← Product Code [LIH](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LIH) · K952683 # APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE (K952683) _Wholesale Medical Imports, Inc. · LIH · Apr 1, 1997 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LIH/K952683 ## Device Facts - **Applicant:** Wholesale Medical Imports, Inc. - **Product Code:** [LIH](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LIH.md) - **Decision Date:** Apr 1, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5890 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## 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. ## Device Story Portable interferential stimulation device; generates electrical current pulses. Input: user-adjusted settings; Output: symmetric bi-phasic square wave electrical pulses delivered via skin-surface electrodes. Principle: electrical nerve stimulation for pain management. Operated by patient or clinician in clinical or home settings. Output affects nerve activity to provide pain relief. Device lacks timer and uses stable voltage compared to predicate. ## Clinical Evidence No clinical data. Substantial equivalence based on bench testing including UL-544, AAMI/ANSI NS-4, EMC testing, supply voltage variation, and patient applied risk current. ## Technological Characteristics Interferential stimulator; 4000 Hz fixed carrier frequency; 1-150 bps adjustable difference frequency; symmetric bi-phasic square waveform; 125 microsecond pulse width. Powered by 9V alkaline battery or adapter. Dimensions: 2.4" x 3.5" x 1.1". Complies with UL-544 and AAMI/ANSI NS-4 standards. ## Regulatory 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. ## Predicate Devices - INF 4150/A ([K921441](/device/K921441.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K952683 APR - 1 1997 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: COMPARISON BETWEEN IF-4000 AND INF 4150/A | 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 | {2} EXHIBIT #11 Page 3 of 3 7. **Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:** The following non-clinical tests were performed and met required standards specifications: a) UL-544 b) AAMI/ANSI NS-4 Specifications for TENS Devices c) EMC Testing d) Allowable variations in supply voltage e) Patient Applied Risk Current 8. **Discussion of Clinical Tests Performed:** Non applicable. 9. **Conclusions:** The IF-4000 is as safe as effective as the predicate - which is the INF-4150. --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LIH/K952683](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LIH/K952683) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com