medical Device that Protects Patients from ..., Rehabtronics Selected by Praxis Spinal Cord Institute to Launch ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210979 | Class II | Active |
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Manufacturer
- Manufacturer
- Rehabtronics, Inc.
Sources (1)
- FDA 510(k) K210979 24 fields · synced Sep 21, 2026