Shoe With Adjustable Sole Units
The Shoe With Adjustable Sole Units is a medical footwear device intended to adjust the foot's points of contact with the ground to affect the distribution of weight and forces applied to a lower limb, used in physical medicine and rehabilitation. It is classified as FDA Class 1, subject to general controls and exempt from premarket notification, under regulation 890.3475 in the Physical Medicine specialty. The product code is QDT. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDT
- Device Class
- FDA class 1
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
Definition
Intended to adjust the foots points of contact with the ground to affect the distribution of weight/force(s) applied to a lower limb
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 |
|---|---|---|---|---|
| K182090 | AposTherapy System | Nov 16, 2018 | Substantially Equivalent | Apos Medical Assets , Ltd. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.