TANDA RESTORE, MODEL PTSCS

K090008 · Pharos Life Corporation · ILY · Oct 15, 2009 · Physical Medicine

Device Facts

• Record ID: K090008
• Device Name: TANDA RESTORE, MODEL PTSCS
• Applicant: Pharos Life Corporation
• Product Code: ILY · Physical Medicine
• Decision Date: Oct 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The Tända Restore System is an over-the-counter device intended for use whenrever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional for the purpose of providing temporary relief of minor aches and pains in muscles and joints.

Device Story

Tända Restore is a modular platform featuring an LED array head that emits infrared energy at 870 nm. Designed for over-the-counter use, the device provides topical heating to the human body. By elevating and maintaining tissue temperature, it facilitates muscle relaxation, temporary pain relief, and increased local blood circulation. Users apply the device to areas experiencing minor aches, pains, or stiffness. The device serves as a therapeutic heating tool for personal comfort or as recommended by a medical professional.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (electrical safety) and ISO 10993 (biocompatibility) was demonstrated.

Technological Characteristics

Modular platform with LED array head; infrared energy emission at 870 nm wavelength. Complies with IEC 60601-1 and ISO 10993 standards.

Indications for Use

Indicated for individuals seeking temporary relief of minor muscular pain, joint pain, and stiffness; muscle relaxation; temporary improvement in range of motion; and temporary increase in local blood circulation via topical heating.

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.

Predicate Devices

• Light Relief Pain Relief Device (K070974)
• MedX (K020017)
• Quantum WARP 10 Light Delivery System (K032229)

Submission Summary (Full Text)

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K090008

### 510(k) Summary of Safety and Effectiveness

Submitted by: Pharos Life Corporation 11-380 Jamieson Parkway Cambridge, Ontario N3C 4N4

# 1. Date Prepared:

July 16, 2009

## OCT 1 5 2009

### 2. Contact Person:

Gordon Wehner Tel: [phone] x225 Fax: [phone] Email: [e-mail]

#### 3. Device Name and Classification:

| Device | Lamp, infrared, therapeutic heating | |
|------------------------------|-------------------------------------|--|
| Regulation Description | Infrared lamp | |
| Regulation Medical Specialty | Physical Medicine | |
| Review Panel | Physical Medicine | |
| Product Code | ILY | |
| Submission Type | 510(k) | |
| Regulation Number | 890.5500 | |
| Device Class | 2 | |

#### 4. Intended Use:

The Tända Restore System is an over-the-counter device intended for use whenrever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional for the purpose of providing temporary relief of minor aches and pains in muscles and joints.

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### 5. Substantial Equivalence:

| Predicate<br>Device Name(s) | Applicant | 510(k) Number | Date of FDA<br>Clearance |
|---------------------------------------------|-------------------|---------------|--------------------------|
| Light Relief Pain<br>Relief Device | Light Relief, LLC | K070974 | May 24, 2007 |
| MedX | MedX Health Corp | K020017 | July 12, 2002 |
| Quantum WARP<br>10 Light Delivery<br>System | Quantum Devices | K032229 | Nov 3, 2003 |

### 6. Device Description

The Tanda Restore is a modular platform which supports and infrared lamp (LED Array Head) for the purposes of applying infrared heat to the human body. It consists of LED infrared lamps emitting infrared energy in the wavelength of 870 nm.

## 7. Comparison of Technological Differences

The intended use and technological characteristics of the Tanda Restore are virtually identical to the combined intended uses and technological characteristics of the listed equivalent predicate devices. Any differences between the Tanda Restore System and the equivalent devices have no significant influence on the safety or effectiveness of the Tanda Restore System.

### 8. Additional Safety Data

The Tanda Restore System has undergone certification to IEC 60601-1. In addition, testing and analysis have demonstrated compliance to ISO 10993 (biocompatibility).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three curved lines representing the wings.

Pharos Life Corporation % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313

Re: K090008

Trade/Device Name: Tända Restore™ Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: September 29, 2009 Received: September 30, 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

OCT 1 5 2009

#### Dear Mr. Job:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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#### Page 2 – Mr. Mark Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mad A. Mellem

Mark N. Melkerson Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Device Name: Tända Restore™

Indications For Use:

Tända Restore is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature. Use wherever heat application is prescribed for personal comfort and the temporary relief of minor muscular pain, joint pain and stiffness. Provides temporary relief of minor aches and pains in muscles and joints. Aids in the relaxation of muscles. Helps provide a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief. Provides a temporary increase in local blood circulation.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vaughn V. Lung FOR M.MELKERSON

(D) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090008