StimRouter Electrode Set

GUDID 00815962020047

Electrode Set

BIONESS INC.

Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable

• Primary Device ID: 00815962020047
• NIH Device Record Key: 0a87ff9f-db12-40ba-b4c2-46d4f0e4cd7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StimRouter Electrode Set
• Version Model Number: ST2-7000
• Company DUNS: 182287727
• Company Name: BIONESS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815962020047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142432

FDA Product Code

• GZF: STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-11
• Device Publish Date: 2016-12-19

Devices Manufactured by BIONESS INC.

• 00815962021464 - StimRouter User Kit: 2022-10-25 External Electrical Field Conductor
• 00815962020610 - Bioness Integrated Therapy System, BITS 3.0, BITS Balance: 2020-08-18 Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory
• 00815962020627 - Bioness Integrated Therapy System, BITS 3.0, BITS Balance: 2020-08-18 BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
• 00815962020634 - BITS Motion Sensor: 2020-08-18 Bioness Integrated Therapy System Version 3.0 Motion Sensor
• 00815962020337 - L100 Go System: 2020-04-30 L100 Go System, Right
• 00815962020344 - L100 Go System: 2020-04-30 L100 Go System, Left
• 07290110482008 - NESS H200® Wireless Hand Rehabilitation System: 2019-11-08 H200 Wireless US System kit, Right Medium
• 07290110482015 - NESS H200® Wireless Hand Rehabilitation System: 2019-11-08 H200 Wireless US System kit, Left Medium