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Shoe With Adjustable Sole Units

FDA product code QDT · 1 cleared devices

Class 1 Physical Medicine
Regulation
21 CFR 890.3475
Review panel
PM
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
Yes
Clearance span
2018-11-16 – 2018-11-16

Intended to adjust the foot’s points of contact with the ground to affect the distribution of weight/force(s) applied to a lower limb

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