(659 days)
No
The summary describes a standard electrical stimulator and explicitly states "Not Found" for mentions of AI, DNN, or ML.
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 applications.
No
Explanation: The device is described as an interferential stimulator with TENS indications used for pain relief, which is a therapeutic function, not a diagnostic one. It generates electrical pulses to activate nerves for pain management.
No
The device description explicitly states it "generates small pulses of electrical current" and is "delivered along lead cables to electrodes placed on your skin," indicating it includes hardware components for electrical stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for symptomatic relief and management of pain through electrical stimulation applied to the skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device generates electrical pulses to stimulate nerves. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, this device falls under the category of a therapeutic medical device, specifically an electrical stimulator, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This 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
Not Found
Device Description
The IF-4000 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activate underlying nerves. The relief from chronic and acute pain that the IF-4000 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
K95X683
APR - 1 199
EXHIBIT #11 Page 1 of 3
510(K) SUMMARY APEX MEDICAL CORP.,
PORTABLE INTERFERENTIAL STIMULATION DEVICE
IF-4000
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K952683
1. Submitter's Identification:
Daniel Lee Apex Medical Corp. P.O. Box, 18-17 Taipei, Taiwan
Date Summary Prepared: December 30, 1996
2. Name of the Device:
IF-4000
3. Predicate Device Information:
IF-4150
4. Device Description:
The IF-4000 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activate underlying nerves. The relief from chronic and acute pain that the IF-4000 can provide results from this electrical stimulation.
5. Intended Use:
This 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.
1
EXHIBIT #11 Page 2 of 3
6. Comparison to Predicate Devices:
IF-4150 is with the timer and protection with high voltage. IF-4000 is without the timer and stable voltage. Please refer to chart below:
| BRAND NAME | IF-4000 | INF 4150/A |
|---|---|---|
| MAKER | APEX MEDICAL CORP. | BIOMEDICAL LIFE |
| SYSTEMS, INC. | ||
| 510(K) NUMBER | K952683 | K921441 |
| CARRIER FREQUENCY | 4000 Hz, fixed | 4000 Hz, fixed |
| DIFFERENCE | ||
| FREQUENCY | 1-150 beats per second, | |
| adjustable | 1-150 beats per second, | |
| adjustable | ||
| OUTPUT CURRENT | 0-29 milliamps, | |
| adjustable | 0-50 milliamps, | |
| adjustable | ||
| OUTPUT VOLTAGE | 0-14.5 volts | |
| (29 volts peak to peak) | 0-25 volts | |
| (50 volts peak to peak) | ||
| WAVEFORM | symmetric bi-phasic | |
| square | symmetric bi-phasic | |
| square | ||
| PULSE WIDTH | 125 microseconds for | |
| each phase | 125 microseconds for | |
| each phase | ||
| MAX. CHARGE PER | ||
| CYCLE | 7.25 microcoulombs | 12.5 microcoulombs |
| POWER SOURCE | 9V alkaline battery or | |
| adapter | Four 1.5V alkaline | |
| batteries or optional wall | ||
| adapter | ||
| SIZE | 2.4" x 3.5" x 1.1" | 2.75" x 4.5" x 1.5" |
| FREQUENCY SHIFT | ||
| OPTION | Continuous, 1/1 abrupt, | |
| 8/8 abrupt, 10/10 | ||
| ramped | Continuous, 1/1 abrupt, | |
| 8/8 abrupt, 10/10 | ||
| ramped |
COMPARISON BETWEEN IF-4000 AND INF 4150/A
2
EXHIBIT #11 Page 3 of 3
Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:
The following non-clinical tests were performed and met required standards specifications:
- UL-544 a)
- AAMI/ANSI NS-4 Specifications for TENS Devices b)
- EMC Testing C)
- Allowable variations in supply voltage d)
- Patient Applied Risk Current e)
Discussion of Clinical Tests Performed: 8.
Non applicable.
9. Conclusions:
The IF-4000 is as safe as effective as the predicate - which is the INF-4150.