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

Exerciser, Powered

21 CFR 890.5380 / Physical Medicine
FDA source (opens on fda.gov)

BXB is the FDA product code for Exerciser, Powered, a class I device type, regulated under 21 CFR 890.5380. As of , FDA records hold 160 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
BXB
Device name
Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
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
160
Ingested recalls
6

Clearances, product code BXB

By decision year
160 clearances under product code BXB with a decision year between 1980 and 2008, 1994 the highest year at 21.
Show the numbers
510(k) clearances under FDA product code BXB by decision year
YearClearances
19801
19811
19826
19838
198416
198512
19866
19878
19887
19899
19909
199111
199213
199312
199421
199516
19962
20011
20081

Applicants with the most clearances

Product code BXB
Applicants holding the most 510(k) clearances under product code BXB
ApplicantClearances
Allied Associates, Inc.9
Toronto Medical Corp.9
Buckman Co., Inc.8
Invacare GmbH8
Sutter Corp.5
Dyna Flex, Intl.4
Sutter Biomedical, Inc.4
Baltimore Therapeutic Equipment Co.3
Sport Medical Technology Inc3
Danninger Medical Technology, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 115 companies shown, in name order