FDA.reportPublic FDA data

Bioness Integrated System (BITS) Bedside Configuration

Primary DI
00815962020122
Brand
Bioness Integrated System (BITS) Bedside Configuration
Company
BIONESS INC.
Model
BIT-2124
Device description
"Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24"" Display with Software"
Published
2017-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKKSYSTEM, ISOKINETIC TESTING AND EVALUATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815962020122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815962020122008159620201228159620201220815962020122

GMDN Terms#

Term, Definition table
TermDefinition
Perceptual-coordination assistive training deviceA device designed to help train a person with a disability to improve their ability to correctly process and coordinate external stimuli, especially those relating to concepts of space and time, spatial concepts, and eye-hand coordination.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)211-9136info@bioness.com

Regulatory Flags#

DUNS number
182287727
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815962021464StimRouter User KitST2-50502022-10-17
00815962020528H200 Wireless SystemH2W-53002019-08-08
00815962020535H200 Wireless SystemH2W-52002019-08-08
00815962020542H200 Wireless SystemH2W-55002019-08-08
00815962020559H200 Wireless SystemH2W-54002019-08-08
00815962020566H200 Wireless SystemH2W-40002019-08-08
00815962020573H200 Wireless SystemH2W-41002019-08-08
00815962020580H200 Wireless SystemH2W-51002019-08-08
00815962020597H200 Wireless SystemH2W-50002019-08-08
00815962020603H200 Wireless SystemH2W-47002019-08-08
07290110482008NESS H200® Wireless Hand Rehabilitation SystemH2W-5300501-00037-012017-02-02
07290110482015NESS H200® Wireless Hand Rehabilitation SystemH2W-5200501-00038-012017-02-02
07290110482022NESS H200® Wireless Hand Rehabilitation SystemH2W-5500501-00041-012017-02-02
07290110482039NESS H200® Wireless Hand Rehabilitation SystemH2W-5400501-00042-012017-02-02
07290110482046NESS H200® Wireless Hand Rehabilitation SystemH2W-4000501-00094-012017-02-02
07290110482053NESS H200® Wireless Hand Rehabilitation SystemH2W-4100501-00095-012017-02-02
07290110482060NESS H200® Wireless Hand Rehabilitation SystemH2W-5100501-00120-012017-02-02
07290110482077NESS H200® Wireless Hand Rehabilitation SystemH2W-5000501-00121-012017-02-02
07290110482084NESS H200® Wireless Hand Rehabilitation SystemH2W-4700501-00176-012017-02-02
00815962020290H200 WirelessH2W-SW012018-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975343590010Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590027Lower Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590034Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590041Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590058Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590065Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590072Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590089Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590133Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590140Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590157Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590171Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590188Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590195Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590201Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590218Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590225Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590256Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590287Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590300Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
04041925006339PHS - XSmedica - Medizintechnik GmbHIKK2026-05-13
04041925006346PHS - Smedica - Medizintechnik GmbHIKK2026-05-13
04041925006353PHS - Mmedica - Medizintechnik GmbHIKK2026-05-13
04041925006360PHS - Lmedica - Medizintechnik GmbHIKK2026-05-13
04041925006377PHS - XLmedica - Medizintechnik GmbHIKK2026-05-13
B108660POMUS00R-GAITBTL INDUSTRIES LIMITEDIKK2026-03-19
09120077180250LEXOtyromotion GmbHIKK2026-03-12
06979351820015Upper Limb Rehabilitation Training SystemShanghai ZDROID Medical Technology Co.,Ltd.IKK2025-12-23
05061081950009LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03
05061081950184LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03