DeviceClearance

Product code NRV— General Hospital

VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER

Classification name
Implantable Radio Frequency Transponder System
Device class
Class 2
Regulation
21 CFR 880.6300
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“An implantable microtransponder system intended to facilitate access to identification and health information in humans. It is described as consisting of a small implantable electronic microtransponder, an insertion device (introducer), and an electronic scanner (pocket reader). The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam sent by a handheld, battery-powered pocket reader. The microtransponder stores only a unique electronic identification number (id). The id number is used to access a database that provides the implanted person's identity and health information supplied by the patient”

— U.S. Food and Drug Administration, device classification record for product code NRV under 21 CFR 880.6300, via openFDA

Market context for product code NRV

FDA has cleared 1 device under product code NRV, all in 2004, 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 NRV

Recent clearances under product code NRV

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