HYPERION MEDICAL

FDA Device Registration & Listing · ADDISON, TX, US · Registration 3007674911

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
3007674911
FEI Number
3007674911
Entity Name
HYPERION MEDICAL
City/State/Country
ADDISON, TX, US
Establishment Address
15932 MIDWAY RD, ADDISON, TX 75001, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
Hyperion Medical (Owner Number: 10033629)
Owner / Operator Contact Address
15914 Midway Road, Addison, TX 75001, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

STX4 Smart-RST

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LQW Test, Temperature Discrimination Neurology Class 1 882.1200 2025-03-04
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2024-11-19

Official Correspondent

Scott Day

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hyperion Medical
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 3007674911. Last updated year: 2026. Please use registration number 3007674911 when referencing this establishment in official correspondence.
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