PRIZM MEDICAL, INC.

Reg #: 1055808 · FEI: 1000110974 · Expires 2026

View on FDA

Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: PRIZM MEDICAL, INC.
Registration Number: 1055808
FEI Number: 1000110974
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 5153 Belle Wood Ct Ste E
City: Buford
State: GA
ZIP: 30518
Country: US

Regulatory Submissions

510(k) Number: K032239

Owner / Operator

Firm Name: PRIZM MEDICAL, INC.
Operator Number: 9005746
Address: 5153 Belle Wood Ct Ste E
City: Buford
State: GA
Postal Code: 30518
Country: US
Correspondent: Jim Johnson

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Media, Electroconductive	GYB	Class 2	Neurology	No	2006-01-12
Electrode, Cutaneous	GXY	Class 2	Neurology	No	2006-01-12
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	Class 2	Neurology	No	2006-01-12
Stimulator, Muscle, Powered	IPF	Class 2	Physical Medicine	No	2006-01-12
Continuous Measurement Thermometer	FLL	Class 2	General Hospital	No	2008-06-10
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	Class 2	Neurology	No	2014-12-30

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 SaeboStim Micro E-GLOVE, E-SOCK, E-STOCKING, E-SLEEVE Sport-Z SPORT-Z

Establishment Types

Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer)