Orthosis, Moldable, Supportive, Skin Protective
The Moldable Supportive Skin-Protective Orthosis is a custom-moldable or prefabricated orthopedic support device applied externally to the body to provide structural support, protect skin integrity, and maintain positioning in patients with musculoskeletal conditions, pressure injuries, or post-surgical needs. Classified as a Class 1 device under 21 CFR 890.3475 within the Physical Medicine specialty, it is subject to general controls only and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MNE
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.