Atlas FDA

QDT

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Shoe With Adjustable Sole Units
Device class
Class I (low risk)
Regulation
21 CFR 890.3475
Medical specialty
Physical Medicine
Flags
GMP exempt
FDA definition
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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RecordFirmDate
AposTherapy System (K182090)Apos Medical Assets , Ltd.2018-11-16

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