510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Wandercraft

Paris Ile-de-France, FR

WANDERCRAFT appears in FDA device records in Paris Ile-de-France, FR. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Wandercraft carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Wandercraft SAS510(k), enforcement report, recall

510(k) clearance history

FDA records hold 4 510(k) clearances for Wandercraft between 2022 and 2026. The busiest year on record is 2022, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Wandercraft, by decision year
YearClearances
20221
20231
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260381EvePHLSubstantially Equivalent
K250904Atalante XPHLSubstantially Equivalent
K232077Atalante XPHLSubstantially Equivalent
K221859AtalantePHLSubstantially Equivalent

Registered establishments

FDA registered establishments for Wandercraft, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30150006763015000676WANDERCRAFT23-23 bis avenue d'Italie, Paris Ile-de-France 75013 FR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1739-2025Atalante 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.Potential for exoskeleton to lose lateral balance and cause patient to fall.Class IIOpen, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain