APOLLO IR HEAT LAMP SYSTEM

K060134 · Apollo Physical Therapy Products International · ILY · Mar 21, 2006 · Physical Medicine

Device Facts

• Record ID: K060134
• Device Name: APOLLO IR HEAT LAMP SYSTEM
• Applicant: Apollo Physical Therapy Products International
• Product Code: ILY · Physical Medicine
• Decision Date: Mar 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The APOLLO IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Device Story

APOLLO IR Heat Lamp System is a non-invasive, hand-held therapeutic device providing continuous heat therapy. System consists of a control unit housing electronics and a handheld treatment probe. Device emits infrared energy to elevate tissue temperature. Used in clinical settings to provide topical heating for pain relief, muscle relaxation, and increased local blood circulation. Healthcare providers operate the device to deliver targeted thermal therapy. Output is thermal energy; clinical benefit is temporary relief of minor musculoskeletal pain and stiffness.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of functional performance and electrical safety testing in accordance with applicable standards for infrared lamp medical devices.

Technological Characteristics

Hand-held infrared lamp system. Utilizes infrared and visible laser diodes for energy emission. Comprised of a control unit and handheld treatment probe. Operates as a continuous heat therapy device. Complies with therapeutic heat performance specifications.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, or muscle spasm, and for temporary increase in local blood circulation or muscle relaxation.

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

• Meditech International Inc BioFlex Professional Therapy System (K023621)
• Thor International, Ltd. DDII Laser System (K033923)
• Dynatronics Solaris D890 Therapy Probe (K040729)
• Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179)
• American Spine Center, LTD. Clini-Lase Systems (K052647)
• Spectrum Laser & Technologies, Inc. Neurolase Series (K032787)

Submission Summary (Full Text)

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MAR 2 ] 2006

510k Notification APOLLO IR Heat Lamp System January 10, 2006

# APPENDIX B

K060134

# 510(k) PREMARKET NOTIFICATION SUMMARY

(per 21 CFR 807.92)

## APOLLO IR Heat Lamp System

### I. Applicant:

Apollo Physical Therapy Products International 818 North Idaho St. San Mateo, CA 94401

January 10, 2006 Date Prepared:

### II. Device Name

Proprietary Name: APOLLO IR Heat Lamp System Common / Usual Name: Infrared Lamp Infrared Lamp (21 CFR 890.5500) Classification Name: Product Code: ILY

### Intended Use of the Device III.

The APOLLO IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

### IV. Predicate Devices

Predicate devices to the APOLLO IR Heat Lamp System include, but not limited to, the Meditech International Inc BioFlex Professional Therapy System (K023621), Thor International, Ltd. DDII Laser System (K033923), the Dynatronics Solaris D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), American Spine Center, LTD. Clini-Lase Systems (K052647) and the Spectrum Laser & Technologies, Inc. Neurolase Series (K032787). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification process.

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### V. Description of the Device

The APOLLO IR Heat Lamp System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy.

## Summary of the technical characteristics of the APOLLO IR Heat Lamp VI. System to the referenced predicate devices

The APOLLO IR Heat Lamp System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.

### VII. Testing

Testing of the APOLLO IR Heat Lamp System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device.

## VIII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the APOLLO IR Heat Lamp System has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2006

Apollo Physical Therapy Products International c/o Texas Applied Biomedical Services Ms. M. Joyce Heinrich 12101-A Cullen Boulevard Houston, Texas 77047-2951

Re: K060134

Trade/Device Name: Apollo IR Heat Lamp System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: January 10, 2006 Received: January 24, 2006

Dear Ms. Heinrich:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared. 310(x) pe device is substantially equivalent (for the indications ferenced above and nave acterimes ally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars and date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Ac. (71ct) that do nov requesable to the general controls provisions of the Act. The Y ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (500 a0010) ins. Existing major regulations affecting your device can Inay be subject to subli additional comise of the 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Tease of advised that i Dris issualite over device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must of any I cucral statutes and regulations, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 007); adoning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. M. Joyce Heinrich

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wif anon you to ogen tinding of substantial equivalence of your device to a legally premaince nonification "Thesults 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 ir you desire specific as not any and [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 other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

.mll

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

Enclosure

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510k Notification APOLLO IR Heat Lamp System January 10, 2006

## APPENDIX A

# STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): Pending

Device Name:

## APOLLO IR Heat Lamp System

## Indications for Use:

The APOLLO IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Prescription Use: X (Part 21 CFR 801 Subpart D)

.

AND/OR

Over the Counter Use: _ (21 CFR 807 Subpart C)

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

> Office of Device Evaluation (ODpE) Concurrence of C

> > (Division Sign Off Division of General, Restorative. and Neurological Devices

510(k) Number_K060(34