Support, Arm
An Arm Support is an orthotic or assistive device used in Physical Medicine to provide external support to the upper limb, reducing gravitational and mechanical loads on weakened, painful, or injured shoulder, elbow, or arm structures, used during rehabilitation or for chronic upper limb conditions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IOY, regulated under 21 CFR 890.3475, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
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Basic Information
- Product Code
- IOY
- Device Class
- FDA class 1
- Regulation Number
- 890.3475
- 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 |
|---|---|---|---|---|
| K770065 | ADJUSTABLE ARM SUPPORT | Feb 02, 1977 | Substantially Equivalent | Richard F. Kronner, M.D. |
FEI Numbers
This FDA classification entry is associated with 242 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 242 registration numbers. Click on an entry to view related FDA registrations.