DeviceClearance

Product code SJJ— Cardiovascular

SmartRead(TM) Medical Device Identifier (4100)

Classification name
Cardiac Device Identifier
Device class
Class 2
Regulation
21 CFR 870.3645
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“A cardiac device identifier is a noninvasive device that is intended to provide information about implanted cardiac devices. The device detects and matches telemetry based on manufacturer-specific wireless communication signals, including radiofrequency or inductive signals, to identify an implanted cardiac device, including manufacturer, model, or type. The device is not intended to deliver therapeutic stimulation to, modify the programming of, or manipulate the stored data of the implanted device.”

— U.S. Food and Drug Administration, device classification record for product code SJJ under 21 CFR 870.3645, via openFDA

Market context for product code SJJ

FDA has cleared 1 device under product code SJJ, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SJJ

Recent clearances under product code SJJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.