# K081602: Dizzyfix

- Pathway: 510(k) (Traditional)
- Applicant: Clearwater Clinical Limited
- Decided: Sep 19, 2008 after 105 days
- Product code: LXV (Apparatus, Vestibular Analysis)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K946229 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071973: Epley Omniax, Vesticon (2008). Cleared while this submission was under review Summary page 2.
- K070676: Korebalance (Kinesthetic Ability Trainer), Sportkat, LLC (2007) Summary page 2.
- K070085: Balance Rehabilitation Unit (Bru), Medicaa (Uruguay) S.A. (2007) Summary page 2.

## Indications for use
1. Patients with a diagnosis of Posterior Canal Benign Paroxysmal Positional Vertigo (BPPV) who exhibit: a. Momentary spinning dizziness, b. Which lasts seconds to minutes, c. Which is associated with position change Clinical settings 1. Physician offices 2. Hospitals 3. Long Term, Urgent and Emergent care facilities 4. Patient's homes 5. Allied Health and Complementary Health clinics and offices Target population 1. Adults (age >18) 2. For use by patients or health practitioners

Source page: https://510kreport.com/device/K081602
Methodology: https://510kreport.com/methodology