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Regulatory Documents

United States Food and Drug Administration (FDA)

Owner/Operator Number: 9010766
510(k) Number: K942651
Medical Device Listing: B200271
Product Nomenclature: Device, Anti-Stammering
Product Code: KTH
Classification Number: 77KTH
Class: I
Regulation Number: 874.5840
Issued: October 19, 1995
Purpose: The FDA examined Casa Futura Technologies devices and found them to be safe and effective for the treatment of stuttering. For a list of all FDA-registered electronic anti-stuttering devices go to the Search 510(k) Database webpage and type "KTH" into the "Product Code" field.

CE Marking

Casa Futura Technologies devices have been declared to conform to Directive 93/42/EEC on Medical Devices, Annex VII. Tests performed by ESZ Elektronik-Service GmbH (Max-Planck-Strasse 16, D-82223 Eichenau), report 011005 (2005 March 11) found the devices in compliance with DIN-EN 61000-4-2, and in compliance with DIN-EN 55011, Class B Low Voltage Group 1.
Purpose: CE Marking approves medical devices for sale in the European Union.

Health Canada

Medical Device Establishment License Number: 1681
Issued: October 15, 2003
Purpose: Approval to manufacture Class I medical devices and sell to Canadians.

United States Federal Communications Commission (FCC)

Part 68 Equipment Registration
Registration Number: 50UUSA-23453-KX-N
File Number: 555-CX-96
Issued: January 29, 1996
Purpose: Approval to connect to telephone equipment in the United States.

Industry Canada

Certification Number: 2538 7181 A
Issued: February 2, 1996
Purpose: Approval to connect to telephone equipment in Canada.

Underwriters Laboratories

Standard: UL 1459
File Number: E173538
Issued: May 30, 1997
Purpose: Desktop Fluency System is safe when connected to AC power and telephone lines. The device can handle over 2000 volts from the telephone line (simulating a lightning strike) without shock to the user or damage to the device. Maximum volume cannot cause hearing damage.

United States Department of Commerce, Patent and Trademark Office

Patents:

1. Patent Number 5,794,203; August 11, 1998. Detection of stuttering characteristics linked to controller switching on fluency-enhancing altered auditory feedback; anti-stuttering telephones.
2. Patent Number 5,765,134; June 9, 1998. Electronic altering of user's mood via altered auditory feedback; use of this device for public speaking and on telephone calls.
3. Patent Number 6,231,500: May 15, 2001. Biofeedback system that detects stuttering characteristics via frequencies in user's voice.

Medicaid

Colorado Medicaid provider number: 08003485
New Jersey Medicaid provider number: 730 7004

Veteran's Administration

The VA does not have vender account numbers.

Codes

The CPT/HCPCS procedure code for electronic anti-stuttering devices is E1399-NU. The diagnosis code for stuttering is 307.0.

Universal Standard Product & Services Classification: 42.21.12.00
Communication aids for the physically challenged

Incorporation

CASA FUTURA TECHNOLOGIES, LLC is a Limited Liability Corporation in Good Standing in the State of Colorado, document number 20041107839, incorporated March 22, 2004.

Export Codes

One signed invoice and two copies. U.S. Shipper's Export Declaration (SED) not needed for commodities under $2500.
NAFTA Certificate of Origin not required but may reduce tariffs.
HS Tariff Classification (and Schedule B number): 9018906000, Electro-medical instruments and appliances, and parts and accessories thereof.
Preference criteria: A
Net Cost Code: No
Domestic/Foreign/Foreign Military Sales: Domestic
In Bond Code: 70
Point of Origin: CO
Parties to Transaction: Non-related
Routed Export Transaction: No
Reason for Export: Sale
License Exception Code: NLR
Terms of Sale: CIF
SIC Code: 3845 Electromedical and Electrotherapeutic Apparatus
FEIN: 20-1567801