(91 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electrical stimulation, not AI/ML algorithms.
Yes
The device is described as an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and acute pain, which are therapeutic uses.
No
The device is described as an interferential stimulator used for pain relief, not for identifying or diagnosing a condition. Its function is to manage symptoms, not to detect or analyze health states.
No
The device description explicitly states that the device "generates small pulses of electrical current" and is "delivered along lead cables to electrodes placed on your skin," indicating it is a hardware device that produces electrical stimulation. The performance studies also mention testing in accordance with standards for electrical safety and electromagnetic compatibility, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an interferential stimulator with TENS indications for pain relief. This involves applying electrical stimulation to the body, which is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details how the device generates electrical pulses and delivers them through electrodes on the skin to activate nerves. This is consistent with a physical therapy or pain management device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.
Product codes
LIH
Device Description
The IF-100507 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activated underlying nerves. The relief from chronic and acute pain that the IF-100507 can provide results from this electrical stimulation.
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
Non-Clinical Tests Submitted: The IF-100507 has been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for safety of nerve and muscle stimulators. Accessories also meet safety requirements: 510(k) electrodes are specified, and the patient cable utilizes shrouded connectors to meet lead wire safety requirements. System level testing including waveform testing was performed in combination the IF-100507 stimulator.
Clinical Tests Submitted: None
Key Metrics
Not Found
Predicate Device(s)
APEX Interferential Current Therapy, IF-4000. K952683
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Ko70890
SUMMARY OF SAFETY AND EFFECTIVENESS for Interferential Current Therapy, IF-100507
JUN 2 9 2007
DATE OF SUBMISSION: February 15, 2007 EVERLIFE MEDICAL EQUIPMENT CO., LTD. SUBMITTER: NO 58, FU-CHIUN ST. HSIN-CHU CITY, CHINA (TAIWAN) 30067 TEL: 886-3-5208829 FAX:886-3-5209783
ESTABLISHMENT
REGISTRATION NO: 3004753827
OFFICIAL CONTACT: Dr. JEN, KE-MIN NO 58, FU-CHIUN ST. HSIN-CHU CITY, CHINA (TAIWAN) 30067 TEL: 886-3-5208829 FAX:886-3-5209783
TRADE NAME: EVERLIFE Interferential Current Therapy, IF-100507
COMMON/USUAL Interferential Current Therapy
NAME:
Interferential Current Therapy
NAME:
REGULATION NUMBER:
CLASSIFICATION
Pre-Amendment
PREDICATED DEVICE:
APEX Interferential Current Therapy, IF-4000. K952683
- INTENDED USE: The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.
$\frac{P}{M}$ 42 1/2
1
| Description of
Device: | The IF-100507 generates small pulses of electrical
current. Delivered along lead cables to electrodes
placed on your skin, these pulses pass through the
skin and activated underlying nerves. The relief from
chronic and acute pain that the IF-100507 can provide
results from this electrical stimulation. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Tests
Submitted: | The IF-100507 has been tested in accordance with
applicable standards for medical device electrical
safety, electromagnetic compatibility, and the
particular requirements for safety of nerve and muscle
stimulators.
Accessories also meet safety requirements: 510(k)
electrodes are specified, and the patient cable utilizes
shrouded connectors to meet lead wire safety
requirements.
System level testing including waveform testing was
performed in combination the IF-100507 stimulator. |
| Clinical Tests
Submitted: | None |
| Conclusion: | As the product description and tests as above, the
new device: EVERLIFE Interferential Current
Therapy, IF-100507 is as safe and effective as, and |
the function in a manner equivalent to the predicate device: APEX Interferential Current Therapy, IF-4000, K952683.
Thus the new device is substantially equivalent to the predicate devices in this aspect.
N ત્રીશ્ 7
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
JUN 2 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Everlife Medical Equipment Co., Ltd. % Ms. Shu-Chen Cheng 2064 Tamarin Drive Columbus. Ohio 43235
Re: K070890
Trade/Device Name: EVERLIFE Interferential Current Therapy, Model IF-100507 Regulatory Class: Unclassified Product Code: LIH Dated: May 23, 2007 Received: May 23, 2007
Dear Ms. Cheng:
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 (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.
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
3
Page 2 - Ms. Shu-Chen Cheng
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) 276-0120. 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 yours,
Fur
Mark N. Melkerson
Director
DEP DIASLON
Chalet
Division of General Restorative
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosurc
4
Indications for Use
510(k) Number:
K 070890
Device Name:
EVERLIFE Interferential Current Therapy, IF-100507
Indications for Use :
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
Number