Bioness Integrated System (BITS) Bedside Configuration

GUDID 00810188050021

Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Display with Software

Bioness Medical, Inc.

Perceptual-coordination assistive training device
Primary Device ID00810188050021
NIH Device Record Key359b7f8a-f658-4fe7-ac11-eee1d1b1b85b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioness Integrated System (BITS) Bedside Configuration
Version Model NumberBIT-2124
Company DUNS119378513
Company NameBioness Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810188050021 [Primary]
GS100815962020122 [Previous]

FDA Product Code

IKKSystem, Isokinetic Testing And Evaluation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-28
Device Publish Date2025-07-18

Devices Manufactured by Bioness Medical, Inc.

00810188050014 - Vector Gait and Safety System2025-07-28 Vector Gait and Safety System, Elite Model
00810188050021 - Bioness Integrated System (BITS) Bedside Configuration2025-07-28Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Display with Software
00810188050021 - Bioness Integrated System (BITS) Bedside Configuration2025-07-28 Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Display with Software
00810188050045 - Bioness Integrated Therapy System, BITS 3.0, BITS Balance2025-07-28 BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
00810188050052 - L360 Thigh System2025-07-28 L360 Thigh System Kit, Right
00810188050083 - L300 Go System2025-07-28 L300 Go System, Left Lower
00810188050120 - L300 Go System2025-07-28 L300 Go System, Left Thigh Plus
00810188050175 - L100 Go System2025-07-28 L100 Go System, Left
00810188050274 - L300 Go System2025-07-28 Quick Fit Electrode, Right

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