Stim-Support Shoulder - XL

GUDID B872SSS23050

PRIZM MEDICAL, INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: B872SSS23050
• NIH Device Record Key: 731f142d-a881-4ce3-ad77-ef410b0f8424
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stim-Support Shoulder - XL
• Version Model Number: SSS 2305
• Company DUNS: 790271118
• Company Name: PRIZM MEDICAL, INC.
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B872SSS23050 [Primary]
HIBCC	C20004Y3 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944487

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-19
• Device Publish Date: 2020-05-11

Devices Manufactured by PRIZM MEDICAL, INC.

• D20007 - Micro-Z II: 2021-02-19
• B872EMG20140 - Electro-Mesh Glove: 2020-05-19
• B872EMG20150 - Electro-Mesh Glove: 2020-05-19
• B872SPZ2000 - Sport-Z: 2020-05-19
• B872SSS23050 - Stim-Support Shoulder - XL: 2020-05-19
• B872SSS23050 - Stim-Support Shoulder - XL: 2020-05-19
• B872MZM1000 - Micro-Z Mini: 2020-05-15
• B872MZS2KIT20 - Micro-Z II: 2020-05-15
• B872REVSTM20 - ReviStim: 2020-05-15