MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)— 510(k) K201257

Substantially Equivalent

Arrive Systems, Inc.

FDA 510(k) clearance K201257 for MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400), Substantially Equivalent on 2021-04-06. Applicant: Arrive Systems, Inc.. Device class: 2.

Clearance details

Applicant
Arrive Systems, Inc.
Product code
Code NGX
Device class
Class 2
Regulation
21 CFR 890.5850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New Ark, DE, US
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