XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A

K043558 · Chongqing Xinfeng Medical Instruments Co., Ltd. · ILY · Jun 6, 2005 · Physical Medicine

Device Facts

• Record ID: K043558
• Device Name: XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A
• Applicant: Chongqing Xinfeng Medical Instruments Co., Ltd.
• Product Code: ILY · Physical Medicine
• Decision Date: Jun 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Xinfeng Heating lamp, including CQ-27, CQ-36 and CQ-55A, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Story

Xinfeng Heating Lamp (models CQ-27, CQ-36, CQ-55A) provides topical infrared heat therapy. Device consists of heating head, swing arm, control box, and pedestal. Operates by emitting infrared spectrum (5-25 microns for CQ-27/36/CQ-55A State I; 2-50 microns for CQ-55A State II) to heat tissue. User positions lamp head 8-12 inches from treatment area; timer controls duration up to 95 minutes. Intended for clinical or home use to relieve minor musculoskeletal pain and stiffness. Healthcare provider or patient monitors treatment distance to maintain skin temperature between 40-45°C (CQ-55A State II requires minimum 10-inch distance). Benefits include temporary pain relief and increased local circulation.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technical specifications, materials, and intended use. Safety testing performed according to IEC 60601-1.

Technological Characteristics

Infrared lamp; 110V power; 50/60 Hz; power ≤280W. Components: heating head, swing arm, control box, pedestal. Emission spectrum: 5-25 microns (standard) or 2-50 microns (CQ-55A State II). Timer: up to 95 minutes. Safety: 2 fuses, 5 casters. Tested to IEC 60601-1. Heating plate replacement required after 1,000 hours.

Indications for Use

Indicated for patients requiring topical heating to elevate tissue temperature, increase local blood circulation, and temporarily relieve minor muscle/joint pain, stiffness, muscle spasms, minor sprains, strains, and minor muscular back 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.

Predicate Devices

• TDP CQ-27 Heat Lamp (K003538)

Submission Summary (Full Text)

{0}------------------------------------------------

Additional Information for Xinfeng Heating Lamp

# 510 (k) Premarket Notification Summary

## Submitter

George Su Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, CA 90067 USA

Tel: [phone] Fax: [phone] Email: [e-mail]

### Manufacturer:

Chongqing Xinfeng Medical Instrument Co., Ltd. 12 Da Xi Gou Street 14-6 Hua Xin Tower Chongqing 400013 People's Republic of China

Tel: [phone] Fax: [phone] E-mail: wfs(@xf-tdp.com.cn

# Sponsor of the 510(k) Submission:

Chongqing Xinfeng Medical Instrument Co., Ltd. 12 Da Xi Gou Street 14-6 Hua Xin Tower Chongqing 400013 People's Republic of China

Tel: [phone] Fax: [phone] E-mail: [e-mail]

## Device Name:

Proprietary Name: Xinfeng Lamp Common/Usual Name: Infrared Lamp Device Name: Infrared Lamp Product Code: ILY Classification: Class II

# Predicate Device:

TDP CQ-27 Heat Lamp Establishment: LHASA Medical Inc.

{1}------------------------------------------------

Additional Information for Xinfeng Heating Lamp

Regulation Number: 890.5500 Product Code: ILY 510(k) Number: K003538 Registration Number: 1222811 Owner/Operator Number: 9003816

# Description of the Xinfeng Heating Lamps:

Xinfeng Heating Lamp, including 3 different models CQ-27, CQ-36 and CQ-55A, consists of heating head, swing arm, control box and pedestal with extension. It is used to provide topical heating to the body and is specially engineered using a plate. Model CQ-27 and CQ-36 have only one operating mode, while model CQ-55A has two operating modes. Emission spectrum ranges from 5 to 25 microns for models CQ-27, CQ-36 and state I of CQ-55A. Model CQ-55A also includes an additional operating state (State II) having an emission range of 2 to 50 microns. The emission heating plate shall be replaced after 1,000 hours of usage.

#### Indications for use

Xinfeng Heating Lamp, including 3 different models CQ-27, CQ-36 and CQ-55A, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain.

# Substantial Equivalence Information

Xinfeng CQ-27, CQ-36 and CQ-55A Heating Lamps are generally equivalent to CQ-27 Heat Lamp (K003538) manufactured by Lhasa Medical, Inc. on label and labeling, materials used, specifications and intended use. All the technical data are tested according to GB 9706.1-1995 which is identical to IEC 60601-1

The equivalence information is focused on intended use, materials and specifications. The Xinfeng Heating lamps use 110V voltage, 5 casters and 2 fuses. The use age is 1000 hours and the skin temperature is at 40~45°C in a treatment distance from heating unit to treatment surface 8" to12" for models CQ-27, CQ-36 and state I of CQ-55A, but for state II operating mode of CQ-55A it is 10" to12".

{2}------------------------------------------------

Additional Information for Xinfeng Heating Lamp

Table 1.

Predicate device: TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc.

The new device: Xinfeng Heating Lamp CQ-27

| Item | The predicate device | The new device | | |
|--------------------------|------------------------------------------------------------------|------------------------------------------------------------------|-------------|------------|
| Components | heating head, swing arm, control box and pedestal with extension | heating head, swing arm, control box and pedestal with extension | | |
| Power Frequency | 50/60 Hz | 50/60 Hz | | |
| Power | $\leq 250 W$ | $\leq 250 W$ | | |
| Spectrum Ranges | 2 to 50 microns | 5 to 25 microns | | |
| Warming Up Time | 15 minutes | 15 minutes | | |
| Total Working<br>Hours | 1,200 to 1500 hours | 1,000 hours | | |
| Operating Timer | Up to 60 minutes | Up to 60 minutes | | |
| Number of Fuse | 2 | 2 | | |
| Inner Cover<br>Diameter | 12 cm | 12 cm | | |
| Number of Casters | 4 | 5 | | |
| Skin Temperature<br>(°C) | The distance from the lamp head and the result | | | |
| | 8"<br>45°C | 10"<br>43°C | 12"<br>41°C | 8"<br>45°C |

Table 2.

Predicate device: TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc. The new device: Xinfeng Heating Lamp CQ-36

| Item | The predicate device | The new device | |
|-----------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------|
| Components | heating head<br>swing arm<br>standard control box<br>pedestal with extension | heating head<br>swing arm<br>control box with digital display<br>pedestal with extension | |
| Power Frequency | 50/60 Hz | 50/60 Hz | |
| Power | $\leq 250 W$ | $\leq 250 W$ | |
| Spectrum Ranges | 2 to 50 microns | 5 to 25 microns | |
| Warming Up Time | 15 minutes | 15 minutes | |
| Total Working Hours | 1,200 to 1500 hours | 1,000 hours | |
| Operating Timer | Up to 60 minutes | Up to 95 minutes | |
| Number of Fuse | 2 | 2 | |
| Inner Cover Diameter | 12 cm | 16.6 cm | |
| Number of Casters | 4 | 5 | |
| Skin Temperature (°C) | The distance from the lamp head and the result | | |
| | 8" | 10" | 12" |
| | 45°C | 43°C | 41°C |
| | 8" | 10" | 12" |
| | 44°C | 42°C | 40°C |

{3}------------------------------------------------

4/4

Additional Information for Xinfeng Heating Lamp

Table 3.

Predicate device: TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc. The new device: Xinfeng Heating Lamp CQ-55A

| Item | The predicate device | The new device |
|---------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Components | heating head with one heating unit<br>swing arm<br>standard control box<br>pedestal with extension | heating head with three heating unit<br>swing arm<br>control box with digital display<br>pedestal with extension |
| Power Frequency | 50/60 Hz | 50/60 Hz |
| Power | $\leq 250 W$ | $\leq 280 W$ |
| Warming Up Time | 15 minutes | 15 minutes |
| Total Working<br>Hours | 1,200 to 1500 hours | 1,000 hours |
| Operating Timer | Up to 60 minutes | Up to 95 minutes |
| Number of<br>heating head | 1 | 3 |
| Number of Fuse | 2 | 2 |
| Inner Cover<br>Diameter | 12 cm | 8 cm |
| Number of Casters | 4 | 5 |

| Spectrum Ranges<br>State I | 2 to 50 microns | | | 5 to 25 microns | | |
|-------------------------------------|------------------------------------------------|------|------|-----------------|------|------|
| Skin Temperature<br>State I<br>(°C) | The distance from the lamp head and the result | | | | | |
| | 8" | 10" | 12" | 8" | 10" | 12" |
| | 45°C | 43°C | 41°C | 44°C | 42°C | 41°C |

| Spectrum Ranges<br>State II | 2 to 50 microns | | | 2 to 50 microns | | |
|------------------------------|------------------------------------------------|------|------|-----------------|------|------|
| Skin Temperature<br>State II | The distance from the lamp head and the result | | | | | |
| | 8" | 10" | 12" | 8" | 10" | 12" |
| (°C) | 45°C | 43°C | 41°C | 47°C* | 44°C | 43°C |

*47°C exceeds the safe temperature range and that model CQ-55A should be positioned at least 10 inches from the body surface to be treated.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

JUN 6 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Chongqing Xinfeng Medical Instrument Company, Ltd. C/o Mr. George Su Crosslinks International, Inc. 1800 Century Park East, Suite 600 Century City, California 90067

Re: K043558

- K043338
Trade/Device Name: Xinfeng Heat Lamps, Models CQ-27, CQ-36, CQ-55A Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: May 26, 2005 Received: May 26, 2005

Dear Mr. Su:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosulty to regally manced provice Amendments, or to commerce prior to May 28, 1776, the enatified in accordance with the provisions of the Federal recognities (1)MAA devices that have been icclassince in acceracy in of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appli and Cosmelle Act (Act) that do not require approvine of the general controls provisions of the Act. The You may, therefore, market the device, belyer to the one of the only and registration, listing of general Controls provisions of the Procession, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classince (secure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major research and like o may be subject to such additional bonnons. Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of I casial Hegening your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of a backed on a complies with other requirements of the Act
that FDA has made a determination that your device complies with other re that I DA has made a decemination administered by other Federal agencies. You must of any Pederal Statutes and regulations daministers of 5 mot limited to: registration and issting (21 comply with an the Act 3 requirements, mercesses and actually of the requirements as set CFR Fart 807), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

Page 2 – Mr. George Su

This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to oegin manceing your artial equivalence of your device to a legally premarket notheadon: "The FDA miaing of castion 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 If you desire specific advice for your ac-1100 cm on one one the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regulation en Colliact the Office of Comphalled at (210) = 16 = 21 807.97). You may obtain Misoranding by reference to premailson ibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204 or Manufacturers, international and Oolisal http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Az. S. Rhodes
Miriam C. Provost, Ph.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Ko455556
Additional Information for Xinfeng Heating Lamp

# Indications for Use

510(k) Number (if known): ___K043558__

Infrared Lamp Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Xinfeng Heating lamp, including CQ-27, CQ-36 and CQ-55A, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of
lamp that emits the infrared spectrum to provide topical heating and to lamp that emiss the mirated spectrain to from the reseal blood circulation, and to elevaling tissue temperature, to temporarily mercule stiffees. The lamps may also help
temporarily relieve minor muscle and joint pain and strains and strains, and temporarily relieve intor muscle and joint pain and strains and strains and strains, and minor muscular back pain.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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 of Device Evaluation (ODE)

Hytk. Loodu

Division Sion-Division of General, Restorative, and Neurological Devices

KOYJ558 510(k) Number_

5

Page 1 of 1_