DeviceClearance

Product code MVA— Neurology

CRANIAL HELMET

Classification name
Orthosis, Cranial
Device class
Class 2
Regulation
21 CFR 882.5970
Advisory panel
Neurology
Total cleared
43
First cleared
Most recent

Market context for product code MVA

FDA has cleared 43 devices under product code MVA between 1998 and 2024, filed by 32 applicant companies. 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.

Clearances per year

last 15 years

Top applicants under product code MVA

Recent clearances under product code MVA

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