BITS Motion Sensor

GUDID 00815962020634

Bioness Integrated Therapy System Version 3.0 Motion Sensor

BIONESS INC.

Perceptual-coordination assistive training device
Primary Device ID00815962020634
NIH Device Record Key21f14c18-be1e-4ad2-a53c-a5dfb0f9c180
Commercial Distribution StatusIn Commercial Distribution
Brand NameBITS Motion Sensor
Version Model NumberBITS-3355
Company DUNS182287727
Company NameBIONESS INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100815962020634 [Primary]

FDA Product Code

ISDExerciser, measuring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-18
Device Publish Date2020-08-10

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 Sensor2020-08-18Bioness Integrated Therapy System Version 3.0 Motion Sensor
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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