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

Bath, Sitz, Nonpowered

21 CFR 890.5125 / Physical Medicine
FDA source (opens on fda.gov)

KTC is the FDA product code for Bath, Sitz, Nonpowered, a class I device type, regulated under 21 CFR 890.5125. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KTC
Device name
Bath, Sitz, Nonpowered
Regulation
21 CFR 890.5125
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code KTC

By decision year
7 clearances under product code KTC with a decision year between 1980 and 1991, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KTC by decision year
YearClearances
19801
19831
19841
19851
19861
19891
19911

Applicants with the most clearances

Product code KTC
Applicants holding the most 510(k) clearances under product code KTC
ApplicantClearances
Abco Dealers, Inc.1
Drummond Industries, Inc.1
Lsl Industries, Inc.1
Mac Lee Medical Products1
The Healthcare Group Laboratories, Inc.1
The Spritz Co.1
W. C. Green, D.D.S.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 48 companies shown, in name order