NESS H200® Wireless Hand Rehabilitation System 501-00038-01

GUDID 07290110482015

H200 Wireless US System kit, Left Medium

BIONESS INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID07290110482015
NIH Device Record Keya2205599-393e-4bdf-a2f1-88d04cbafe7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNESS H200® Wireless Hand Rehabilitation System
Version Model NumberH2W-5200
Catalog Number501-00038-01
Company DUNS182287727
Company NameBIONESS INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110482015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, muscle, powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2017-02-02

On-Brand Devices [NESS H200® Wireless Hand Rehabilitation System]

07290110482084H200 Wireless US Clinician Upgrade Kit
07290110482077H200 Wireless US System kit, Left Small
07290110482060H200 Wireless US System kit, Right Small
07290110482053H200 Wireless US Clinician Kit Large
07290110482046H200 Wireless (US) Clinician Kit, Small / Medium
07290110482039H200 Wireless US System Kit, Left Large
07290110482022H200 Wireless US System Kit, Right Large
07290110482015H200 Wireless US System kit, Left Medium
07290110482008H200 Wireless US System kit, Right Medium

Trademark Results [NESS H200]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NESS H200
NESS H200
78915006 3378669 Dead/Cancelled
BIONESS INC.
2006-06-22

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