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

Orthosis, Truncal, For Dysmenorrhea

21 CFR 890.3490 / Physical Medicine
FDA source (opens on fda.gov)

NJB is the FDA product code for Orthosis, Truncal, For Dysmenorrhea, a class I device type, regulated under 21 CFR 890.3490. FDA's definition for this code reads: "A truncal orthosis for dysmenorrhea is a device intended to provide pressure to acupressure points on the lower abdomen and lower back for the purpose of reducing menstrual pain symptoms including cramps, abdominal pain and backache". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NJB
Device name
Orthosis, Truncal, For Dysmenorrhea
FDA definition
A truncal orthosis for dysmenorrhea is a device intended to provide pressure to acupressure points on the lower abdomen and lower back for the purpose of reducing menstrual pain symptoms including cramps, abdominal pain and backache.
Regulation
21 CFR 890.3490
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
1
Ingested recalls
0

Clearances, product code NJB

By decision year
1 clearance under product code NJB with a decision year between 2002 and 2002, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NJB by decision year
YearClearances
20021

Applicants with the most clearances

Product code NJB
Applicants holding the most 510(k) clearances under product code NJB
ApplicantClearances
The JM Kohn Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order