Eve
By Wandercraft
FDA-cleared powered self-balancing personal exoskeleton commercially launched in the United States in September 2026 through a prescription-based evaluation, fitting and training pathway.
Product Overview
Eve is Wandercraft’s FDA-cleared powered self-balancing personal exoskeleton for eligible people with spinal cord injury. FDA 510(k) K260381 received a Substantially Equivalent decision on 3 August 2026, and Wandercraft commercially launched Eve in the United States on 17 September 2026. The U.S. access pathway includes clinical evaluation and trial, physician prescription, custom fitting and manufacturing, personalized training, and delivery and support. National Seating & Mobility is Wandercraft’s exclusive U.S. complex rehabilitation technology distribution partner for Eve. USVetServ supports the VA pathway where applicable. Eligibility and reimbursement depend on clinical, payer and program requirements; FDA clearance does not guarantee coverage.
Positioning & Buyer Fit
FDA-cleared powered self-balancing personal exoskeleton commercially available in the United States for eligible personal mobility users through a prescription-based access pathway.
Relevant for eligible people with spinal cord injury and clinical teams evaluating hands-free upright personal mobility in the United States. Eligibility, prescription and payer requirements apply.
Use Case & Product Classification
Self-balancing personal exoskeleton
- FDA 510(k) K260381 cleared
- self-balancing powered personal exoskeleton
- U.S. prescription-based access
- clinical evaluation/trial
- custom fitting
- personalized training
- NSM exclusive U.S. CRT distribution partner
Product Highlights & Manufacturer Claims
- Powered self-balancing personal exoskeleton
- intended for home and community mobility
- structured clinical evaluation
- custom fitting and personalized training before delivery
Reported performance or product claims
Wandercraft states that Eve is commercially available in the United States for eligible users following FDA 510(k) clearance, through a prescription-based pathway that includes evaluation, fitting, training and support.
These claims are based on manufacturer or public-source information and should be verified with the supplier before purchase, deployment or procurement decisions.
Custom fitted and manufactured following clinical evaluation and prescription, according to Wandercraft’s U.S. access pathway.
United States commercial access is prescription-based. Current pathway includes clinical evaluation/trial, physician prescription, custom fitting/manufacturing, personalized training, and delivery/support. Payer coverage varies and should be confirmed case by case.
FDA 510(k) K260381 received a Substantially Equivalent decision on 3 August 2026. Wandercraft announced U.S. commercial launch on 17 September 2026. National Seating & Mobility is the exclusive U.S. CRT distribution partner for Eve. U.S. VA access is supported through USVetServ where applicable. FDA clearance does not imply automatic reimbursement or universal eligibility.
Certification & Regulatory Notes
FDA-cleared in the United States under 510(k) K260381; Substantially Equivalent decision dated 3 August 2026.
FDA 510(k) K260381 cleared. U.S. commercial access is prescription-based; clearance does not imply automatic reimbursement or universal eligibility.
Pricing & Commercial Access
No official public price found
Pricing Not Public
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