NJB
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Orthosis, Truncal, For Dysmenorrhea
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3490
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| MODIFICATION TO RELIEF BRIEF (K003128) | The JM Kohn Co. | 2002-08-12 | + Add |
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