Micro-Z Mini

GUDID B872MZM1000

PRIZM MEDICAL, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device IDB872MZM1000
NIH Device Record Key07e088cd-b803-48e2-a61d-636bcbc6f5df
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicro-Z Mini
Version Model NumberMZM100
Company DUNS790271118
Company NamePRIZM MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB872MZM1000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-15
Device Publish Date2020-05-07

Devices Manufactured by PRIZM MEDICAL, INC.

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B872SSKNEE0 - Stim-Support Knee Brace2024-06-17 Stim-Support Knee Brace Kit
B872SSNECK0 - Stim-Support Neck Brace2024-06-17 Stim-Support Neck Brace Kit
B872SSSHLD0 - Stim-Support Shoulder Brace2024-06-17 Stim-Support Shoulder Brace Kit
B872EMG20130 - Electro-Mesh Glove2024-06-14 Electro-Mesh Glove - Medium
B872EMSP240 - Electro-Mesh Panel2024-06-14 Electro-Mesh Panel 1.5x4
B872EMSP440 - Electro-Mesh Panel2024-06-14 Electro-Mesh Panel 4x4

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