Facility

RONAN MEDICAL LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3015497638
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	3630 Sinton Road Colorado Springs, CO, US 80907
Registration status	Active · expires 2026
Parent company	Ronan Medical (owner-operator 10060568)
Brand names	TruScan Neurofeedback optical cable V3.3L; Cable for connection; TruScan Neurofeedback Adapter; Pair of Ear Electrodes Sn (Tin); TruScan Neurofeedback 24ch; Splitter; TruScan Neurofeedback 32ch; Ear Electrode Sn (Tin); Recording Cap G1; Quick Insert Electrode; TruScan LT 32 Neurofeedback headbox; FlexiCAP electrode ring - rubber

Activity by year

Recalls (1)

Devices registered here (1)

Device, Biofeedback
Product code HCC (opens in a new tab) · Class II · Neurology · 21 CFR 882.5050

Recalls & enforcement

Class IIOngoing2023-12-11
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.

All facilities operated by Ronan Medical

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “RONAN MEDICAL LLC (FEI 3015497638) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015497638-ronan-medical-llc/

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