DeviceClearance

Product code IMC— Physical Medicine

MADDATHERM PARAFFIN BATH

Classification name
Bath, Paraffin
Device class
Class 2
Regulation
21 CFR 890.5110
Advisory panel
Physical Medicine
Total cleared
12
First cleared
Most recent

Market context for product code IMC

FDA has cleared 12 devices under product code IMC between 1977 and 2009, filed by 11 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

Top applicants under product code IMC

Recent clearances under product code IMC

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