(29 days)
Not Found
No
The description focuses on programmable parameters and pre-defined programs, with no mention of AI/ML terms or capabilities.
Yes
The device is intended for "symptomatic relief of chronic intractable pain," which is a therapeutic purpose.
No
The device is described as a "Microcurrent Stimulator" and "Microcurrent TENS device" intended for "symptomatic relief of chronic intractable pain." Its function is to "generate low current intensity pulses," which falls under therapeutic stimulation, not diagnosis. There is no mention of it being used to identify or analyze a medical condition.
No
The device description explicitly states it is a "Microcurrent TENS device" and describes its ability to "generate low current intensity pulses," which are hardware functions. While software is mentioned for verification, the core function involves physical 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 of chronic intractable pain." This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a "Microcurrent TENS device" that generates electrical pulses. This is consistent with a physical therapy or pain management device, not a device used to test samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to apply electrical stimulation to the body for pain relief.
N/A
Intended Use / Indications for Use
Inspirstar IS02 Microcurrent Stimulator is intended to be used for the symptomatic relief of chronic intractable pain.
Product codes
GZJ
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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L060368
Section 5
510(k) Summary
Inspirstar IS02 Microcurrent Stimulator - TENS Device
-
- 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.
-
- Intended Use
Inspirstar IS02 Microcurrent Stimulator is intended to be used for the symptomatic relief of chronic intractable pain.
- Intended Use
-
- Legally Marketed Predicate Devices
Inspirstar IS02 Microcurrent Stimulator is substantially equivalent to the following predicate device. See Table 5-1 Predicate Devices.
- Legally Marketed Predicate Devices
1
| Device Name | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| THERASTIM (also known | |||
| as "Precision Micro") | Precision Electronics, | ||
| Ltd. | K914813 | 12/31/1991 | |
| "ALPHA-STIM CS" | |||
| ("Alpha-Stim 100" is | |||
| registered as update.) | Electromedical | ||
| Products, Inc. | K896948 | 02/23/1990 |
Table 5-1 Predicate Devices
-
- 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.
- Substantial Equivalence Summary
-
- 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.
- Technological Characteristics
-
- 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.
- Performance Data
-
- Conclusions
Inspirstar IS02 Microcurrent Stimulator is substantial equivalent to legally marketed predicative devices.
- Conclusions
2
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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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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.