full back conductive garment vest- med. KV1003823

GUDID 00857771003521

with (8) 2x3 eletrodes

BIOMEDICAL LIFE SYSTEMS, INC.

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

• Primary Device ID: 00857771003521
• NIH Device Record Key: b93d69d6-9fa4-44d8-b457-b06ae884ff6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: full back conductive garment vest- med.
• Version Model Number: KV1003823
• Catalog Number: KV1003823
• Company DUNS: 116956807
• Company Name: BIOMEDICAL LIFE SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com

Device Dimensions

• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch
• Height: 1 Inch
• Width: 12 Inch
• Length: 12 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857771003521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053214

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-28
• Device Publish Date: 2016-09-23

Devices Manufactured by BIOMEDICAL LIFE SYSTEMS, INC.

• 00857771003354 - BioKnit Conductive Shoulder Support Garment - Kit: 2022-08-03 Conductive Shoulder Garment with 4- 2x3 Electrodes
• 00857771003385 - BioKnit Back Brace 7" Conductive Garment - Kit: 2022-08-03 Back Brace 7" Conductive Garment with 4- 2x3 Electrodes
• 00857771003347 - BioKnit conductive sock - universal fit: 2021-05-13 BioKnit conductive sock - universal fit
• 00857771003330 - BioStim M7 (low voltage): 2020-10-02 BioStim M7 - 2 batt. low voltage
• 00850706007298 - BioKnit Conductive KNEE: 2020-04-09 universal size sleeve
• 00850706007236 - Bio Knit Conductive cuff: 2020-04-01 garment cuff
• 00850706007014 - Conductive garment electrode glove med.: 2020-04-01
• 00850706007021 - Conductive garment electrode glove lg.: 2020-04-01