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Wearable Antenna Assembly/StimQ Wearable Antenna Gear
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Wearable Antenna Assembly/StimQ Wearable Antenna Gear FDA UDI
- Generic Name
- Multiple active implantable device programmer FDA UDI
- Device Name
- Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Wearable Antenna Assembly/StimQ Wearable Antenna Gear FDA UDI
- Model / Reference
- PDBT-915-2K FDA UDI
- Description
- Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Wearable Antenna Assembly/StimQ Wearable Antenna Gear FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818225020822 FDA UDI
- FDA Product Code
- GZF FDA UDIGZB FDA UDI
- GMDN Term
- Multiple active implantable device programmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5870 FDA UDI882.5880 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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Multiple active implantable device programmerImplantable spinal cord electrical stimulation system programmer
Wearable Antenna Assembly/StimQ Wearable Antenna Gear by Stimwave Technologies Incorporated — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Implantable spinal cord electrical stimulation system programmer.
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Cleared under the same submission
K170141 also covers:
- Battery Charger — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom-4A Receiver Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom-4A Receiver Kit Channel B US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom-4A Spare Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom-4A Spare Kit Channel B US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom-4A Trial Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom-4A Trial Kit Channel B US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom-8A Receiver Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom-8A Receiver Kit Channel B US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom-8A Spare Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom-8A Spare Kit Channel B US w/Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom-8A Trial Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
K171366 also covers:
- Battery Charger — STIMWAVE TECHNOLOGIES INCORPORATED
- Sterile Revision Kit — STIMWAVE TECHNOLOGIES INCORPORATED
- StimQ Freedom-4A Receiver Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- StimQ Freedom-4A Receiver Kit Channel B US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- StimQ Freedom-4A Spare Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- StimQ Freedom-4A Spare Kit Channel B US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- StimQ Freedom-4A Trial Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- StimQ Freedom-4A Trial Kit Channel B US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- StimQ Freedom-8A Receiver Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- StimQ Freedom-8A Receiver Kit Channel B US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- StimQ Freedom-8A Spare Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATED
- StimQ Freedom-8A Spare Kit Channel B US w/Receiver — 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 d42803dd-e439-45d4-bdd0-a4c365811b6d 35 fields · synced May 30, 2026