SAFE-STEP
Device Facts
| Record ID | K931517 |
|---|---|
| Device Name | SAFE-STEP |
| Applicant | Lenjoy Engineering, Inc. |
| Product Code | IRN · Physical Medicine |
| Decision Date | Mar 10, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5575 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.
Special Controls
*Classification.* Class II (special 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.
