GV 350 KGV

GUDID 00857771003194

BIOMEDICAL LIFE SYSTEMS, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00857771003194
• NIH Device Record Key: cb1c8987-26ce-40a4-8b6b-cfc38583ddf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GV 350
• Version Model Number: GV 350
• Catalog Number: KGV
• 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: false
• Serial Number: true
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00857771003194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932916

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-23
• 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