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510(k) K183152

Phoenix by Us Bionics, Inc. (Dba Suitx) — Product Code PHL

K183152 is an FDA 510(k) premarket notification submitted by Us Bionics, Inc. (Dba Suitx) for the device "Phoenix". The FDA issued a decision of Substantially Equivalent on April 17, 2019. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2019
Date Received
November 14, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Exoskeleton
Device Class
Class II
Regulation Number
890.3480
Review Panel
NE
Submission Type

A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.

Other clearances for product code PHL

  • K250904 — Atalante X (October 24, 2025)
  • K241822 — ReWalk® 7 Personal Exoskeleton (50-20-0005) (March 12, 2025)
  • K233695 — Medical HAL Lower Limb Type (HAL-ML) (May 7, 2024)
  • K232077 — Atalante X (December 13, 2023)
  • K221696 — ReWalk P6.0 (March 2, 2023)
  • K221859 — Atalante (December 29, 2022)
  • K220988 — EksoNR (June 9, 2022)
  • K213452 — GEMS-H (April 21, 2022)
  • K201473 — ExoAtlet-II (July 16, 2021)
  • K201559 — HAL for Medical Use(Lower Limb type) (October 2, 2020)

FDA data resources