H200 Wireless

GUDID 00815962020290

Clinician Programmer Software

BIONESS INC.

Hand orthosis
Primary Device ID00815962020290
NIH Device Record Key0e630231-8dbb-4e6c-8611-eb054d1b3f45
Commercial Distribution StatusIn Commercial Distribution
Brand NameH200 Wireless
Version Model NumberH2W-SW01
Company DUNS182287727
Company NameBIONESS INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100815962020290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZISTIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-08

Devices Manufactured by BIONESS INC.

00815962021464 - StimRouter User Kit2022-10-25 External Electrical Field Conductor
00815962020610 - Bioness Integrated Therapy System, BITS 3.0, BITS Balance2020-08-18 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 Balance2020-08-18 BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
00815962020634 - BITS Motion Sensor2020-08-18 Bioness Integrated Therapy System Version 3.0 Motion Sensor
00815962020337 - L100 Go System2020-04-30 L100 Go System, Right
00815962020344 - L100 Go System2020-04-30 L100 Go System, Left
07290110482008 - NESS H200® Wireless Hand Rehabilitation System2019-11-08 H200 Wireless US System kit, Right Medium
07290110482015 - NESS H200® Wireless Hand Rehabilitation System2019-11-08 H200 Wireless US System kit, Left Medium

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