Definition: Assist A Patient To Visualize The Image And Condition Of The Soles Of Their Feet In Connection With A Daily Self-examination For Signs Of Inflammation On The Sole Of The Foot. The Device Will Assist The Patient In Determining When They Should Contact
| Device Type ID | 2801 |
| Device Name | Foot Examination Tool For Inflammatory Changes |
| Physical State | N/a |
| Technical Method | A Device That Consists Of A 2X Convex Mirror, Surrounded On Two Sides By Liquid Crystal Pads. These Liquid Crystal Pads React To Skin Temperature When The Patient Places His Feet On Top Of Them, Providing Different Colors For Different Temperatures. |
| Target Area | Feet |
| Regulation Description | Daily Activity Assist Device. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.5050 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OIZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2801 |
| Device | Foot Examination Tool For Inflammatory Changes |
| Product Code | OIZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Daily Activity Assist Device. |
| CFR Regulation Number | 890.5050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PODIMETRICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |