SmartStep System
by Andante Medical Device, Ltd.
510(k) K023161
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023161 | Date10 Dec 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5575
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SmartStep System is a powered external limb device classified as a Class II medical device under FDA regulations (IRN product code). It is designed for physical medicine applications, specifically to assist in gait analysis and rehabilitation by providing synchronised video and wearable-based monitoring of lower limb movement. This device supports clinical assessments and long-term rehabilitation by integrating real-time data collection and feedback mechanisms for patients with mobility impairments.
The SmartStep System is supplied as a reusable clinical tool intended for use in physical medicine settings, such as rehabilitation clinics or outpatient facilities. It is not sterile and requires proper maintenance per manufacturer guidelines. The system includes MRI-unsafe components and is intended for use with patients under clinical supervision. Authorisation for this device includes FDA 510(k) clearance under the Traditional review pathway, with a clearance date of December 10, 2002 (K023161). Storage and operational conditions must adhere to the manufacturer’s instructions to ensure accurate performance and patient safety.
Questions
AI-generated answers, 1 Oct 2026
What is the SmartStep System used for?
The SmartStep System is designed for physical medicine applications, specifically to assist in gait analysis and rehabilitation. It provides synchronized video and wearable-based monitoring of lower limb movement, enabling real-time data collection and feedback for patients with mobility impairments. This helps clinicians assess progress and tailor treatment plans effectively.
Is the SmartStep System reusable or single-use?
The SmartStep System is supplied as a reusable clinical tool. It is intended for use in settings like rehabilitation clinics or outpatient facilities, where proper maintenance per manufacturer guidelines is required to ensure accurate performance and patient safety.
Does the SmartStep System require sterilization?
No, the SmartStep System is not sterile and is not intended for sterile procedures. It is a reusable device meant for clinical use in non-sterile environments, such as rehabilitation settings. Maintenance should follow the manufacturer’s instructions to uphold safety and functionality.
Are there any MRI safety concerns with the SmartStep System?
Yes, the SmartStep System includes MRI-unsafe components. This means it should not be used in or near MRI environments, as exposure to magnetic fields could pose risks to both the device and patients. Always ensure the device is used in appropriate, non-MRI settings under clinical supervision.
How should the SmartStep System be stored?
The SmartStep System must be stored and operated according to the manufacturer’s instructions to maintain accurate performance and ensure patient safety. Proper storage conditions help preserve functionality and prevent damage, particularly given its reusable nature and non-sterile use in clinical settings.