TRUMEDX LLC

FDA Device Registration & Listing · Shelton, CT, US · Registration 3032062344

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
3032062344
FEI Number
3032062344
Entity Name
TRUMEDX LLC
City/State/Country
Shelton, CT, US
Establishment Address
1 Parrott Dr Ste 400, Shelton, CT 06484, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
TrumedX LLC (Owner Number: 10091324)
Owner / Operator Contact Address
1 Parrott Dr, Shelton, CT 06484, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MOBIL-IZE Shoulder TruEDEMA Slinger 90 TRU-X10790 Slinger TRU-X107 TruLuminate MOBIL-IZE Cryo Hip TruMedX Wraps MOBIL-IZE KNEE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IQQ Joint, Shoulder, External Limb Component Physical Medicine Class 1 890.3420 2025-03-21
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2025-03-21
ILI Sling, Arm Physical Medicine Class 1 890.3640 2025-03-13
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2026-05-12
ITS Joint, Hip, External Brace Physical Medicine Class 1 890.3475 2025-03-21
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2026-05-29
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2026-05-29
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2026-05-29
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2025-03-21

Official Correspondent

Bill Dai

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TrumedX 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
K170216 Tactile Systems Technology, Inc. (Dba Tactile Medical) Flexitouch System 2017-05-26
K100306 Covidien KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES 2010-05-04
K242140 Jiale Health Technology Shenzhen Co., Ltd. Air Compression Leg Massager (K-705) 2025-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032062344. Last updated year: 2026. Please use registration number 3032062344 when referencing this establishment in official correspondence.
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