510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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IMGClass II

Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

21 CFR 890.5860 / Physical Medicine
FDA source (opens on fda.gov)

IMG is the FDA product code for Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, a class II device type, regulated under 21 CFR 890.5860. As of , FDA records hold 55 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
IMG
Device name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5860
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
55
Ingested recalls
2

Clearances, product code IMG

By decision year
55 clearances under product code IMG with a decision year between 1977 and 2025, 1994 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code IMG by decision year
YearClearances
19771
19781
19811
19821
19842
19861
19872
19882
19904
19911
19921
19935
19948
19952
19981
19991
20001
20021
20033
20042
20051
20073
20101
20113
20122
20152
20161
20251

Applicants with the most clearances

Product code IMG
Applicants holding the most 510(k) clearances under product code IMG
ApplicantClearances
Chattanooga Group, Inc.13
Mettler Electronics Corp6
Rich-Mar Corp.5
Excel Tech., Ltd.3
Henley Intl.3
Shenzhen Dongdixin Technology Co., Ltd.3
Alfa Tech Medical Systems, Ltd.2
Dynatronics Corp.2
Metron Medical Australia, Pty, Ltd.2
Physio Technology, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order