SPEAC System
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Basic Information
- Brand Name
- SPEAC System
- Primary DI
- B481SPC150
- Version / Model
- SPC15
- Company Name
- BRAIN SENTINEL, INC.
- Labeler DUNS
- 969967764
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0474573a-b881-4f23-a4e6-885aacf49253
Device Description
The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| POS | Physiological Signal Based Seizure Monitoring System | Neurology | 882.1580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61288 | Home seizure monitoring system | An assembly of devices intended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings. It typically consists of a mains electricity (AC-powered) central monitor that wirelessly receives, records, and displays the data, and one or more battery-powered body-worn sensor(s); it may have alarms and data may be transmitted to a cloud-based storage, server or mobile device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B481SPC150 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN140033 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 45 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 45 – 85 Percent (%) Relative Humidity