Orpyx SI sensory insoles are custom insoles embedded with powered limb overload warning technology intended for monitoring physiologic parameters, including plantar pressure and…
Orpyx SI sensory insoles are custom insoles embedded with powered limb overload warning technology intended for monitoring physiologic parameters, including plantar pressure and temperature. It provides the user with real-time, individualized cues for pressure offloading. it is intended to act as an adjunct to standard foot care, not a replacement.
Who Else Makes It
Concentrated in Shanghai (2), Henan (2), Guangdong (2).
Record
Regulatory record for Orpyx SI sensory insoles | Listed by | Orpyx Medical Technologies Inc., Canada |
| FDA product code | MNE |
| Device type | Orthosis, Moldable, Supportive, Skin Protective |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-12-17 |
| Record revised | 2023-11-03 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2020-03-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.