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PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel A
FDA UDIClass II (US FDA UDI)
by Curonix
Identity
- Trade Name
- PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel A FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
- Device Name
- PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel A FDA UDI
- Model / Reference
- STQ4-RCV-A0 FDA UDI
- Description
- PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850051034406 FDA UDI
- 510(k) Number
- K152178 FDA UDI
- FDA Product Code
- GZF FDA UDI
- GMDN Term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel A by Curonix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable.
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Proclaim™ — ST. JUDE MEDICAL, INC. · Class III
- Proclaim™ — ST. JUDE MEDICAL, INC. · Class III
- Vanta™ AdaptiveStim™ — MEDTRONIC, INC. · Class III
- Evoke® Closed-Loop Stimulator (CLS) — SALUDA MEDICAL PTY LIMITED · Class III
- Altius IPG — Neuros Medical, Inc. · Class III
- Precision™ Montage™ MRI — Boston Scientific Neuromodulation · Class III
- Proclaim™ — ST. JUDE MEDICAL, INC. · Class III
Cleared under the same submission
K152178 also covers:
- Freedom System Accessories — Curonix
- Freedom System Accessories — Curonix
- Freedom System Accessories — Curonix
- Freedom System Accessories — Curonix
- Freedom System Accessories — Curonix
- Freedom System Accessories — Curonix
- PN Wearable Accessory L/XL Horizontal — Curonix
- PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel B — Curonix
- PNS Freedom Permanent Tined Neurostimulator Spare Kit Channel A — Curonix
- PNS Freedom Permanent Tined Neurostimulator Spare Kit Channel B — Curonix
- PNS Freedom-4A Permanent Neurostimulator Receiver Kit Channel A — Curonix
- PNS Freedom-4A Permanent Neurostimulator Receiver Kit Channel B — Curonix
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
- Curonix
Sources (1)
- FDA UDI 6fcb8bf2-9f43-435c-b666-53de06d864d4 34 fields · synced Jun 8, 2026