510(k) K003128
K003128 is an FDA 510(k) premarket notification submitted by The JM Kohn Co. for the device "MODIFICATION TO RELIEF BRIEF". The FDA issued a decision of Substantially Equivalent on August 12, 2002. The device falls under product code NJB (Orthosis, Truncal, For Dysmenorrhea), a Class I device regulated under 21 CFR 890.3490.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2002
- Date Received
- October 6, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Truncal, For Dysmenorrhea
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type
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.