IME

Pack, Hot Or Cold, Reusable

Product code
IME
Device name
Pack, Hot Or Cold, Reusable
Device class
Class 1
21 CFR
21 CFR 890.5700
Medical specialty
Physical Medicine
Marketing pathway
510(K) Exempt
Flag
GMP exempt
510(k) clearances (all years, FDA)
27 (all years; only the last 3 years are listed here)
Official FDA classification page: IME
Classification and pathway per current FDA publications. Data from openFDA (CC0).