Band Or Belt, Pelvic Support
A pelvic support band or belt is an external orthotic device worn around the pelvis to provide stability and support to the pelvic girdle, used in the management of pelvic instability, sacroiliac dysfunction, or as part of prosthetic fitting. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ISR, regulated under 21 CFR 890.3025, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- ISR
- Device Class
- FDA class 1
- Regulation Number
- 890.3025
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- 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 |
|---|---|---|---|---|
| K790179 | GAIR TRAINING BELT | Feb 08, 1979 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 146 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 146 registration numbers. Click on an entry to view related FDA registrations.