PRIZM MEDICAL, INC.

FDA Device Registration & Listing · Buford, GA, US · Registration 1055808

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
1055808
FEI Number
1000110974
Entity Name
PRIZM MEDICAL, INC.
City/State/Country
Buford, GA, US
Establishment Address
5153 Belle Wood Ct Ste E, Buford, GA 30518, US
Establishment Type(s)
Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
PRIZM MEDICAL, INC. (Owner Number: 9005746)
Owner / Operator Contact Address
5153 Belle Wood Ct Ste E, Buford, GA 30518, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K951727
PMA Number
N/A

All Registered Proprietary Names

THERA-CREAM ELECTRO-MESH: GLOVE, SOCK, SLEEVE, WRAP & PANELS SILVER-THERA: GLOVE, SOCK, STOCKING & KNEE E-GLOVE, E-STOCKING, E-SLEEVE, E-SOCK Micro-Z Mini Micro-Z II MICRO-Z STIMULATION SYSTEM Thermo-Trace Infrared Thermometer Model #15053 Model #15045 MICRO-Z STIMULATION SYSTEM Micro-Z II Micro-Z Mini SaeboStim Micro

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GYB Media, Electroconductive Neurology Class 2 882.1275 2006-01-12
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2006-01-12
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2006-01-12
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2006-01-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-06-10
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2006-01-12

Official Correspondent

Jim Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRIZM MEDICAL, INC.
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
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1055808. Last updated year: 2026. Please use registration number 1055808 when referencing this establishment in official correspondence.
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