APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE

K952683 · Wholesale Medical Imports, Inc. · LIH · Apr 1, 1997 · Neurology

Device Facts

• Record ID: K952683
• Device Name: APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE
• Applicant: Wholesale Medical Imports, Inc.
• Product Code: LIH · Neurology
• Decision Date: Apr 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

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.

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.

Indications for Use

Indicated for symptomatic relief and management of chronic pain and adjunctive treatment of post-surgical and post-traumatic acute pain in patients requiring electrical stimulation therapy.

Regulatory Classification

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)

Submission Summary (Full Text)

{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.