Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2030775

FEI Number

3000206792

Entity Name

ASPEN MEDICAL PRODUCTS, LLC

City/State/Country

IRVINE, CA, US

Establishment Address

6481 OAK CANYON, IRVINE, CA 92618, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ASPEN MEDICAL PRODUCTS, LLC (Owner Number: 9027491)

Owner / Operator Contact Address

6481 OAK CANYON, --, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VISTA COLLAR VISTA MULTIPOST THERAPY COLLAR VRTX COLLAR VRTX TX COLLAR VRTX MULTI POST COLLAR SIERRA COLLAR ASPEN COLLAR VISTA TX COLLAR ASPEN PEDIATRIC COLLAR Aspen Therapy Pack DuAlign OA Aspen OA Knee Wrap Aspen OA Knee+ CROSS-FIT MIN-KNEE Paladin XT WRAP-AROUND Comfortrac Air Walker Walker High Top Dorsal Night Splint Aero Walker Walker Low Top Traverse Air Walker Advanced QUICK LACE VerteShield Apex SUMMIT TLSO ASPEN CTO Sierra TLSO PEAK SCOLIOSIS BRACING SYSTEM CONTOUR TLSO HORIZON TLSO VISTA TLSO VISTA CTO ASPEN TLSO 457 ASPEN TLSO EVERGREEN TLSO ASPEN OTS 457 TLSO ASPEN SCOLIOSIS BRACING SYSTEM Aspen Active P-TLSO Aspen Acute TLSO Sierra Hyperextension TLSO Elite TLSO VRTX TLSO VISTA II CTLSO VRTX CTO ALIGN ORTHOSIS VRTX CTLSO FLX TLSO M2 AFO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	1996-08-16
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-01-31
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2020-07-27
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2023-03-03
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2021-11-18
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	1997-05-23
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2020-07-27

Official Correspondent

JAMES CLOAR

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ASPEN MEDICAL PRODUCTS, LLC

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

View Entity Profile →

Other Registrations for Same Entity

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3011219098	MFG AMP	Tijuana Baja California, MX
2530195	ADVANCED ORTHOPAEDICS, LLC	Bloomsburg, PA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030775. Last updated year: 2026. Please use registration number 2030775 when referencing this establishment in official correspondence.