Identity
- Trade Name
- Stimwave Freedom Spinal Cord Stimulation System FDA UDI
- Generic Name
- Personal device holder, reusable FDA UDI
- Device Name
- Torso Belt Size M Assembly FDA UDI
- Model / Reference
- 00-52014 FDA UDI
- Description
- Torso Belt Size M Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818225022055 FDA UDI
- 510(k) Number
- K182720 FDA UDI
- FDA Product Code
- GZB FDA UDI
- GMDN Term
- Personal device holder, reusable 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
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
Category: Personal device holder, reusable
Stimwave Freedom Spinal Cord Stimulation 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
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
- Freedom System Accessories — Curonix
- SCS Freedom-4A Permanent Neurostimulator Receiver Kit Channel A — Curonix
- SCS 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 |
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Manufacturer
- Manufacturer
- Stimwave Technologies Incorporated
Sources (1)
- FDA UDI 7d58a1ea-5194-4f34-8e01-483c74acbf05 34 fields · synced May 31, 2026