OIZ · Foot Examination Tool For Inflammatory Changes
Physical Medicine · 21 CFR 890.5050 · Class 1
Overview
| Product Code | OIZ |
|---|---|
| Device Name | Foot Examination Tool For Inflammatory Changes |
| Regulation | 21 CFR 890.5050 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150557 | Podimetrics Remote Temperature Monitoring System | Podimetrics,Inc. | Oct 8, 2015 | SESE |
| K080816 | VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT | Visual Footcare Technologies, LLC | Jun 24, 2008 | SESE |
Top Applicants
- Podimetrics,Inc. — 1 clearance
- Visual Footcare Technologies, LLC — 1 clearance
