510(k) K182090
K182090 is an FDA 510(k) premarket notification submitted by Apos Medical Assets , Ltd. for the device "AposTherapy System". The FDA issued a decision of Substantially Equivalent on November 16, 2018. The device falls under product code QDT (Shoe With Adjustable Sole Units), a Class I device regulated under 21 CFR 890.3475.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2018
- Date Received
- August 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shoe With Adjustable Sole Units
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type
Intended to adjust the foots points of contact with the ground to affect the distribution of weight/force(s) applied to a lower limb