(374 days)
Not Found
No
The summary describes a device that provides infrared light therapy and can be used with other electrical stimulation devices. There is no mention of AI or ML in the intended use, device description, or the specific sections for AI/ML information.
Yes
The device is described as providing "topical heating" for "temporary relief of minor muscle and joint aches," "temporary relief of pain and stiffness," and "relaxation of muscles," which are all therapeutic claims. It also explicitly states it can be used with "legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy" which are therapeutic devices.
No
The device is described as a therapy system for pain relief, muscle relaxation, and increased circulation through topical heating, not for diagnosing conditions.
No
The device description explicitly mentions "light heads" and the ability to "shine its IR light," indicating a hardware component that emits infrared light for therapy. This is not a software-only 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 therapeutic device used for topical heating to relieve pain, stiffness, and muscle issues. This is a physical therapy application, not a diagnostic test performed on samples from the human body.
- Device Description: The device description focuses on infrared light therapy and its use with electrodes for physical therapy modalities like TENS and muscle stimulation. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for therapeutic purposes, not diagnostic ones.
N/A
Intended Use / Indications for Use
Electro-Light Therapy System is used to provide topical heating for:
- Temporary increases in local blood flow and circulation.
- Temporary relief of minor muscle and joint aches
- Temporary relief of pain and stiffness
- Relaxation of muscles
- Temporary relief (or relaxation) of muscle spasms
- Temporary relief of minor pain and stiffness associated with arthritis.
The Electro-Light Therapy system is intended to be used alone or at the same time with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy when used with the transparent Electro-Light electrode.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The Electro-Light Therapy is designed to comply with the following Consensus Standards: IEC 60601-1 +A1, +A2 Medical Electrical Equipment- Part 1: General Requirements for Safety.
The Electro-Light Therapy offers similar infrared therapy to the K072256 predicate device. The IR Light covered by K072256 allowed the operation of only one light head. The Electro-Light Therapy can support up to 4 light heads each with a similar intensity to the predicate K072256.
The significant difference between the Electro-Light Therapy device and the Terraquant Mg2000 V.5 With the Tq-1 Tens is that the predicate device K071445 is equipped with an on-board TENS stimulator. The Electro-Light Therapy device does not have a built-in TENS stimulator.
The Electro-Light Therapy device can shine its IR light through the optional transparent gel electrodes. In the case of the predicate K071445, the electrode is an annular gel electrode ring attached to the front of the IR applicator and light can shine through the middle of the electrode ring. The Electro-Light Therapy is intended be used with any legally marketed TENS, interferential, or powered muscle stimulator. The IR and visible light will pass through a clear gel electrode. The gel electrode was cleared under K072256. Like the predicate devices, the Electro-Light Therapy is intended to be used only by a qualified therapist.
Both the predicate devices and the new device are intended to be used on a cart.
The primary difference between the new device and the predicate K072256 is that the predicate has a setting that allows continuous IR output whereas the new device has a maximum time setting of 99 minutes. This is not considered to be significant.
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
qualified therapist
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
IC090250
510(k) SUMMARY
For Hill Laboratories Electro-Light Therapy
FEB 1 1 2010
. . . .
1. Submitter's Name and Address
| Submitter's Name: | Hill Laboratories |
|---|---|
| Address: | 3 Bacton Hill Rd |
| City, State, and Zip: | Frazer, PA 19355 |
2. Contact Person
| Name: | Brady Aller |
|---|---|
| Title: | Sales/Service Manager |
| Telephone: | (610) 644-2867 |
| Facsimile: | (610) 647-6297 |
| E-mail: | bradyaller@hilllabs.com |
3, Manufacturing Facility Address
| Manufacturer: | Hill Laboratories |
|---|---|
| Address: | 3 Bacton Hill Rd |
| City, State, and ZIP: | Frazer, PA 19355 |
4. Establishment Registration Number
Establishment Registration Number: 2510425
5. Reason for Submission
Reason for Submission: New Device
6. Date of Summary Preparation
Date of Summary Preparation: January 26, 2009
7. Device Details
Proprietary or Trade Name: Electro-Light Therapy Infrared lamp Common Name:
1
Device Common Name, Classification, Product Code & 8. CFR No.
| Acres of the complex
ommon Name | of the control of the property | ﺍﺯ ﺍﯾﺮﺍﻥ
ባለው | CITY |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------|--------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
LINER FOR AND AND ANDRE
n tranda
12mm
1 | 1
------------------------------------- | 1 | ------------------------------------
890 5500 |
9. Classification Name
lamp, infrared, therapeutic heating
Device Classification Panel 10.
Physical Medicine
11. Indications for Use
Electro-Light Therapy System is used to provide topical heating for:
- Temporary increases in local blood flow and circulation .
- . Temporary relief of minor muscle and joint aches
- . Temporary relief of pain and stiffness
- . Relaxation of muscles
- . Temporary relief (or relaxation) of muscle spasms
- Temporary relief of minor pain and stiffness associated with arthritis .
The Electro-Light Therapy system is intended to be used alone or at the same time with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy when used with the transparent Electro-Light electrode.
Standards 12.
Mandatory Standards 12.1
There are no mandatory standards for the type of device contained in this 510(k).
12.2 Consensus Standards
The Electro-Light Therapy is designed to comply with the following Consensus Standards:
| STANDARD NO. | TITLE |
|---|---|
| IEC 60601-1 +A1, +A2 | Medical Electrical Equipment- Part 1: General Requirements for |
| Safety |
2
13. Predicate Devices
| 510(k) Number | Trade or Proprietary or Model
Name | Manufacturer | Class |
|---------------|---------------------------------------------|-----------------------|-------|
| K072256 | HF 54 with Optional Hands-free
operation | Hill Laboratories | 2 |
| K071445 | Terraquant Mq2000 V.5 With
The Tq-1 Tens | Medical Quant
LTD. | 2 |
Substantial Equivalence (SE) Rationale 13.1
13.1.1 Technology
The Electro-Light Therapy offers similar infrared therapy to the K072256 predicate device. The IR Light covered by K072256 allowed the operation of only one light head. The Electro-Light Therapy can support up to 4 light heads each with a similar intensity to the predicate K072256.
The significant difference between the Electro-Light Therapy device and the Terraquant Mg2000 V.5 With the Tq-1 Tens is that the predicate device K071445 is equipped with an on-board TENS stimulator. The Electro-Light Therapy device does not have a built-in TENS stimulator.
The Electro-Light Therapy device can shine its IR light through the optional transparent gel electrodes. In the case of the predicate K071445, the electrode is an annular gel electrode ring attached to the front of the IR applicator and light can shine through the middle of the electrode ring. The Electro-Light Therapy is intended be used with any legally marketed TENS, interferential, or powered muscle stimulator. The IR and visible light will pass through a clear gel electrode. The gel electrode was cleared under K072256. Like the predicate devices, the Electro-Light Therapy is intended to be used only by a qualified therapist.
Both the predicate devices and the new device are intended to be used on a cart.
13.1.2 Standards
The Electrical Safety of the predicate device is consistent with FDA guidance and international standards. The new device is in compliance to the same standards.
13.1.3 Materials
The materials used in construction of the device, including the patient contacting parts and the method of information display are similar to the predicate cleared under .
13.1.4 Measured Parameters
The measured parameters for the proposed Electro-Light Therapy are the similar to those displayed on the device cleared under K072256.
3
13.1.5 Risk Analysis
The primary risks were identified as:
- . Temperatures in tissues above 45 °C
- . Patient falling asleep during treatment
Temperatures in Tissues 13.1.5.1
From Measurement, it was shown that the maximum temperature was 45 ℃ there is no new safety issue when compared with the K072256 predicate.
13.1.5.2 Patient falling asleep during treatment
The operator's manual requires that the operator remain in the same area as the patient and must monitor the patient to ensure that the patient has not fallen asleep.
The primary difference between the new device and the predicate K072256 is that the predicate has a setting that allows continuous IR output whereas the new device has a maximum time setting of 99 minutes. This is not considered to be significant.
13.2 Conclusion
The proposed Electro-Light Therapy when used as directed in the operator's manual presents no new safety or effectiveness concerns and is Substantially Equivalent to the IR therapy hand-piece cleared under K072256. The Electro-Light Therapy also has same characteristics of combined electrotherapy and IR therapy as the K071445 predicate.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Hill Laboratories % Mr. Brady Aller 3 Bacton Hill Road Frazer, PA 19355
Re: K090250
Trade/Device Name: Electro-Light Therapy Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: February 2, 2010 Received: February 3, 2010
FEB 1 1 2010
Dear Mr. Aller:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
5
Page 2 - Mr. Brady Aller
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications For Use statement
510(k) No. If known
Device Name:
Electro-Light Therapy
Indications For Use:
Electro-Light Therapy System is used to provide topical heating for:
- Temporary increases in local blood flow and circulation .
- . Temporary relief of minor muscle and joint aches
- . Temporary relief of pain and stiffness
- . Relaxation of muscles
- . Temporary relief (or relaxation) of muscle spasms
- . Temporary relief of minor pain and stiffness associated with arthritis
The Electro-Light Therapy system is intended to be used alone or at the same time with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy when used with the transparent Electro-Light electrode.
Prescription Use X (Per 21 CFR 801 Subpart D
Over-The-Counter Use
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation
AND/OR
luation (ODE)
FOR M.MEIKARS
Division Sign-Off
Division of Surgical, Orthopedic, 2 .d Restorative Devices
5 : 9(k) Number
Number K090250
Electro-Light Therapy 510(k)
January 26, 2009
Section 4-1