QQC — Brain Stimulation Programming Planning Software. Class II

FDA Device Classification

Classification Details

Product Code: QQC
Device Class: Class II
Regulation Number: 882.5855
Submission Type
Review Panel: NE
Medical Specialty: Neurology
Implant: No

Definition

The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K243520	turing medical technologies	Bullsai Confirm	March 28, 2025
K213930	brainlab	Brainlab Elements Guide XT, Guide 3.0	April 19, 2022
DEN210003	medtronic neuromodulation	SureTune4 Software	August 23, 2021