Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017449291

FEI Number

3017449291

Entity Name

ICARUS MEDICAL LLC

City/State/Country

Charlottesville, VA, US

Establishment Address

609 East Market Street, Ste 114, Charlottesville, VA 22902, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Icarus Medical LLC (Owner Number: 10077807)

Owner / Operator Contact Address

609 E Market St Suite 114, Charlottesville, VA 22902, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hypnos Ascender Zero Knee Brace - Custom Fabricated Ascender Zero Knee Brace - Custom Fit Zeus KAFO Hercules KAFO Ascender Knee Brace Adonis Knee Brace - Custom Fabricated Adonis Knee Brace - Custom Fit Pegasus Knee Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2026-01-05
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2020-10-07

Official Correspondent

David Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Icarus Medical LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017449291. Last updated year: 2026. Please use registration number 3017449291 when referencing this establishment in official correspondence.