Identity
- Trade Name
- Freedom Spinal Cord Stimulator System FDA UDI
- Generic Name
- Implantable spinal cord electrical stimulation system programmer FDA UDI
- Device Name
- Freedom Spinal Cord Stimulator System Longboard Wearable Antenna Assembly 915 FDA UDI
- Model / Reference
- LBRD-915-2K FDA UDI
- Description
- Freedom Spinal Cord Stimulator System Longboard Wearable Antenna Assembly 915 FDA UDI
Identifiers
- Catalog Number
- LBRD-915-2K FDA UDI
- Primary DI / UDI-DI
- 00859619004035 FDA UDI
- 510(k) Number
- K150517 FDA UDI
- FDA Product Code
- GZB FDA UDI
- GMDN Term
- Implantable spinal cord electrical stimulation system programmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Implantable spinal cord electrical stimulation system programmer
Freedom Spinal Cord Stimulator System by Stimwave Technologies Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K150517 also covers:
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stimwave Technologies Incorporated
Sources (1)
- FDA UDI 1a43b5a1-33c2-4c6f-9f10-9275286e4e8d 36 fields · synced May 31, 2026