Sling, Overhead Suspension, Wheelchair
A Wheelchair Overhead Suspension Sling is a positioning accessory that supports the user's arm from an overhead suspension system mounted on the wheelchair frame, used in Physical Medicine to reduce gravitational load on a weakened upper extremity and enable functional arm movement during seated activities. 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 INE, regulated under 21 CFR 890.3910, 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
- INE
- Device Class
- FDA class 1
- Regulation Number
- 890.3910
- 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 |
|---|---|---|---|---|
| K884787 | ACCULITE-PPL 5 | Jan 24, 1989 | Substantially Equivalent | Medical Alignment Systems |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.