Sport-Z

GUDID B872SPZ2000

PRIZM MEDICAL, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device IDB872SPZ2000
NIH Device Record Key543c249a-7770-4a84-833c-3e71fd50bf68
Commercial Distribution StatusIn Commercial Distribution
Brand NameSport-Z
Version Model NumberSPZ200
Company DUNS790271118
Company NamePRIZM MEDICAL, INC.
Device Count100
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB872SPZ2000 [Primary]
HIBCCD20008U4 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

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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