Support, Head And Trunk, Wheelchair
A Wheelchair Head and Trunk Support is a positioning accessory attached to a wheelchair to provide support and stabilization to the head and trunk of users who lack sufficient postural control, used in Physical Medicine for individuals with neurological conditions, cerebral palsy, or severe neuromuscular disorders. 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 IMS, 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
- IMS
- Device Class
- FDA class 1
- Regulation Number
- 890.3910
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.