FDA product code NJB: Orthosis, Truncal, For Dysmenorrhea
NJB is the FDA product code for orthosis, truncal, for dysmenorrhea. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under NJB. The average 510(k) review took 675 days (median 675).
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.
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Truncal, For Dysmenorrhea |
| Device class | Class I |
| Regulation | 21 CFR 890.3490 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every NJB clearance
Top NJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The JM Kohn Co. | 1 | 2002-08-12 |
Most recent NJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003128 | The JM Kohn Co. | MODIFICATION TO RELIEF BRIEF | 2002-08-12 | 675 |
Recalls for NJB devices
openFDA lists no recalls for product code NJB.
Frequently asked questions
What is FDA product code NJB?
NJB is the FDA product code for orthosis, truncal, for dysmenorrhea. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel.
What device class is NJB?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NJB?
Across 1 cleared submissions the average was 675 days from receipt to decision (median 675).
Which companies have the most NJB clearances?
The JM Kohn Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NJB
- Run a recall and safety report across every NJB manufacturer
- Watch product code NJB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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