Stim-Support Shoulder Brace

GUDID B872SSSHLD0

Stim-Support Shoulder Brace Kit

PRIZM MEDICAL, INC.

Transcutaneous electrical stimulation electrode, single-use
Primary Device IDB872SSSHLD0
NIH Device Record Keyd93b81a4-0777-4c21-8200-9349311614c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameStim-Support Shoulder Brace
Version Model NumberSSSHLD
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 Numberfalse
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
HIBCCB872SSSHLD0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-17
Device Publish Date2024-06-07

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 Brace2024-06-17Stim-Support Shoulder 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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