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
ISDClass II

Exerciser, Measuring

21 CFR 890.5360 / Physical Medicine
FDA source (opens on fda.gov)

ISD is the FDA product code for Exerciser, Measuring, a class II device type, regulated under 21 CFR 890.5360. As of , FDA records hold 61 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
ISD
Device name
Exerciser, Measuring
Regulation
21 CFR 890.5360
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
61
Ingested recalls
2

Clearances, product code ISD

By decision year
61 clearances under product code ISD with a decision year between 1977 and 2020, 1994 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code ISD by decision year
YearClearances
19773
19781
19795
19805
19832
19842
19854
19862
19873
19882
19892
19916
19923
19932
19948
19951
19962
19992
20061
20081
20121
20151
20191
20201

Applicants with the most clearances

Product code ISD
Applicants holding the most 510(k) clearances under product code ISD
ApplicantClearances
Henley Intl.4
Quinton, Inc.4
Tri-Tech, Inc.4
Biodan Medical Systems, Ltd.3
Stanford Scientific, Inc.3
Battle Creek Equipment2
Engineering Dynamics Corp.2
Ergoline GmbH2
Penny and Giles Biometrics, Ltd.2
Th Charters, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 72 companies shown, in name order