Identity
- Trade Name
- Inspire FDA UDI
- Generic Name
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
- Device Name
- The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG. FDA UDI
- Model / Reference
- 900-008-053 FDA UDI
- Description
- The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG. FDA UDI
Identifiers
- Catalog Number
- 2500 FDA UDI
- Primary DI / UDI-DI
- 00855728005611 FDA UDI
- PMA Number
- P130008 FDA UDI
- FDA Product Code
- MNQ FDA UDI
- GMDN Term
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
Category: Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Inspire by Inspire Medical Systems — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P130008 also covers:
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
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 III | Pending data |
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Manufacturer
- Manufacturer
- Inspire Medical Systems
Sources (1)
- FDA UDI 2ce90364-5b33-4ae5-8b33-dc9dbeed6833 35 fields · synced May 30, 2026