NRV · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6300
Classification
FDA Product Code
NRV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6300
Review panel
HO
Medical specialty
General Hospital
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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