Koresway

GUDID 00008600088282

The FDA-listed KoreSway™ Kompact incorporates the patented Korebalance™ software suites into a compact and affordable package. Utilizing proven force transducers and rapid sampling rates, the KoreSway™ captures the minute patient center of gravity movements. Includes a portable safety rail system with integrated wheels that fits through standard-size doorways.

Diversified Healthcare Development, LLC

Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system Balance/cognitive function analysis system
Primary Device ID00008600088282
NIH Device Record Keyc9f63b03-46fb-4ce6-ba95-bea0bfdd249f
Commercial Distribution Discontinuation2028-08-22
Commercial Distribution StatusIn Commercial Distribution
Brand NameKoresway
Version Model NumberKB05
Company DUNS048174391
Company NameDiversified Healthcare Development, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com
Phone800-831-7665
Emailinfo@medicalfitsolutions.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100008600088282 [Primary]

FDA Product Code

KHXPlatform, Force-Measuring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-30
Device Publish Date2023-08-22

Devices Manufactured by Diversified Healthcare Development, LLC

00008600088282 - Koresway2023-08-30The FDA-listed KoreSway™ Kompact incorporates the patented Korebalance™ software suites into a compact and affordable package. Utilizing proven force transducers and rapid sampling rates, the KoreSway™ captures the minute patient center of gravity movements. Includes a portable safety rail system with integrated wheels that fits through standard-size doorways.
00008600088282 - Koresway2023-08-30 The FDA-listed KoreSway™ Kompact incorporates the patented Korebalance™ software suites into a compact and affordable packag
00858458007009 - Korebalance Premiere2023-08-08 The Korebalance® is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreat
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.