Korebalance Premiere KB01

by Diversified Healthcare Development LLC. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00858458007009 UDI-DI	Date31 Jul 2023Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name: Korebalance Premiere
Generic Name: Balance/cognitive function analysis system
Model / Reference: KB01

Primary DI / UDI-DI: 00858458007009
FDA Product Code: LXV
GMDN Term: Balance/cognitive function analysis system

Device Class: U
GUDID distribution status: In Commercial Distribution

Other devices from Diversified Healthcare Development LLC.

Korebalance Mobile KB05B

Unclassified
Koresway KB05

Class I

Properties

Serial Number
Manufacturing Date

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No