Orthosis, Truncal, Pregnancy
The Pregnancy Truncal Orthosis is a supportive garment device intended to provide abdominal and back support to pregnant individuals, helping to alleviate musculoskeletal discomfort associated with the physical changes of pregnancy. It is a non-invasive, wearable physical medicine device. Classified as FDA Class 1 under regulation 890.3490, it is subject only to general controls and is exempt from 510(k) premarket notification requirements, under the Physical Medicine specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QSB
- Device Class
- FDA class 1
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
Definition
Provide abdominal and back support during pregnancy
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 |
|---|---|---|---|---|
| K821836 | PREGNANCY (W) EDGE | Jul 30, 1982 | Substantially Equivalent | Body Therapeutics, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.