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Sparrow Ascent Kit (B2B)

FDA UDI

Class II (US FDA UDI)

by Spark Biomedical Inc.

Identity

Trade Name
Sparrow Ascent Kit (B2B) FDA UDI
Generic Name
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI
Device Name
The Sparrow Ascent 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 Sparrow Ascent 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. The Sparrow Ascent is to be used in clinical environments (e.g., doctor’s office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user’s clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG). FDA UDI
Model / Reference
11-320-K FDA UDI
Description
The Sparrow Ascent 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 Sparrow Ascent 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. The Sparrow Ascent is to be used in clinical environments (e.g., doctor’s office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user’s clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG). FDA UDI

Identifiers

Primary DI / UDI-DI
00860005396986 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

Sparrow Ascent Kit (B2B) 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spark Biomedical Inc.

Sources (1)

  • FDA UDI 1c79cd7c-5f81-4155-9ca6-baad0b1859dd 33 fields · synced May 30, 2026