INSPIRSTAR IS02 MICROCURRENT STIMULATOR

K060368 · Inspirstar, Inc. · GZJ · Mar 14, 2006 · Neurology

Device Facts

• Record ID: K060368
• Device Name: INSPIRSTAR IS02 MICROCURRENT STIMULATOR
• Applicant: Inspirstar, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Mar 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

Inspirstar IS02 Microcurrent Stimulator is intended to be used for the symptomatic relief of chronic intractable pain.

Device Story

The Inspirstar IS02 is a battery-powered, two-channel microcurrent transcutaneous electrical nerve stimulator (TENS). It generates low-intensity pulses at the microampere level. The device supports five pre-defined therapy programs, with parameters such as current intensity, frequency, and duration programmable by a physician. It is used for the symptomatic relief of chronic intractable pain. The device is operated by healthcare providers to configure treatment settings for patient use.

Clinical Evidence

Bench testing only. The device conforms to IEC 60601-1 (safety) and IEC 60601-1-2 (electromagnetic compatibility). Software verification was performed in accordance with FDA software guidance.

Technological Characteristics

Battery-powered, two-channel current source pulse generator. Features programmable frequency, current intensity, and pulse duration. Software-controlled. Conforms to IEC 60601-1 and IEC 60601-1-2 standards.

Indications for Use

Indicated for the symptomatic relief of chronic intractable pain in patients.

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

• THERASTIM (also known as "Precision Micro") (K914813)
• ALPHA-STIM CS ("Alpha-Stim 100") (K896948)

Submission Summary (Full Text)

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L060368

Section 5

# 510(k) Summary

### Inspirstar IS02 Microcurrent Stimulator - TENS Device

- 1. Submitters Identification

| a. Company Name: | Inspirstar Inc. |
|---------------------------------|-------------------------|
| b. Company Address: | 891 N. Naples Dr. |
| | Chandler, AZ 85226, USA |
| c. Contact Person: | Ning Wu, Vice President |
| d. Date of Summary Preparation: | January 20, 2006 |

### 2. Device Identification

| a. Common Name: | Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| b. Trade Name: | Inspirstar IS02 Microcurrent Stimulator |
| | Note: There might be two-letter suffix added to the model name |
| | "IS02" during marketing, like IS02AA, IS02AB. The names with different suffix are only for marketing and destination purpose and are the same products. |
| c. Classification: | Class II |

- Product Code: d. GZJ
- Regulation Number:882.5890 e.

### 3. Device Description

Inspirstar IS02 Microcurrent Stimulator is a Microcurrent TENS device intended to be used for the symptomatic relief of chronic intractable pain. This product can generate low current intensity pulses at microampere level and frequency of pulses. The unit supports five pre-defined therapy programs. The current intensity, frequency, time, etc. are programmable by doctors.

- 4. Intended Use
Inspirstar IS02 Microcurrent Stimulator is intended to be used for the symptomatic relief of chronic intractable pain.

- 5. Legally Marketed Predicate Devices
Inspirstar IS02 Microcurrent Stimulator is substantially equivalent to the following predicate device. See Table 5-1 Predicate Devices.

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| Device Name | Manufacturer | 510(k) No. | Date Cleared |
|-------------------------------------------------------------------|----------------------------------|------------|--------------|
| THERASTIM (also known<br>as "Precision Micro") | Precision Electronics,<br>Ltd. | K914813 | 12/31/1991 |
| "ALPHA-STIM CS"<br>("Alpha-Stim 100" is<br>registered as update.) | Electromedical<br>Products, Inc. | K896948 | 02/23/1990 |

Table 5-1 Predicate Devices

- 6. Substantial Equivalence Summary
Inspirstar IS02 Microcurrent Stimulator has the same indications for use as the legally marketed predicate device. Inspirstar IS02 Microcurrent Stimulator has same or comparable technological characteristics as the predicate device. Inspirstar IS02 Microcurrent Stimulator is substantially equivalent to legally marketed predicate devices.

- 7. Technological Characteristics
Inspirstar IS02 Microcurrent Stimulator has the same technological characteristics as all of the predicate devices. All are battery-powered, current source pulse generator devices with two output channels. Inspirstar IS02 Microcurrent Stimulator has very close waveforms and output characteristics including frequency, current intensity, wave slope, etc with Precision Micro ("THERASTIM") and has comparable waveforms and output characteristics with Alpha-Stim 100("ALPHA-STIM CS"). Inspirstar IS02 Microcurrent Stimulator and Alpha-Stim 100 are both software controlled. The user operating interfaces to setup values of frequency, current intensity, etc have some differences for three devices. But these differences do not affect the technology and do not affect the safety and effectiveness.

- 8. Performance Data
Inspirstar IS02 Microcurrent Stimulator conforms to applicable voluntary standards IEC 60601-1 for safety requirement, and IEC60601-1-2 for electromagnetic compatibility requirement. In addition, the software verification has been carried out according to FDA software guidance.

- 9. Conclusions
Inspirstar IS02 Microcurrent Stimulator is substantial equivalent to legally marketed predicative devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2006

Inspirstar Incorporated c/o Regulatory Technology Services LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K060368

Trade/Device Name: Inspirstar IS02 Microcurrent Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: March 2, 2006 Received: March 3, 2006

Dear Mr. Job:

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 r ou mayy ato s provisions of the Act include requirements for annual registration, listing of general vonaron provision 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 or any I 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.

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Page 2 - Mr. Mark Job

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence of your device to a legally 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Fiealth

Enclosure

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#### Section 4

## Indications for Use

K060368 510(k) Number (if known):

Device Name: Inspirstar IS02 Microcurrent Stimulator

Indications for Use:

Inspirstar IS02 Microcurrent Stimulator is intended to be used for the symptomatic relief of chronic intractable pain.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use ----------------------(21 CFR 801 Subpart C)

(PLEASE)DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH/ Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K060368 |
|---------------|---------|
|---------------|---------|

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INSPIRSTAR INC.