Atalante— 510(k) K221859

Substantially Equivalent

Wandercraft SAS

FDA 510(k) clearance K221859 for Atalante, Substantially Equivalent on 2022-12-29. Applicant: Wandercraft SAS. Device class: 2.

Clearance details

Applicant: Wandercraft SAS
Product code: Code PHL
Device class: Class 2
Regulation: 21 CFR 890.3480
Advisory panel: Physical Medicine
Date received: 2022-06-27
Decision date: 2022-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHL

K254198 — Trexo Theo2026-09-02
K260381 — Eve2026-08-03
K250904 — Atalante X2025-10-24
K241822 — ReWalk® 7 Personal Exoskeleton (50-20-0005)2025-03-12
K233695 — Medical HAL Lower Limb Type (HAL-ML)2024-05-07

More clearances from Wandercraft SAS

K232077 — Atalante X2023-12-13

Recalls naming K221859

K-number listed on FDA's recall record

Z-1739-2025 — Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.Class II·Ongoing·WANDERCRAFT SAS·20250403

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221859.

Data sourced from openFDA. This site is unofficial and independent of the FDA.