TOP SHELF MANUFACTURING, LLC

FDA Device Registration & Listing · Tracy, CA, US · Registration 3003890514

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003890514
FEI Number
3003890514
Entity Name
TOP SHELF MANUFACTURING, LLC
City/State/Country
Tracy, CA, US
Establishment Address
1851 E. PARADISE ROAD, SUITE A, Tracy, CA 95304, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
TOP SHELF MANUFACTURING, LLC (Owner Number: 9054233)
Owner / Operator Contact Address
1851 E. PARADISE RD, SUITE A, --, Tracy, CA 95304, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Toe Repair Kit Cold Gel Wrap Crutch TR CC Post-op Knee, Over The Shoulder Humeral Fracture Brace, TR CC w/Covered Hinge TeleRange Post-op Brace, TR Post-op Brace, TR Rapid Fit Post-op Brace, TR Rehab Post-op Brace, AB/EX Shoulder Strap TeleRange 2 Post-op Brace, Posterior Night Splint, ROM Universal Post-op Knee, Anchor Shoulder Brace Bader Leg Holder Compact Sleeve, Traction Sleeve, Standard Sleeve, Standard Sleeve w/Strap Lunar Walker, Lunar Air Walker, Horizon Walker, Air Horizon Walker, Air/Gel Ankle Stirrup, Air Ankle Stirrup Gauntlet Pro Cinch 2 Ankle Stabilizer, Hinged Gauntlet Pro Cinch 2 Ankle Stabilizer, Solar Air Walker Ankle Stabilizer, The Gauntlet Ankle Stabilizer, The Gauntlet Pro Ankle Stabilizer, Hinged Ankle Stabilizer Hinged Ankle Stabilizer, Hinged Gauntlet Pro, Gauntlet Pro Cinch Ankle Stabilizer, Solar Air Walker Ankle CPM Pads, SYSTEM Kit, TEAM Kit, FLEX Kit Shoulder Holder Under Brace Sleeve, Thigh Sleeve, Calf Sleeve, Elbow Sleeve, Tendonitis Strap, Knee Sleeve, Patella Stabilizer Adjustable Patella Buttress w/Contour Hinge, Adjustable Patella Buttress, Economy Hinged Knee, Sports Cover RelOAd Knee Brace, Lateral Patella Stabilizer, Tri-Panel Knee Immobilizer, Knee Immobilizer, Protex Elbow Brace Target OA Knee Brace, TeleRange Post-op Elbow, Knee Tube Hinged Knee w/Covered Hinge, Hinged Lateral Patella Stabilizer Lateral Patella Stabilizer w/Contour Hinge, Hinged Knee Plus Half Wrap, The Crusader, Knight Lite Hinged Knee Plus, Hinged Knee, Revolution Knee Brace, The Knight Brace, Protex Elbow Brace, The Knight OA Hip ROM Post-Op Brace Tracy Collar, Cervical Collar Suede Laceup Wrist Support, I-Fit Wrist Forearm Support, Univ Thumb Lacer, Thumb Lacer, Univ Gel Wrist CMC Thumb Splint, Wrist Sleeve, Univ Thumb Splint, Univ Wrist Laceup Forearm Support, Pro Wrap Wrist I-Fit Wrist Support, I-Fit Wrist Supp w/Thumb, Suede Looplock Wrist Support, Univ Laceup Wrist Support Shoulder Immobilizer Univ, High Hand Sling, Stable Sling3 ER, Open Stable Sling, Open Stable Sling SPS, Stable Sling, Stable Sling Universe, Stable Sling 2, The Remedy, The Remedy 2, Arm Sling, Arm Sling w/Padded Strap Arm Sling with Open Pocket, Arm Sling w/Padded Strap, Shoulder Immobilizer w/Web Strap, Shoulder Wrap Shoulder Immob. Sling w/Foam Strap, Shoulder Wrap Sleeve, Conformer Shoulder Immob. Arm Sling with Pad, Stable Sling Only, Stable Sling3 Only, SPD Shoulder Positioning Device, Stable Sling 3 Universe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile General, Plastic Surgery Class 1 878.3910 2017-11-28
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2019-05-31
IPR Crutch Physical Medicine Class 1 890.3150 2014-08-21
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2003-10-09
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2023-08-17
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 2020-10-27
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2002-12-10
IOD Components, Exercise Physical Medicine Class 1 890.5350 2002-12-10
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2003-07-16
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2002-12-10
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2021-05-06
ITS Joint, Hip, External Brace Physical Medicine Class 1 890.3475 2021-09-27
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2009-01-08
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2002-12-10
ILI Sling, Arm Physical Medicine Class 1 890.3640 2002-12-10

Official Correspondent

CRAIG KOLOSKE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TOP SHELF MANUFACTURING, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K812396 Northwest Surgical Concepts, Inc. ARTHRO-PREP REST 1981-11-20

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 3003890514. Last updated year: 2026. Please use registration number 3003890514 when referencing this establishment in official correspondence.
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