Shoe With Adjustable Sole Units
Device Code: 5245
Product Code(s):
QDT 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
Device Classification Information
| Device Type ID | 5245 |
| Device Name | Shoe With Adjustable Sole Units |
| Physical State | Shoes With Adjustable Convex Units Located Externally On The Bottom Of The Shoe (i.e., Sole) |
| Technical Method | Adjusts The Foot’s Points Of Contact With The Ground To Affect The Distribution Of Weight/force(s) Applied To The Lower Limb. |
| Target Area | Worn On The Feet To Affect The Distribution Of Weight/force(s) Of The Knee Joint |
| Regulation Description | Limb Orthosis. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.3475 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | QDT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5245 |
| Device | Shoe With Adjustable Sole Units |
| Product Code | QDT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Limb Orthosis. |
| CFR Regulation Number | 890.3475 [🔎] |
TPLC Last Update: 2019-04-02 21:02:50