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
K003128Substantially Equivalent

Modification to Relief Brief

The JM Kohn Co., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003128 is the FDA 510(k) clearance record for MODIFICATION TO RELIEF BRIEF, a class I device, cleared for The JM Kohn Co. on under FDA product code NJB (Orthosis, Truncal, For Dysmenorrhea). FDA's definition for product code NJB 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". FDA records list one 510(k) clearance for The JM Kohn Co. As of , FDA records show no recalls naming K003128.

Clearance record

Decision date
Received
(675 days to decision)
Product code
NJB Orthosis, Truncal, For Dysmenorrhea
Regulation
21 CFR 890.3490
Device class
Class I
Review panel
Physical Medicine
Applicant
The JM Kohn Co. 201 Spear St., San Francisco CA
510(k) summary
Summary
Third party review
No

Clearances, product code NJB

Trailing 12 months

FDA records hold no clearances under product code NJB in the trailing twelve months.

FDA records show no clearances under product code NJB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NJB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260