neoGEN

GUDID 00860000214001

RESONANT SPECIFIC TECHNOLOGIES, INC.

Physical therapy transcutaneous electrical stimulation system, line-powered

• Primary Device ID: 00860000214001
• NIH Device Record Key: bb210e4c-6392-4370-bf98-c9eb19d3e70d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neoGEN
• Version Model Number: neoGEN
• Company DUNS: 109562944
• Company Name: RESONANT SPECIFIC TECHNOLOGIES, 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: false
• 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: 866-726-3927
• Email: info@rstsanexas.com
• Phone: 866-726-3927
• Email: info@rstsanexas.com
• Phone: 866-726-3927
• Email: info@rstsanexas.com
• Phone: 866-726-3927
• Email: info@rstsanexas.com
• Phone: 866-726-3927
• Email: info@rstsanexas.com
• Phone: 866-726-3927
• Email: info@rstsanexas.com
• Phone: 866-726-3927
• Email: info@rstsanexas.com
• Phone: 866-726-3927
• Email: info@rstsanexas.com
• Phone: 866-726-3927
• Email: info@rstsanexas.com
• Phone: 866-726-3927
• Email: info@rstsanexas.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000214001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022433

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: 2
• Public Version Date: 2019-05-23
• Device Publish Date: 2019-04-25

Devices Manufactured by RESONANT SPECIFIC TECHNOLOGIES, INC.

• 00860000214056 - SynRG Light Pad: 2021-09-28
• 00860000214032 - RST-SANEXAS Basic: 2021-04-26
• 00860000214049 - RST-SANEXAS PT: 2021-04-26
• 00860000214025 - SynRG Light Pad: 2019-09-24
• 00860000214001 - neoGEN: 2019-05-23
• 00860000214001 - neoGEN: 2019-05-23
• 00860000214018 - VPX Vasopulse: 2019-05-23