NESS H200® Wireless Hand Rehabilitation System 501-00095-01
GUDID 07290110482053
H200 Wireless US Clinician Kit Large
BIONESS INC.
Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 07290110482053 |
| NIH Device Record Key | 46f96338-de47-4574-9395-a293a6d74d15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NESS H200® Wireless Hand Rehabilitation System |
| Version Model Number | H2W-4100 |
| Catalog Number | 501-00095-01 |
| Company DUNS | 182287727 |
| Company Name | BIONESS INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il | |
| Phone | +97297907100 |
| info@bioness.co.il |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290110482053 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123636
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 | 2019-11-08 |
| Device Publish Date | 2017-02-02 |
On-Brand Devices [NESS H200® Wireless Hand Rehabilitation System]
| 07290110482084 | H200 Wireless US Clinician Upgrade Kit |
| 07290110482077 | H200 Wireless US System kit, Left Small |
| 07290110482060 | H200 Wireless US System kit, Right Small |
| 07290110482053 | H200 Wireless US Clinician Kit Large |
| 07290110482046 | H200 Wireless (US) Clinician Kit, Small / Medium |
| 07290110482039 | H200 Wireless US System Kit, Left Large |
| 07290110482022 | H200 Wireless US System Kit, Right Large |
| 07290110482015 | H200 Wireless US System kit, Left Medium |
| 07290110482008 | H200 Wireless US System kit, Right Medium |
Trademark Results [NESS H200]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NESS H200 78915006 3378669 Dead/Cancelled |
BIONESS INC. 2006-06-22 |
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