SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36

K991503 · United Pacific Co., Ltd. · ILY · Jul 28, 1999 · Physical Medicine

Device Facts

• Record ID: K991503
• Device Name: SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36
• Applicant: United Pacific Co., Ltd.
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To emit energy in the infrared spectrum to provide topical heating. Intended to use for the temporary relief of minor muscle and joint stiffness, temporary increase in local circulation where applied, and the relaxation of muscles.

Device Story

Sacred Crane TDP Lamp emits infrared energy for topical heating; used for temporary relief of minor muscle/joint stiffness, increased local circulation, and muscle relaxation. Device operates by applying heat to specific body areas. Used in clinical or home settings; operated by patients or healthcare providers. Output is thermal energy; affects clinical decision-making by providing non-invasive symptomatic relief for musculoskeletal conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infrared heat lamp; emits energy in the infrared spectrum for topical heating. No specific materials, connectivity, or software algorithms described.

Indications for Use

Indicated for patients requiring temporary relief of minor muscle and joint stiffness, temporary increase in local circulation, and relaxation of muscles.

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

JUL 28 1999

Mr. Daniel Ye Hua, MBA President United Pacific Company, Ltd. 219 South Raymond Avenue Alhambra, California 91801

K991503 Re: Trade Name: Sacred Crane TDP Lamp Regulatory Class: II Product Code: ILY Dated: April 24, 1999 Received: April 29, 1999

Dear Mr. Ye Hua:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Daniel Ye Hua, MBA

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely yours,

Neil R.P. Ogden

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

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510(k) Number (if known):_K991503

Device Name: SACRED CRANE TDP LAMP

Indications For Use:

To emit energy in the infrared spectrum to provide topical To emit energy in the infract bpood and the many temperature.

Intended to use for the temporary relief of minor muscle and joint stifthess, cemporary increase in local relief of minor strain spasm, cemporary increase a
circulation where applied, and the relaxation of muscles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ARO

| Division Sign-Off | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | K991503 |
| 510(k) Number | |

Prescription Use_
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)