FDA Registration
Active
🇺🇸 United States
RONAN MEDICAL LLC
Reg #: 3015497638
·
FEI: 3015497638
·
Expires 2026
Products
1
Proprietary Names
24
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RONAN MEDICAL LLC
- Registration Number
- 3015497638
- FEI Number
- 3015497638
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3630 Sinton Road, Suite 100
- City
- Colorado Springs
- State
- CO
- ZIP
- 80907
- Country
- US
Owner / Operator
- Firm Name
- Ronan Medical
- Operator Number
- 10060568
- Address
- 3630 Sinton Road, Suite 100
- City
- Colorado Springs
- State
- CO
- Postal Code
- 80907
- Country
- US
- Correspondent
- Doug E Youngberg
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2019-05-28 |
Proprietary Names
FlexiCAP
TruScan Neurofeedback optical cable V3.3L
Recording Cap G1
TruScan Neurofeedback Acquisition
Body Harness
Splitter
Cable for connection
TruScan Neurofeedback Explorer
Quick Insert Electrode
Disc Electrode 9mm Sn (Tin)
Deymed Li-ion Battery
FlexiCAP electrode ring - rubber
Headbox Safety Ribbon Cable for Cap Connection
Pair of Ear Electrodes Sn (Tin)
Disposable blunted needles
Wrist Band Electrode Sn(Tin)
Set for the application of EEG recording gel
TruScan Neurofeedback Adapter
Ear Electrode Sn (Tin)
EEG cap strap
TruScan LT 32 Neurofeedback headbox
TruScan Neurofeedback 32ch
TruScan Neurofeedback 24ch
TruScan LT 24 Neurofeedback headbox
Establishment Types
Complaint File Establishment per 21 CFR 820.198