StimRouter
GUDID 00815962020306
Clinician Programmer Software
BIONESS INC.
Transcutaneous electrical stimulation probe Transcutaneous electrical stimulation probe Transcutaneous electrical stimulation probe Transcutaneous electrical stimulation probe Transcutaneous electrical stimulation probe Transcutaneous electrical stimulation probe Transcutaneous electrical stimulation probe Transcutaneous electrical stimulation probe Transcutaneous electrical stimulation probe Transcutaneous electrical stimulation probe Transcutaneous electrical stimulation probe Transcutaneous electrical stimulation probe| Primary Device ID | 00815962020306 |
| NIH Device Record Key | d3ec6f75-51b7-4a78-a4be-85dc8164654a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StimRouter |
| Version Model Number | ST2-SW01 |
| Company DUNS | 182287727 |
| Company Name | BIONESS INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 |
| info@bioness.com | |
| Phone | +1(800)211-9136 |
| info@bioness.com | |
| Phone | +1(800)211-9136 |
| info@bioness.com | |
| Phone | +1(800)211-9136 |
| info@bioness.com | |
| Phone | +1(800)211-9136 |
| info@bioness.com | |
| Phone | +1(800)211-9136 |
| info@bioness.com | |
| Phone | +1(800)211-9136 |
| info@bioness.com | |
| Phone | +1(800)211-9136 |
| info@bioness.com | |
| Phone | +1(800)211-9136 |
| info@bioness.com | |
| Phone | +1(800)211-9136 |
| info@bioness.com | |
| Phone | +1(800)211-9136 |
| info@bioness.com | |
| Phone | +1(800)211-9136 |
| info@bioness.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815962020306 [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 | 2018-07-06 |
| Device Publish Date | 2018-02-08 |
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 |
Trademark Results [StimRouter]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STIMROUTER 77613107 4261635 Live/Registered |
Bioness Inc. 2008-11-12 |
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