FDA 510(k) Premarket Notification K221200: XBody Go USA, XBody Pro USA

Submission Details & Decision

Normalized public record details for 510(k) notification K221200.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K221200

Applicant / Sponsor

Xbody Hungary Kft.

Device Name

XBody Go USA, XBody Pro USA

Product Code

NGX

Decision Date

2023-01-31

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Physical Medicine (PM)

Clearance Type

Traditional

Third Party Flag

Date Received

2022-04-26

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