FDA 510(k)

Phoenix

K-Number: K183152 · 2019-04-17

Decision Date2019-04-17

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Phoenix is the device name listed in this FDA 510(k) record. The listed applicant is Us Bionics, Inc. (Dba Suitx). It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K183152. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phoenix?

Phoenix is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Us Bionics, Inc. (Dba Suitx). The 510(k) number is K183152.

When did Phoenix receive FDA 510(k) clearance?

Phoenix received FDA 510(k) clearance on 2019-04-17, under 510(k) number K183152.

Who is the listed applicant for Phoenix?

The FDA 510(k) record lists Us Bionics, Inc. (Dba Suitx) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phoenix?

The FDA product code for Phoenix is PHL.

Related Devices (Code: PHL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260381EveWandercraft SAS K250904Atalante XWandercraft SAS K241822ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba Lifeward K233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.K232077Atalante XWandercraft SAS K221696ReWalk P6.0Re Walk Robotics , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.