TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS

K071445 · Escada International, Inc. · ILY · Oct 29, 2007 · Physical Medicine

Device Facts

• Record ID: K071445
• Device Name: TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS
• Applicant: Escada International, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Oct 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TerraQuant MQ2000 v.5 with the TQ-1TENS is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated, as well as for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.

Device Story

TerraQuant MQ2000 v.5 with TQ-1TENS is a multi-modality therapeutic device combining infrared lamp technology with TENS (Transcutaneous Electrical Nerve Stimulation). Device delivers infrared light and electrical stimulation to target tissues. Used in clinical or home settings for pain management, muscle relaxation, and circulation improvement. Operated by patients or healthcare providers. Output consists of thermal energy and electrical pulses applied to the skin surface. Clinical benefit includes symptomatic pain relief and adjunctive treatment for acute/chronic pain conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Device combines infrared lamp (21 CFR 890.5500) and TENS stimulation. Class II device. Product codes: ILY (Infrared lamp), GEX, GZJ. System includes infrared emitter and electrical nerve stimulation circuitry.

Indications for Use

Indicated for patients requiring temporary relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, and local blood circulation increase; also for symptomatic relief/management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2007

Escada International, Inc. % Regulatory Insight, Inc. Mr. Kevin Walls Principal Consultant 13 Red Fox Lane Littleton, Colorado 80127

Re: K071445

Trade/Device Name: TerraQuant MQ2000 v.5 with TQ-1TENS Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY, GEX, GZJ Dated: September 27, 2007 Received: September 28, 2007

Dear Mr. Walls:

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

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Page 2 - Mr. Kevin Walls

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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance · at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

O.O.V.m
asp D.N.
10/29/21

Mark N. Melkerson Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _________________

Device Name: TerraQuant MQ2000 v.5 with the TQ-1TENS

Indications for Use: The TerraQuant MQ2000 v.5 with the TQ-1TENS is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated, as well as for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, Page 1 of 1 and Neurological Devices 510(k) Nm