sparkbiomedical.comSparrow Ascent
Spark Biomedical, Inc.
Spark Biomedical Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017987352 | 3017987352 | Spark Biomedical Inc. | 1 | N | 2026-01-01 | 7535 W Grand Pkwy S Richmond TX US 77407 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860005396955 | Sparrow Ascent Patient Controller - 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. | 832-460-5539 | brent.croft@sparkbiomedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 287837 | 1511603356 | K251246 | Sparrow Ascent | PZR | 2025-08-25 |
| 287837 | 1916397882 | K230796 | Sparrow Ascent | PZR | 2023-06-20 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PZR | 2 | 2025-08-25 |
PMN#
Sparrow Therapy System
Spark Biomedical, Inc.
GUDID#
Sparrow Ascent - Sparrow Ascent Kit - B2C (Mastoid Left 7)
2026-02-02
Sparrow Ascent Kit (B2B) - 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).
2023-09-07
Sparrow Ascent Cable - The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip(model 610) without constricting mobility. A built-in retention clip allows the user to clip the Cable to their clothing to relieve cable strain.This is a subcomponent and is not transacted. See 810-P.
2023-09-07
Sparrow Ascent Earpiece, Left - 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.
2023-09-07
Sparrow Ascent Patient Controller - 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.
2023-09-07
Sparrow Ascent Kit (B2C) - 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).
2023-09-07
Sparrow Ascent 28 Piece Kit (B2C) - A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®). This pack includes the Sparrow Ascent Kit and three Sparrow Ascent Left Earpiece Kits. (1) GTIN: 00860005396986 (Base kit containing the Patient Controller, Cable, Belt Clip, QSG, Batteries, seven Alcohol Wipes, and seven Left Earpieces) (3) GTIN: 00860005396993
2023-09-07
Sparrow Ascent 28 Piece Kit (B2B) - A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®). This pack includes the Sparrow Ascent Kit and three Sparrow Ascent Left Earpiece Kits. (1) GTIN: 00860005396986 (Base kit containing the Patient Controller, Cable, Belt Clip, QSG, Batteries, seven Alcohol Wipes, and seven Left Earpieces) (3) GTIN: 00860005396993
2023-09-07
Sparrow Ascent Cable - The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip(model 610) without constricting mobility. A built-in retention clip allows the user to clip the Cable to their clothing to relieve cable strain.
2023-09-07
Sparrow Ascent Replacement Kit - Separate item for replacement.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.
2023-09-07
Sparrow Ascent Earpiece, Right - 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.
2023-09-07