Identity
- Trade Name
- Sparrow Ascent Patient Controller FDA UDI
- Generic Name
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI
- Device Name
- The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. This is a subcomponent and is not transacted. See 11-110-K. FDA UDI
- Model / Reference
- 110 FDA UDI
- Description
- The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. This is a subcomponent and is not transacted. See 11-110-K. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005396955 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Sparrow Ascent Patient Controller 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.
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- NSS-2 Bridge — NEURAXIS, INC · Class II
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- 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 Earpiece, Right — 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 |
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Manufacturer
- Manufacturer
- Spark Biomedical Inc.
Sources (1)
- FDA UDI ebd5f636-c930-4e04-91bf-3df3415c6edb 35 fields · synced May 31, 2026