(63 days)
Not Found
No
The summary describes a simple infrared heating lamp with basic controls and no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is intended to temporarily relieve minor muscle and joint pain and stiffness, increase local blood circulation, and alleviate pain associated with muscle spasms, sprains, strains, and muscular back pain, which are therapeutic claims.
No
The intended use statement describes functions related to providing topical heating and temporary pain relief, which are therapeutic rather than diagnostic purposes.
No
The device description clearly outlines physical hardware components such as a heating head, swing arm, control box, and pedestal, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an infrared lamp used for topical heating to elevate tissue temperature, increase blood circulation, and relieve pain. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the physical components and how it generates heat. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is a core function of IVDs.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples
- Detection or measurement of analytes
- Diagnostic claims
- Performance metrics like sensitivity, specificity, etc., which are crucial for evaluating diagnostic accuracy.
Therefore, the HUANQIU Heating lamp is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HUANQIU Heating lamp, including CQ-27, CQ-29 and CQ-67, 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.
Product codes
ILY
Device Description
The device 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 rare earth ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,000 to 1500 hours of usage. 110 volt power, 250 watts. There are two different types of control: standard control and digital display control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows the text "Crosslinks International, Inc." in a serif font. The text is arranged in two lines, with "Crosslinks" on the first line and "International, Inc." on the second line. The text is black and the background is white. The image appears to be a logo or heading from a document.
510 (k) Premarket Notification Summaries
Submission Correspondent
George Su, Ph.D. Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, CA 90067 USA
Tel: 310-229-5748 Fax: 310-388-1067 Email: crosslinks2000/a aol.com
Applicant:
A & A MEDICAL SUPPLIES INC 5288 valley blvd #1 Los Angeles, CA 90032
Tel: 323-223-6318
Sponsor of the 510(k) Submission:
Same as above.
Device Name:
Proprietary Name: HUANQIU Heating 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. Regulation Number: 890.5500 Product Code: ILY 510(k) Number: K003538 Registration Number: 1222811 Owner/Operator Number: 9003816
1
Crosslinks International, Inc.
Description of the HUANQIU Heating Lamps:
The device 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 rare earth ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,000 to 1500 hours of usage. 110 volt power, 250 watts. There are two different types of control: standard control and digital display control.
Indications for use
HUANQIU Heating lamp, including CQ-27, CQ-29 and CQ-67, 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
HUANQIU CQ-27, CQ-29 and CQ-67 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. HUANQIU Heating lamps are powered by 110V AC, They have 4 or 5 casters and 2 fuses. The working life of the heating plate is 1000 to 1500 hours. The skin temperature of the treatment area is at 40~45℃ when treating distances are from 8" to 12" from heating unit to treatment surface.
2
Crosslinks
International, Inc.
Table 1.
Predicate device: TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc.
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | The new device: HUANQIU Heating Lamp CQ-27 |
|---|---|
| and and and the commend the production of the first of the first of the first of the first of the first of the may |
| 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 | 2 to 50 microns | ||
| Warming Up Time | 15 minutes | 15 minutes | ||
| Total Working Hours | 1,200 to 1500 hours | 1,000 to 1500 hours | ||
| Operating Timer | Up to 60 minutes | Up to 60 minutes | ||
| Number of Fuse | 2 | 2 | ||
| Inner Cover Diameter | 12 cm | 12 cm | ||
| Number of Casters | 4 | 4 | ||
| Skin Temperature | The distance from the lamp head and the result | |||
| 8" | ||||
| 45°C | 10" | |||
| 43 °C | 12" | |||
| 41 °C | 8" | |||
| 45°C |
Table 2.
Predicate device: TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc. The new device: HUANQIU Heating Lamp CQ-29
| 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 |