510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
IMCClass II

Bath, Paraffin

21 CFR 890.5110 / Physical Medicine
FDA source (opens on fda.gov)

IMC is the FDA product code for Bath, Paraffin, a class II device type, regulated under 21 CFR 890.5110. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IMC
Device name
Bath, Paraffin
Regulation
21 CFR 890.5110
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code IMC

By decision year
12 clearances under product code IMC with a decision year between 1977 and 2009, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IMC by decision year
YearClearances
19771
19831
19841
19862
19981
19991
20001
20011
20022
20091

Applicants with the most clearances

Product code IMC
Applicants holding the most 510(k) clearances under product code IMC
ApplicantClearances
Tri W-G, Inc.2
Bernlit Enterprises, Inc.1
Chattanooga Group, Inc.1
Divi Intl. Co.1
Global TV Concepts, Ltd.1
Grimm Scientific Industries, Inc.1
FKA Distributing Co., LLC1
Raymond Industrial, Ltd.1
Remington Products Company LLC1
Shenzhen Comfort Technology Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code