Intelligent Textile Stim-Support Back Wrap

GUDID B872ITBK440

Intelligent Textile Stim-Support Back Wrap Kit

PRIZM MEDICAL, INC.

Transcutaneous electrical stimulation electrode, single-use
Primary Device IDB872ITBK440
NIH Device Record Keyb166ec8a-6809-4b39-aa11-2b19500a7803
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntelligent Textile Stim-Support Back Wrap
Version Model NumberITBK44
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
HIBCCB872ITBK440 [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.

B872ITBK440 - Intelligent Textile Stim-Support Back Wrap2024-06-17Intelligent Textile Stim-Support Back Wrap Kit
B872ITBK440 - Intelligent Textile Stim-Support Back Wrap2024-06-17 Intelligent Textile Stim-Support Back Wrap Kit
B872SSELBW0 - Stim-Support Elbow Brace2024-06-17 Stim-Support Elbow Brace Kit
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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