NESS H200® Wireless Hand Rehabilitation System 501-00176-01
GUDID 07290110482084
H200 Wireless US Clinician Upgrade Kit
BIONESS INC.
Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 07290110482084 |
| NIH Device Record Key | c87c2777-a2b2-45e8-ab32-66cbae4f5b38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NESS H200® Wireless Hand Rehabilitation System |
| Version Model Number | H2W-4700 |
| Catalog Number | 501-00176-01 |
| 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
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290110482084 [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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