EPIX XL TENS UNIT

K951903 · Empi · GZJ · Mar 20, 1996 · Neurology

Device Facts

• Record ID: K951903
• Device Name: EPIX XL TENS UNIT
• Applicant: Empi
• Product Code: GZJ · Neurology
• Decision Date: Mar 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Epix XL TENS Unit is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.

Device Story

Epix XL Model 995 is a dual-channel Transcutaneous Electrical Nerve Stimulator (TENS) for pain management. Device delivers Empi Bi-Sourced® symmetrical, bi-phasic electrical waveforms via cutaneous electrodes. Operates via 9V battery; features four conventional modes and eight pre-programmed regimens. User selects output levels (0-40mA or 0-60mA). Includes an output interlock safety feature to prevent sudden current increases. Intended for clinical or home use; operated by patient or clinician. Output provides symptomatic relief for chronic, intractable, post-surgical, or post-trauma pain.

Clinical Evidence

No clinical data. Bench testing performed against product specifications confirmed the device meets requirements and is acceptable for its intended use.

Technological Characteristics

Dual-channel TENS unit; ABS plastic housing; 9V battery powered. Microprocessor-controlled (masked). Waveform: Symmetrical, bi-phasic. Output: 0-40Vpp or 0-60Vpp; pulse width 0-400μs. Standards: AAMI/ANSI NS4-1985, IEC 601-2-10, IEC 601-1-2. Features output interlock for safety. Dimensions: 3.7in x 2.5in x 0.84in; weight 145g.

Indications for Use

Indicated for symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain in patients requiring TENS 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

• Empi Epix XL Model 989

Submission Summary (Full Text)

{0}

5951903

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant name: | Empi, Inc. | MAF 20 1996 |
| --- | --- | --- |
| Applicant address: | 5255 East River Rd.
Fridley, MN 55421 | |
| Contact person: | Stacy Mattson, Regulatory Affairs Manager | |
| Phone: | 612-586-7354 | |
| Date Prepared: | April 11, 1995 | |
| Classification Name: | Transcutaneous Electrical Nerve Stimulator | |
| Common/Usual Name: | TENS unit | |
| Trade/Proprietary Name: | Epix XL TENS Unit, Model 995 | |
| Equivalent Devices: | Empi Epix XL Model 989 | |

## Product/System Description

The Epix XL is a dual channel TENS device with four conventional modes of operation, eight pre-programmed regimens and a choice of two levels of output (0-40mA or 0-60mA). It is powered by a standard 9V alkaline or NiCad rechargeable battery. All operation modes produce the Empi Bi-Sourced® waveform.

The Epix XL System requires the use of a set of leadwires and one or two pair of cutaneous stimulation electrodes.

## Intended Use:

The Epix XL TENS Unit is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.

## Comparison of Equivalent Devices to the New Device:

### Summary of Technical Differences

The Epix XL Model 995 is technically identical to the Epix XL 989 with the exception of a change in the LED lights from red to green. No testing is needed to establish equivalence.

### Summary of Performance - Nonclinical

The Epix XL Model 995 performs identically to the Epix XL Model 989 with the exception of an added function to prevent the stimulator from delivering current from a no output condition (no battery or device is turned OFF) to a rapid increase in current (fresh battery without turning the device OFF or manually turning the potentiometer up too quickly from start up of the device). This is an added feature which is required to meet international device standards. This function does not impact the performance of the device, thus does not require clinical testing to establish equivalence.

## Product Verification and Validation

The functional testing was performed and the results analyzed against product specifications demonstrating that the product meets requirements and is acceptable for its intended use.

Page 1 of 3

{1}

COMPARISON OF PRODUCT SPECIFICATIONS

The Epix XL Model 995 is substantially equivalent to the Epix XL Model 989. The similarities in the two products can be seen in the following chart.

| Product Characteristics | Epix XL Model 989 | Epix XL Model 995 |
| --- | --- | --- |
| Indications for Use | Symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post trauma acute pain. | Symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post trauma acute pain. |
| No. Of Output Channels | 2 | 2 |
| Standards | AAMI/ANSI NS4-1985
IEC 601-2-10
IEC 601-1-2 | AAMI/ANSI NS4-1985
IEC 601-2-10
IEC 601-1-2 |
| Control mechanism | Microprocessor, masked | Microprocessor, masked |
| Amplitude (voltage) Range | 0-40Vpp (normal)
0-60Vpp (high) | 0-40Vpp (normal)
0-60Vpp (high) |
| Maximum Output Voltage | 120Vpp, 1MΩ | 120Vpp, 1MΩ |
| Channel Interaction | ≤ 5% | ≤ 5% |
| Pulse Width | 0-400μs at 50% of peak amplitude | 0-400μs at 50% of peak amplitude |
| Waveform | Symmetrical, bi-phasic | Symmetrical, bi-phasic |
| Zero Net DC | yes; achieved through the transformer | yes; achieved through the transformer |
| Max. Charge per Pulse | 20μC into a 500 Ohm load | 20μC into a 500 Ohm load |
| Adjustable Pulse Rates | 2, 10, 20, 40, 60, 80, 100, 150 Hz | 2, 10, 20, 40, 60, 80, 100, 150 Hz |
| Standard Output Modes* | Continuous (C), Burst (B), Modulated Rate (R), Multi-Modulated (M) | Continuous (C), Burst (B), Modulated Rate (R), Multi-Modulated (M) |
| Preprogrammed Output Modes* | Extremely Low Frequency (ELF)
Dual Pulse (DP)
High Frequency (HF)
Bi-Modal (BM)
Ramped Burst (RB)
Modulated Amplitude (MA)
Alternating Ramped Burst (ARB)
Random Modulation (RAM) | Extremely Low Frequency (ELF)
Dual Pulse (DP)
High Frequency (HF)
Bi-Modal (BM)
Ramped Burst (RB)
Modulated Amplitude (MA)
Alternating Ramped Burst (ARB)
Random Modulation (RAM) |
| High Amplitude Shutdown (Output Interlock) | No | Yes |
| Housing Materials | ABS Plastic | ABS Plastic |
| Output Type | constant voltage
200Ω - 1kΩ | constant voltage
200Ω - 1kΩ |
| Minimum Electrode Size (active area) | NeuroEase .25in² (1.6cm²) | NeuroEase .25in² (1.6cm²) |
| Maximum RMS Current Density | 30.9mA/in²
(4.88mA/cm²) | 30.9mA/in²
(4.88mA/cm²) |

Page 2 of 3

{2}

Comparison of Product Specifications (cont.)

| Product Characteristics | Epix XL Model 989 | Epix XL Model 995 |
| --- | --- | --- |
| Maximum Power Density | 243 W/in2 (38 mW/cm²) | 243 W/in2 (38 mW/cm²) |
| Maximum Average Phase Current (specify load) | 77mA, 200Ω load | 77mA, 200Ω load |
| Maximum Enclosure Leakage Current | 100μA | 100μA |
| Automatic Overload Trip | NA | NA |
| Automatic No Load Trip | NA | NA |
| Patient Override Control | NA | NA |
| Max. Patient Leakage Current | 100μA | 100μA |
| Output Indicator | YES red | YES-green |
| Low Battery Indicator | YES, yellow | YES, yellow |
| Size | 3.7in.x2.5in.x0.84in. | 3.7in.x2.5in.x0.84in. |
| Weight | 145 gm with battery | 145 gm with battery |
| Power Source | 9 V Alkaline Battery or equivalent Empi rechargeable battery | 9 V Alkaline Battery or equivalent Empi rechargeable battery |

The shaded areas show where there are differences between the two devices.

Page 3 of 3