NJB — Orthosis, Truncal, For Dysmenorrhea Class I
FDA product code NJB covers "Orthosis, Truncal, For Dysmenorrhea", a Class I medical device regulated under 21 CFR 890.3490. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NJB
- Device Class
- Class I
- Regulation Number
- 890.3490
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K003128 | jm kohn | MODIFICATION TO RELIEF BRIEF | August 12, 2002 |