| Primary Device ID | 00815962020290 |
| NIH Device Record Key | 0e630231-8dbb-4e6c-8611-eb054d1b3f45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | H200 Wireless |
| Version Model Number | H2W-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 |
| 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 | |
| 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 |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815962020290 [Primary] |
| GZI | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-02-08 |
| 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 |