Lido Lift
510(k) K880017
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880017 | Date26 Feb 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Lido(Tm) Lift
- 510(k) Number
- FDA Product Code
- IKK
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.1925
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Lido Lift is a System, Isokinetic Testing and Evaluation device designed for physical medicine applications. It provides controlled, measurable resistance for assessing and improving muscle strength, endurance, and joint mobility through isokinetic exercise protocols. The system is engineered to deliver precise torque and angular velocity adjustments, enabling clinicians to evaluate and rehabilitate patients with musculoskeletal conditions.
This device is intended for use in clinical settings such as physical therapy offices, rehabilitation centers, and sports medicine facilities. Supplied as a reusable medical system, it requires proper maintenance and calibration to ensure accuracy and safety. The Lido Lift is classified as a Class II device under FDA regulations, with an FDA 510(k) clearance (K880017). It operates within standard electromagnetic interference (EMI) limits and is not intended for use in MRI environments. Storage and handling follow standard medical equipment protocols to preserve functionality and hygiene.
Other devices from Loredan Biomedical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Lido Lift used for in clinical settings?
The Lido Lift is designed for physical medicine applications, specifically to assess and improve muscle strength, endurance, and joint mobility through controlled, measurable resistance. Clinicians use it to evaluate and rehabilitate patients with musculoskeletal conditions by applying precise torque and angular velocity adjustments during isokinetic exercise protocols.
Is the Lido Lift a single-use or reusable device?
The Lido Lift is a reusable medical system. It requires regular maintenance and calibration to ensure accuracy, safety, and functionality over repeated use. Proper cleaning and upkeep are essential to preserve its performance and hygiene standards in clinical environments.
Where can the Lido Lift be used, and what environments should it avoid?
The Lido Lift is intended for use in clinical settings such as physical therapy offices, rehabilitation centers, and sports medicine facilities. It is not designed for use in MRI environments due to electromagnetic interference (EMI) limitations. Standard medical equipment protocols should be followed for storage and handling to maintain its functionality.
What regulatory approval does the Lido Lift hold?
The Lido Lift holds FDA 510(k) clearance (K880017) and is classified as a Class II device under FDA regulations. This clearance indicates that the device is considered substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness in its intended use.
How does the Lido Lift ensure accurate and safe performance?
The Lido Lift delivers precise torque and angular velocity adjustments, which are critical for accurate assessment and rehabilitation of patients. To maintain this precision, the device requires routine maintenance and calibration as part of its operational protocol. This ensures consistent performance, safety, and reliability in clinical applications.