Korebalance Premiere

GUDID 00858458007009

The Korebalance® is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreation centers, health and fitness clubs, universities, and professional sports teams. The Korebalance® System uses the latest in interactive technology, offering innovative high-tech balance assessment and training. Backed by over two decades of medical experience, the Korebalance® will provide you and your patients with the best possible documented neurosensory assessment and training.

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 Balance/cognitive function analysis system
Primary Device ID00858458007009
NIH Device Record Key45ff45b9-4234-4c22-8120-a11aa74d4544
Commercial Distribution Discontinuation2027-07-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameKorebalance Premiere
Version Model NumberKB01
Company DUNS048174391
Company NameDiversified Healthcare Development, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
Phone800-831-7665
Emailinfo@medicalfitsolutions.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858458007009 [Primary]

FDA Product Code

LXVApparatus, Vestibular Analysis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-08
Device Publish Date2023-07-31

Devices Manufactured by Diversified Healthcare Development, LLC

00008600088282 - Koresway2023-08-30 The FDA-listed KoreSway™ Kompact incorporates the patented Korebalance™ software suites into a compact and affordable packag
00858458007009 - Korebalance Premiere2023-08-08The Korebalance® is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreation centers, health and fitness clubs, universities, and professional sports teams. The Korebalance® System uses the latest in interactive technology, offering innovative high-tech balance assessment and training. Backed by over two decades of medical experience, the Korebalance® will provide you and your patients with the best possible documented neurosensory assessment and training.
00858458007009 - Korebalance Premiere2023-08-08 The Korebalance® is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreat
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