(358 days)
K 022888
K 022888
No
The summary describes a simple LED-based topical heating device and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is indicated for therapeutic purposes such as pain relief, relaxation, and increasing blood circulation, which are all therapeutic effects.
No
The device is for therapeutic heating and pain relief, not for diagnosing conditions.
No
The device description explicitly states it is a "lamp" that generates red light using LEDs, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies energy to the body for therapeutic purposes (heating tissue, relieving pain, increasing blood circulation). This is a physical therapy or pain management application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a lamp emitting red light. This is consistent with a light therapy device, not an IVD which would typically involve reagents, analyzers, or other components for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The AIRNERGY+® Stream is indicated for use to emit energy to provide topical heating for the purposes of elevating tissue tem-perature for temporary relief of minor muscle and joint pain, tem-porary relief of minor arthritis pain and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to tempora-rily increase local blood circulation where applied.
Product codes
ILY
Device Description
Like the predicate devices the AIRNERGY+® Stream is a lamp that has the same indication for use and equivalent technology.
The device electrical and mechanical design is for use and convenience of the users. The red light is generated by LEDs (light emitting diodes) at a wave range between 600 and 650 nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Tests have proven that the AIRNERGY+® is safe and effective with respect to its intended use and does not depict any risk to the user.
The AIRNERGY+® Stream is designed, labeled, and verified for performance and safety. Performance data has proven that it performes safe and effectively with respect to its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 022888
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.
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| 510 (k) Summary of safety and effectiveness | |
|---|---|
| Applicant: | natural energy solutions AG |
| Reisertstraße 21 | |
| 53773 Hennef, Germany | |
| Phone No.: +49 (22 42) 9330-0 | |
| Fax No.: +49 (22 42) 9330-30 | |
| E-mail: info@nes-ag.com | |
| SEP - 5 2006 | |
| Establishment registration number | 3004139830 |
| Name of contact | Dr. Martina Günderoth, MBA |
| Eisenhutweg 15 | |
| 84036 Kumhausen-Preisenberg, Germany | |
| Phone No.: ++49 871 430 8378 | |
| Fax No.: ++49 871 430 8379 | |
| E-mail: mguenderoth@onlinehome.de | |
| Proprietary name | AIRNERGY+®STREAM |
| Common name | AIRNERGY STREAM |
| Classification name | Infrared lamp. |
| Code of Federal Regulations | 21 CFR 890.5500 |
| Regulatory Class | Class II |
| Device panel / product code | Physical medicine / ILY |
| Predicate device | There are several infrared lamps known in the market. One of |
| these is the Acubeam of Light Force Therapy, Inc. (K 022888). | |
| Description of device | Like the predicate devices the AIRNERGY+® Stream is a lamp |
| that has the same indication for use and equivalent technology. | |
| 510(k) Summary | AIRNERGY+® Stream |
| The device electrical and mechanical design is for use and | |
| convenience of the users. The red light is generated by LEDs | |
| (light emitting diodes) at a wave range between 600 and 650 | |
| nm. | |
| Intended use | The AIRNERGY+® Stream is indicated for use to emit energy to |
| provide topical heating for the purposes of elevating tissue tem- | |
| perature for temporary relief of minor muscle and joint pain, tem- | |
| porary relief of minor arthritis pain and muscle spasm, relieving | |
| stiffness, promoting relaxation of muscle tissue, and to tempora- | |
| rily increase local blood circulation where applied. | |
| Voluntary standard | |
| compliance | - IEC 60601-1 |
- IEC 60601-1-2 |
| | Tests have proven that the AIRNERGY+® is safe and effective
with respect to its intended use and does not depict any risk to
the user. |
| Conclusions | The AIRNERGY+® Stream is designed, labeled, and verified for
performance and safety. Performance data has proven that it
performes safe and effectively with respect to its intended use.
It conforms to applicable ISO standards.
It has the same indication for use and same technology as the
predicate devices. |
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Natural Energy Solutions AG, Hennef/Germany 1.4/0806
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Natural Energy Solutions AG, Hennef/Germany 1.4/0806
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle with three lines forming its body and head. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Natural Energy Solutions AG % C.R.C. Martina Gunderoth, MBA Regulatory Affairs Manager Eisenhutweg 15 84036 Kumhausen-Preisenberg Germany
SEP - 5 2006
Re: K052492
Trade/Device Name: AIRNERGY+® STREAM Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: June 20, 2006 Received: June 27, 2006
Dear Dr. Gunderoth:
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 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 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 (OS) 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 - Martina Gunderoth, MBA
This 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely y
Tor
Mark N. Mölke
Mark N. Melkerson Director C Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 1