D88VS Wheelchair Power System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K894346 ↗

FDA Product Code

ITI

Device Class

Class II

Regulation

21 CFR Part 890.3860

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Enabler Lightweight Manual Wheelchair

  Class I

  FDA 510(k) K894345 Active Cleared 27 Jul 1989

• Electro-Lite Power Wheelchair

  Class II

  FDA 510(k) K894344 Active Cleared 28 Jul 1989

• Electro-Lite Elite Powered Wheelchair

  Class II

  FDA 510(k) K970575 Active Cleared 5 Aug 1997

• Is the D88VS Wheelchair Power System intended for single-use or can it be reused?

  The D88VS Wheelchair Power System is designed as a reusable device. Since it is classified as a Class II medical device and supplied non-sterile, it is meant for repeated use in clinical settings, provided proper maintenance and cleaning protocols are followed.

• What types of environments or settings is the D88VS Wheelchair Power System intended for use in?

  The D88VS Wheelchair Power System is regulated under the FDA’s product code ITI and is specifically associated with the Physical Medicine advisory committee. This indicates it is intended for use in physical medicine settings, such as rehabilitation clinics, home healthcare, or other environments where mobility assistance for individuals with limited mobility is provided.

• How is the D88VS Wheelchair Power System regulated by the FDA, and what does that mean for buyers?

  The D88VS Wheelchair Power System holds an FDA 510(k) clearance (K894346) with a decision of Substantially Equivalent, meaning it has been determined to be as safe and effective as a legally marketed device that served as its predicate. This clearance under product code ITI ensures compliance with FDA regulations for powered wheelchairs, providing assurance of its design and performance standards for clinical use.

• Are there any specific storage instructions provided for the D88VS Wheelchair Power System?

  The provided data does not include explicit storage conditions for the D88VS Wheelchair Power System. Since it is a reusable, non-sterile device, buyers should follow general guidelines for maintaining mobility equipment, such as keeping it in a clean, dry environment and protecting it from physical damage or exposure to extreme temperatures.

• Does the D88VS Wheelchair Power System come with multiple models or sizes, and if so, how are they differentiated?

  The data lists multiple FEI numbers (e.g., 3014522447, 3021071770, etc.) associated with the D88VS Wheelchair Power System, which typically represent different models or variations in a product line. While the exact specifications (e.g., weight capacity, wheelbase, or battery type) are not detailed here, these FEI numbers suggest the system may be available in various configurations to accommodate different user needs. Buyers should consult Damaco’s documentation or sales team for precise model comparisons.