Identity
- Trade Name
- Freedom System Accessories FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
- Device Name
- Torso Wearable XL FDA UDI
- Model / Reference
- 00-52016 FDA UDI
- Description
- Torso Wearable XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850051034505 FDA UDI
- 510(k) Number
- K182720 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Freedom System Accessories 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.
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Cleared under the same submission
K182720 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
- Freedom System Accessories — Curonix
- Freedom System Accessories — Curonix
- Freedom System Accessories — Curonix
- SCS Freedom-4A Permanent Neurostimulator Receiver Kit Channel A — Curonix
- SCS Freedom-4A Permanent Neurostimulator Receiver Kit Channel B — Curonix
- SCS Freedom-4A Permanent Neurostimulator Spare Kit Channel A — 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 |
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Manufacturer
- Manufacturer
- Curonix
Sources (1)
- FDA UDI 081319d1-ca48-4fa6-90a4-f3f289d30638 34 fields · synced May 30, 2026