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

Dynamometer, Ac-Powered

21 CFR 888.1240 / Orthopedic
FDA source (opens on fda.gov)

LBB is the FDA product code for Dynamometer, Ac-Powered, a class II device type, regulated under 21 CFR 888.1240. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LBB
Device name
Dynamometer, Ac-Powered
Regulation
21 CFR 888.1240
Device class
Class II
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
36
Ingested recalls
2

Clearances, product code LBB

By decision year
36 clearances under product code LBB with a decision year between 1981 and 2017, 1991 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code LBB by decision year
YearClearances
19812
19851
19861
19883
19891
19901
19917
19926
19933
19942
19972
19982
20011
20041
20051
20081
20171

Applicants with the most clearances

Product code LBB
Applicants holding the most 510(k) clearances under product code LBB
ApplicantClearances
Nk Biotechnical Engineering Co.10
Chattanooga Group, Inc.4
John Chatillon & Sons, Inc.3
Greenleaf Medical Systems, Inc.2
Ametek, Inc.1
Dynatronics Laser Corp.1
Equipement Biomedical Specialise, Inc.1
Exos Medical Products1
Exos, Inc.1
Global Services Group, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order