ERCHONIA PL2000

K012580 · Tuco Innovations, Inc. · NHN · Jan 17, 2002 · Physical Medicine

Device Facts

• Record ID: K012580
• Device Name: ERCHONIA PL2000
• Applicant: Tuco Innovations, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TUCO Erchonia PL2000 is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Device Story

The TUCO Erchonia PL2000 is a non-heating lamp device used for pain therapy. It is intended for adjunctive use in the temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin. The device is operated by healthcare professionals in a clinical setting. It functions as a therapeutic lamp; however, the provided documentation does not detail the specific input signals, internal transformation processes, or output mechanisms beyond its classification as a non-heating lamp for pain therapy.

Clinical Evidence

No clinical data provided; the document is a 510(k) clearance letter.

Technological Characteristics

Non-heating lamp; Class II; Product Code NHN; Regulation 21 CFR 890.5500.

Indications for Use

Indicated for patients experiencing minor chronic neck and shoulder pain of musculoskeletal origin requiring adjunctive pain relief.

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

JAN 1 7 2002

TUCO Innovations, Inc. C/0 Kevin Walls Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127

Re: K012580

Trade/Device Name: TUCO Erchonia PL3000 Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Non-Heating, for Adjunctive Use in Pain Therapy Regulatory Class: Class II Product Code: NHN Dated: November 7, 2001 Received: November 19, 2001

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 he 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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Page 2 - Mr. Kevin Walls

This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to organization of substantial equivalence of your device to a legally prematicated predicated on: "The Promote sification 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 and If you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CHT Part 0671 or storestions on the promotion and advertising of Compliance at [phone]. The newslance at [phone]. Also, please note the your device, produce connect and e reference to premarket notification" (21CFR Part 807.97). I guilation chittined, "Misoranang of router the Act may be obtained from the Oiner general mionnation on your respectional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

L. Mark N. Mulhern

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

TUCO Erchonia PL2000 Device Name:

Indications for Use: The TUCO Erchonia PL2000 is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number

b. Mark M. Millman

Division of General, R storative and Neurological _ rvices

510(k) Number_

X Prescription Use (Per 21 CFR 801.109)