Freedom Spinal Cord Stimulator System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150517 FDA 510(k)
- FDA Product Code
- GZB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5880 FDA 510(k)
- Regulation Number
- 882.5880 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Freedom Spinal Cord Stimulator System is an implanted stimulator device intended for pain relief. It delivers electrical pulses to the spinal cord to modulate pain signals.
The system is supplied as an implanted device and is regulated under FDA 510(k) clearance (K150517) as a Class II device. It is used in clinical settings for pain management and is not described as sterile, single-use, or MRI-safe in the provided data.
Frequently asked questions
What is the intended clinical use of the Freedom Spinal Cord Stimulator System?
It is designed to be implanted for pain management by delivering electrical pulses to the spinal cord, which modulate pain signals and provide relief for patients with chronic pain conditions.
How is the Freedom system supplied and what are its sterility or reuse characteristics?
The system is supplied as a fully implanted device. The provided data does not specify sterility status, nor does it indicate whether the device is single‑use or intended for reuse, so those details would need clarification from the manufacturer.
Under which regulatory pathway was the Freedom Spinal Cord Stimulator System cleared?
It received FDA 510(k) clearance (K150517) as a Class II device, classified under the neurology advisory committee with a traditional clearance type, indicating it is substantially equivalent to a predicate device.
What size or model variations are available for the Freedom system?
The data only references the Freedom Spinal Cord Stimulator System as a single product name without mentioning multiple sizes or model numbers, suggesting a single configuration is offered.
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: PDF StimWave Wireless Pain Relief - National Institutes of Health, PDF freedom Spinal Cord StimulatorsTM, Stimwave Technologies Update
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150517 | Class II | Active |
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Manufacturer
- Manufacturer
- Stimwave Technologies Incorporated
Sources (1)
- FDA 510(k) K150517 24 fields · synced Sep 22, 2026