Belt, Pelvic, Traction
A pelvic traction belt is an orthopedic device applied around the pelvis to provide traction to the lumbar spine and pelvis, used in the management of lower back pain and certain spinal conditions. It is classified as an FDA Class 1 device under 21 CFR 888.5890, indicating minimal risk subject to general controls. Product code HSQ falls under the Orthopedic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- HSQ
- Device Class
- FDA class 1
- Regulation Number
- 888.5890
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
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 |
|---|---|---|---|---|
| K761036 | WILSON SPINAL FRAME | Dec 16, 1976 | Substantially Equivalent | Orthopedic Equipment Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.