The WS-501 Heat Lamp may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the WS-501 Heat Lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Description

The WS-501 Heat Lamp is used to provide topical heating to the body. The WS-501 Heat Lamp is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 0.5 to 13,500 microns. The emission heating plate life ranges from 5,000 to 10,000 hours of usage. 110 volt power, 20 watts with hi and low switch. Hand held model also features a table top stand. Warm up time before use is 3 to 5 min.

AI/ML Overview

This document does not contain information related to specific acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert qualifications, or adjudication methods for the WS-501 Heat Lamp.

The provided text is a 510(k) summary for the WS-501 Heat Lamp, which explicitly states:

(b)(1)(2)(3) Substantial equivalence is not based on an assessment of performance data. (Page 6c)

This indicates that the device's pre-market notification was based on demonstrating substantial equivalence to existing predicate devices (WS Portable Infrared Heat Lamp, CAI Industries, 510k # K-954577; TDP CQ-27 Heat Lamp, Lhasa Medical, Inc, 510k #: K-003538; Firard II TDP Lamp, Helio Medical Supplies, 510k #: K-960036), rather than through a study evaluating specific performance criteria against predefined acceptance thresholds. The equivalence is based on similar design, indications for use, technological characteristics (heating plate method, power, output), function, and operation.

Therefore, I cannot populate the requested tables or answer the specific questions about acceptance criteria, performance data, or study methodologies.

Summary

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KO13 i 97

AUG 2 9 2002

PAGE
1 OF 2

LHASA MEDICAL, INC.

(781) 340-1071 234 Libbey Parkway, Weymouth, MA 02189 (or fax: 781-335-6296)

September 21, 2001

Page 6a

PRE-MARKET NOTIFICATION 510(k) SUMMARY (As Required by 21 CFR 807.92)

(a)(1) Submitter:

Lhasa Medical, Inc 234 Libbey Parkway Weymouth, MA 02189 fax: 1-781-335-6296 phone: (781) 340-1071 Mrs. Kyung P. Riihimaki Contact Person: September 21, 2001 Date Summary Prepared:

(a)(2)
Name of Device:	WS-501 Heat Lamp
Common or Usual Name:	Infrared Heating Lamp
Product Code:	ILY
Classification:	Class II
510(k) Number:	K-

....... continued on next 2 pages (Page 6b and Page 6c)

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LHASA MEDICAL, INC.

234 Libbey Parkway, Weymouth, MA 02189 (or fax: 781-335-6296)

September 21, 2001

Page 6b

PRE-MARKET NOTIFICATION 510(k) SUMMARY ..... continued from previous page

(a)(3)

The WS-501 Heat Lamp is similar and/or substantially equivalent in design and performance to other brands of infrared heating lamps which have been found to be substantially equivalent through the 510(k) premarket notification process. These include the following:

· WS Portable Infrared Heat Lamp, CAI Industries, 510k # K-954577
· TDP CQ-27 Heat Lamp, Lhasa Medical, Inc, 510k #: K-003538
· Firard II TDP Lamp, Helio Medical Supplies, 510k #: K-960036

(a)(4)

Description of the WS-501 Heat Lamp.

(a)(5)

....... continued on next page (Page 6c)

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LHASA MEDICAL, INC.

234 Libbey Parkway, Weymouth, MA 02189 (781) 340-1071 fax: 781-659-9916 (or fax: 781-335-6296)

September 21, 2001

Page 6c

PRE-MARKET NOTIFICATION 510(k) SUMMARY ..... continued from previous page

(a)(6)

The WS-501 Heat Lamp meets the general specifications, criteria, and effectiveness for heat lamps. The WS-501 Heat Lamp also has the same technological characteristics as the predicate devices identified in paragraph (a)(3). The WS-501 is similar in appearance, function, and operation; and uses the same heating plate method and design and same method of power and output as these predicate devices.

(b)(1)(2)(3)

Substantial equivalence is not based on an assessment of performance data.

(c)

This Pre-Market Notification 510(k) Summary includes these 3 pages (Pages 6a, 6b, and 6c) in total.

Kyung P. Bichimaki

Mrs. Kyung P. Riihimaki, President

September 21, 2001

Date

Premarket Notification (510(k) Number): K-

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three parallel lines forming the shape of a person's head and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2002

Kyung P. Riihimaki, President Lhasa Medical, Inc. 234 Libbey Parkway Weymouth, Massachusetts 01289

Re: K013197

Trade/Device Name: WS-501 Heat Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Infrared -Regulatory Class: II Product Code: ILY Dated: May 31, 2002 Received: June 3, 2002

Dear Mrs. Riihimaki:

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. Iisting 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 reguirements 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. This

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Page 2 - Mrs. Kyung P. Riihimaki

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark McMikenna

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): K-

Device Name:

WS-501 Heat Lamp

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluations (ODE)

Mark n Melleer
Division Sign Off

neral, Restorative d Neurological Devices

510(k) Number K013197

Prescription Use _ (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
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.(b)
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.