Lido V-Tak

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K924512 ↗

FDA Product Code

LXJ

Device Class

Class II

Regulation

21 CFR Part 890.5360

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Lido Lift

  Class II

  FDA 510(k) K880017 Active Cleared 26 Feb 1988

• Lido Linea

  Class II

  FDA 510(k) K903429 Active Cleared 14 Aug 1990

• Lido Active

  Class II

  FDA 510(k) K871793 Active Cleared 5 Jun 1987

• Lido(Tm) Workset

  Class II

  FDA 510(k) K880018 Active Cleared 26 Feb 1988

• Lido(R) Linea

  Class I

  FDA 510(k) K924513 Active Cleared 31 Mar 1993

• Lido Back

  Class II

  FDA 510(k) K861986 Active Cleared 2 Jun 1986

See all devices from Loredan Biomedical, Inc. →

• What is the Lido V-Tak used for in physical therapy?

  The Lido V-Tak is designed for structured, computer-assisted exercise programs to support muscle conditioning, joint mobility, and functional recovery. It delivers targeted therapeutic interventions under physical medicine supervision, helping patients regain strength and movement safely during rehabilitation.

• Is the Lido V-Tak a single-use or reusable device?

  The Lido V-Tak is a reusable medical device, intended for use in both clinical and home-based physical therapy settings. Proper maintenance per manufacturer guidelines is required to ensure safe and effective operation over multiple patient sessions.

• Does the Lido V-Tak require sterilization before use?

  No, the Lido V-Tak is not a sterile device. It is designed for non-sterile applications in physical therapy, where structured exercise and resistance training are the primary focus rather than sterile procedures.

• What regulatory pathway was used for FDA clearance of the Lido V-Tak?

  The Lido V-Tak received FDA clearance through the Traditional 510(k) pathway (K924512), demonstrating substantial equivalence to a predicate device under FDA regulation 890.5360. It is classified as an Interactive Rehabilitation Exercise Device and authorized for physical medicine applications.

• Where can the Lido V-Tak be used, and what settings are approved?

  The Lido V-Tak is approved for use in clinical physical therapy settings as well as home-based rehabilitation programs. Its design supports supervised exercise therapy, making it versatile for both professional and patient-led recovery environments under medical guidance.