Identity
- Trade Name
- Sparrow Ascent Earpiece, Right FDA UDI
- Generic Name
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI
- Device Name
- The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity. The Inner Electrode interfaces with the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the return Electrode for both the Inner and Outer Electrodes. FDA UDI
- Model / Reference
- 211 FDA UDI
- Description
- The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity. The Inner Electrode interfaces with the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the return Electrode for both the Inner and Outer Electrodes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850052017019 FDA UDI
- 510(k) Number
- K230796 FDA UDI
- FDA Product Code
- PZR FDA UDI
- GMDN Term
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5896 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Sparrow Ascent Earpiece, Right by Spark Biomedical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator.
- OpiRelief — DYANSYS INDIA PRIVATE LIMITED · Class II
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- Morph Device — DYANSYS INDIA PRIVATE LIMITED · Class II
- NSS-2 Bridge — NEURAXIS, INC · Class II
- NSS IB-STIM — NEURAXIS, INC · Class II
- Sparrow Ascent Cable — Spark Biomedical Inc. · Class II
Cleared under the same submission
K230796 also covers:
- Sparrow Ascent 28 Piece Kit (B2B) — Spark Biomedical Inc.
- Sparrow Ascent 28 Piece Kit (B2C) — Spark Biomedical Inc.
- Sparrow Ascent Cable — Spark Biomedical Inc.
- Sparrow Ascent Cable — Spark Biomedical Inc.
- Sparrow Ascent Earpiece, Left — Spark Biomedical Inc.
- Sparrow Ascent Patient Controller — Spark Biomedical Inc.
- Sparrow Ascent Replacement Kit — Spark Biomedical Inc.
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
- Spark Biomedical Inc.
Sources (1)
- FDA UDI b8c0b73b-c4ba-4708-ba4c-fb6871f63048 35 fields · synced May 30, 2026