KOREBALANCE (KINESTHETIC ABILITY TRAINER)

K070676 · Sportkat, LLC · LXV · Apr 18, 2007 · EN

Device Facts

• Record ID: K070676
• Device Name: KOREBALANCE (KINESTHETIC ABILITY TRAINER)
• Applicant: Sportkat, LLC
• Product Code: LXV · EN
• Decision Date: Apr 18, 2007
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Korebalance™ device is intended for use in balance therapy, only by health care professionals with experience in balance therapy. Patient suitability must be judged by the health professional on a case by case basis.

Device Story

Korebalance Kinesthetic Ability Trainer is a computerized postural pressure platform for balance therapy. Device utilizes a balance board with bladder design technology to measure patient balance performance. Input consists of patient physical maneuvers on the platform; system captures bladder pressure measurements. Software provides a touchscreen GUI for patient interaction, displaying instructions, visual feedback, and rehabilitation games. Therapist uses the system to select preprogrammed protocols for vestibular training, orthopedic therapy, and falls prevention. Output includes quantitative performance scores and electronic patient records, allowing therapists to monitor progress over multiple sessions. Device is used in clinical settings under therapist supervision. System facilitates therapy planning and provides an engaging environment for patients to improve balance skills.

Clinical Evidence

No clinical data. Bench testing performed in accordance with design control provisions of the quality system regulation to demonstrate safety and performance equivalence to the predicate device.

Technological Characteristics

Balance board with bladder pressure sensing technology. System includes a computer with touchscreen GUI. Software provides preprogrammed static and dynamic test protocols and 3D rehabilitation games. Connectivity includes electronic patient record storage. Device is intended for professional use in clinical settings.

Indications for Use

Indicated for use in balance therapy by experienced healthcare professionals. Patient suitability determined on a case-by-case basis by the professional.

Predicate Devices

• K.A.T. 1000 (K911795)

Submission Summary (Full Text)

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K070676

Special 510k Korebalance Kinesthetic Ability Trainer SportKAT, LLC

#### 510k Summary

APR 1 8 2007

510k Owner: SPORTKAT, LLC 1497 Poinsettia Avenue, Suite 157 Vista. CA 92083 FDA Registration #: 2031091

#### Contact:

Mr. Damon Lawson Cell [phone] Phone: [phone] FAX: [phone]

Summary Date: March 6, 2007

Device Trade Name: Korebalance™ Kinesthetic Ability Trainer Common or Usual Name: Apparatus, Vestibular Analysis (Computerized Postural Pressure Platform) Classification: Unclassified Product Code: LXV

Predicate Device: This Special 510k is for changes to the previously cleared K.A.T. 1000 device (K911795)

Device Description: The updated Korebalance™ Kinesthetic Ability Trainer device has the same intended use and incorporates the same balance board (platform) and bladder design technology as the originally cleared device. The modifications are primarily software based and allow:

- 1. Creation of a patient specific electronic record of patient information via a touchscreen GUI.
- Quantitative measurement of patient balance performance while the patient 2. executes a preprogrammed set of maneuvers or protocols with the board. The GUI provides instructions and visual feedback to the patient with regard to the maneuvers to be made and the success in executing the maneuver. The patient results are scored and saved (the information is not a clinical measurement but provides a reproducible quantitative measurement that the therapist can use to plan and monitor therapy) along with the bladder pressure measurement for use by the therapist, in conjunction with the therapist's observations, to assess patient progress over the course of multiple therapy sessions. Specific protocols are provided for vestibular training, orthopedic therapy, and falls prevention. These protocols are similar to those used with the previously cleared device.

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Special 510k Korebalance Kinesthetic Ability Trainer SportKAT, LLC

- 3. Patients to play "games" displayed on the GUI that involve performing various maneuvers on the balance platform. Performance is scored. The games provide an additional means for the therapist to provide rehabilitation that is fun and challenging for patients.
Indications for Use: The Korebalance™ device is intended for use in balance therapy, only by health care professionals with experience in balance therapy. Patient suitability must be judged by the health professional on a case by case basis.

Substantial Equivalence: The modified device has the following similarities to the original previously cleared device:

- It has the same intended use .
- . It incorporates the same balance board and bladder design technology
- . The degree of difficulty is adjustable
- The device provides a quantitative measure of performance .

Modifications include the addition of a GUI, and a computer with software that allows the entry of patient specific information, the selection of static and dynamic preprogrammed tests, test selection and the measurement and the optional storage of patient performance information. The addition of modern 3-D games provides a means for patients to increase their balance board skills under the therapist's guidance in an enjoyable manner. The changes do not materially alter the intended use or fundamental technology of the device, but serve to facilitate the provision of therapy. data collection and management.

Testing: The modifications to the existing device were made in accordance with the design control provisions of the quality system regulation and applicable guidance documents to show that the modified device is as safe, as effective, and performs as well as or better than the original device .

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services-USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three abstract human figures, possibly representing people or a family. The figures are connected and appear to be reaching upwards.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 8 2007

SPORTKAT, LLC c/o Damon R. Lawson 1497 Poinsettia Avenue, Suite 157 Vista, CA 92083

Re: K070676

Trade/Device Name: Korebalance Kinesthetic Ability Trainer Regulation Name: Vestibular Analysis Apparatus Regulatory Class: Unclassified Product Code: LXV Dated: March 5, 2007 Received: March 19, 2007

Dear Mr. Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrib/industry/support/index.html.

Sincerely yours,

M.B. Egelman S. M.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510k Korebalance Kinesthetic Ability Trainer SportKAT, LLC

### Indications for Use

K070676 510(k) Number (if known):

Device Name: Korebalance™ (Kinesthetic Ability Trainer)

Indications for Use: The Korebalance™ device is intended for use in balance therapy, only by health care professionals with experience in balance therapy. Patient suitability must be judged by the health professional on a case by case basis.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801. 109). OR

Over-The-Counter

X Prescription Use _ (Per 21 CFR 801.109)

Blvision Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devis

Use

510(k) Number

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