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StimQ Freedom-8A Receiver Kit Channel A US w/ Receiver
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- StimQ Freedom-8A Receiver Kit Channel A US w/ Receiver FDA UDI
- Generic Name
- Analgesic implantable peripheral nerve electrical stimulation system FDA UDI
- Device Name
- StimQ Freedom-8A Receiver Kit Channel A US w/ Receiver StimQ Peripheral Nerve Stimulator System FDA UDI
- Model / Reference
- FR8A-RCV-A0 FDA UDI
- Description
- StimQ Freedom-8A Receiver Kit Channel A US w/ Receiver StimQ Peripheral Nerve Stimulator System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818225020815 FDA UDI
- 510(k) Number
- K171366 FDA UDI
- FDA Product Code
- GZF FDA UDI
- GMDN Term
- Analgesic implantable peripheral nerve electrical stimulation system 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.25 Gram FDA UDILength — 45 Centimeter FDA UDIOuter Diameter — 1.35 Millimeter FDA UDI
Category: Analgesic implantable peripheral nerve electrical stimulation system
StimQ Freedom-8A Receiver Kit Channel A US w/ Receiver by Stimwave Technologies Incorporated — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Analgesic implantable peripheral nerve electrical stimulation system.
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Nalu Medical, Inc. — NALU MEDICAL · Class II
Cleared under the same submission
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 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
- StimQ Freedom-8A Trial Kit Channel A 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 |
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Manufacturer
- Manufacturer
- Stimwave Technologies Incorporated
Sources (1)
- FDA UDI 1c750b92-ded2-41d1-878f-7f7156e82e9d 36 fields · synced May 30, 2026