FDA Registration
Active
🇺🇸 United States
ASPEN MEDICAL PRODUCTS, LLC
Reg #: 2030775
·
FEI: 3000206792
·
Expires 2026
Products
11
Proprietary Names
111
Establishment Types
4
Classifications
11
Registration Details
- Registration Name
- ASPEN MEDICAL PRODUCTS, LLC
- Registration Number
- 2030775
- FEI Number
- 3000206792
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6481 OAK CANYON
- City
- IRVINE
- State
- CA
- ZIP
- 92618
- Country
- US
Owner / Operator
- Firm Name
- ASPEN MEDICAL PRODUCTS, LLC
- Operator Number
- 9027491
- Address
- 6481 OAK CANYON, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- JAMES CLOAR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 1996-08-16 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2025-01-31 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2020-07-27 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2023-03-03 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2021-11-18 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 1997-05-23 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2020-07-27 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 1998-10-14 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2020-09-02 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2025-12-24 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2025-12-24 |
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
ASPEN LSO LOW PROFILE
VISTA LOWER SPINE
CONTOUR LSO
Elite
Aspen Lumbar
Horizon
Sierra
FLX
VRTX
Aspen OTS
Summit
Core
Lumbo Lite
Breathe Lite
Popple
Transformer
Silicone Elastic
Elastic Slip-On
Active Compression
Universal
OA Forte Unloader Knee Brace
Velpeau Immobilizer
Premium Wrist Brace
Air Lite
Tracer
ROM Telescoping Post Op Elbow Brace
Ankle Helper
Deluxe Shoulder Abduction System
Stabilizer
Aspen Knee Suspension Wrap
Aspen Hinged Knee
Aspen Hinged Wrist
Aspen ROM Knee
Aspen Ci Knee
Lace-Up Ankle
Carpal Tunnel Wrist Brace
Cock-up Elastic Wrist Brace
Sport Lite
Wrap-Around
Thumb Spica Wrist Brace
K.S. Lace-Up
Quick Lace
Neoprene Tennis Elbow Sleeve
Sport Knee
Gator Wrap
Premium Thumb
ROM Telescoping Post Op Knee Brace
Panther Unloader Knee Brace
Hinge ROM Elbow
Neoprene Thigh Sleeve
Min-Knee
PFS Night Splint
Cross-Fit
Visco-Gel Silicone
Air-Gel
Shoulder Pillow
Air-Lite
Premium Arm Sling
Classic Post-Op
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device