Orthosis, Truncal, For Dysmenorrhea
The Truncal Orthosis for Dysmenorrhea is a physical medicine device that provides 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. It is classified as FDA Class 1 (General Controls), with GMP exemption applicable (GMP exempt flag Y), under product code NJB and regulation 21 CFR 890.3490 in the Physical Medicine specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- NJB
- Device Class
- FDA class 1
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K003128 | MODIFICATION TO RELIEF BRIEF | Aug 12, 2002 | Substantially Equivalent | The JM Kohn Co. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.