K060158 · Auri-Stem Medical, Inc. · QJQ · Oct 13, 2006 · Neurology
Device Facts
Record ID
K060158
Device Name
NET-2000 MICROCURRENT STIMULATOR
Applicant
Auri-Stem Medical, Inc.
Product Code
QJQ · Neurology
Decision Date
Oct 13, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 882.5800
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Application of electrical current to the head to treat insomnia, depression, or anxiety.
Device Story
NET-2000 Microcurrent Stimulator is a precision electronic instrument for treating anxiety, depression, or insomnia. Device comprises a microprocessor-controlled box and silver, self-adhesive ear-clip electrodes. Operates by delivering low-intensity bipolar asymmetric rectangular electrical pulses (0-600 microamperes) to the head. Typically set at 0.5 Hz, with 1.5 Hz and 100 Hz options for physician use. Features a 50% duty cycle with 0 net current and a fixed 16.5-minute treatment timer. Designed for simple, self-administered use. Output provides therapeutic electrical stimulation intended to alleviate symptoms of the specified conditions.
Clinical Evidence
Bench testing only. Comparative performance testing against the predicate device (Alpha-Stim 100) demonstrated equivalence in electrical output and waveform characteristics. Electrical safety verified via EN60601-1 and EN60601-1-2 standards. Biocompatibility of patient-contacting electrodes confirmed through testing.
Technological Characteristics
Microprocessor-controlled electronic stimulator. Output: 0-600 microamperes, bipolar asymmetric rectangular waveform, 50% duty cycle, 0 net current. Frequencies: 0.5, 1.5, 100 Hz. Power: 9V battery. Electrodes: Silver, self-adhesive pads with conduction solution. Dimensions: 3.25" x 2" x 0.14". Weight: 3 oz. Safety standards: EN60601-1, EN60601-1-2.
Indications for Use
Indicated for the treatment of insomnia, depression, or anxiety in patients via application of electrical current to the head. No specific age or gender contraindications noted.
Regulatory Classification
Identification
A cranial electrotherapy stimulator is a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions.
Special Controls
In combination with the general controls of the FD&C Act, the virtual reality behavioral therapy device for pain relief is subject to the following special controls:
*Classification.* (1) Class II (special controls) when intended to treat insomnia and/or anxiety. The special controls for this device are:(i) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device to treat insomnia and/or anxiety.
(ii) Components of the device that come into human contact must be demonstrated to be biocompatible.
(iii) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC) in its intended use environment.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge, and energy, must be fully characterized and verified.
(vi) The labeling for the device must include the following:
(A) The intended use population and the intended use environment;
(B) A warning that patients should be monitored by their physician for signs of worsening;
(C) A warning that instructs patients on how to mitigate the risk of headaches, and what to do should a headache occur;
(D) A warning that instructs patients on how to mitigate the risk of dizziness, and what to do should dizziness occur;
(E) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;
(F) Instructions for use that address where to place the electrodes, what stimulation parameters to use, and duration and frequency of treatment sessions. This information must be based on the results of clinical studies for the device;
(G) A detailed summary of the device technical parameters, including waveform, output mode, pulse duration, frequency, train delivery, and maximum charge and energy; and
(H) Information on validated methods for reprocessing any reusable components between uses.
(vii) Cranial electrotherapy stimulator devices marketed prior to the effective date of this reclassification must have an amendment submitted to the previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
(2) Class III (premarket approval) when intended to treat depression.
(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 19, 2020, for any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 19, 2020, been found to be substantially equivalent to any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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Ko60158
## 510(k) Summary
Prepared 10-10-06 Auri-Stim Medical, Inc. 11272 Huron Street, #22 Northglenn, CO 80234 Phone 303-254-4206 Fax 303-457-4861 Contact: Lewis Ward
OCT 1 3 2006
Trade Name: NET-2000 Microcurrent Stimulator Common Name: Stimulator, Cranial Electrotherapy Classification: 21 CFR 882.5800 Product Code: JXK
The NET-2000 Microcurrent Stimulator is a precision electronic instrument used for the treatment of anxiety, depression, or insomnia. The treatment is simple and can easily be selfadministered.
The device consists of a microprocessor controller box and skin contact electrodes. The small controller box is a software controlled low-intensity output. Current ranges from 0-600 microamperes typically set at 0.5 Hz. Additional frequencies at 1.5 and 100 Hz are available for the physician's use. The waveform is a bipolar asymmetric rectangular shape. Duty cycle is 50% with a 0 net current. Timed treatment is set at 16.5 minutes.
The following comparison table demonstrates the NET-2000 equivalent to the predicate.
| Feature | NET-2000 | Alpha-Stim 100 |
|-------------------|---------------------------------------------|---------------------------------------------|
| Indication | Treats anxiety,<br>depression, and insomnia | Treats anxiety,<br>depression, and insomnia |
| Classification | CES, Class III<br>Prescription, 882.5800 | CES, Class III<br>Prescription, 882.5800 |
| Contraindications | None | None |
| Power Source | 9 volt battery | 9 volt battery |
| 510(k) | This submission | K903014 |
| Size | 3.25" x 2" x .14" | 13.5cm x 6.4cm x 3.3cm |
| Weight | 3 oz. | 5.5 oz. |
| Current | 0-600 microamperes | 10-600 microamperes |
### COMPARISON TABLE, Microcurrent Stimulator
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| Frequency | 0.5, 1.5, 100 Hz | 0.5, 1.5, 100 Hz |
|--------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Waveform | Bipolar asymmetric rectangular waves<br>50% duty cycle, 0 net<br>current | Bipolar asymmetric rectangular waves<br>50% duty cycle, 0 net<br>current |
| Electrodes | Silver, self adhesive pads<br>with conduction solution,<br>clip style. Applied to ear<br>lobes. | Silver, self adhesive pads<br>with conducting solution,<br>clip style. Applied to ear<br>lobes. |
| Timer Treatment Settings | 16.5 minutes | 10, 20, 60 minutes and<br>continuous |
Performance testing is confirmed by a comparative testing to the Alpha-Stim 100 and demonstrates equivalence. Electrical safety is confirmed by testing and passing requirements under EN60601-1-2 and EN60601-1. Biocompatibility for the electrode patient contact is confirmed by testing.
The NET-2000 is safe and effective and does not introduce new questions of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# OCT 1 3 2006
L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado 80301
Auri-Stim Medical Inc.
% Mr. Lewis Ward
Re: K060158
Trade/Device Name: Net-2000 Microcurrent Stimulator Regulation Number: 21 CFR 882.5800 Regulation Name: Cranial Electrotherapy Stimulator Regulatory Class: Class III Product Code: JXK Dated: January 16, 2006 Received: January 20, 2006
Dear Mr. Ward:
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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 comply 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. Lewis Ward
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buchner
for
Mark N. N Aelkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### INDICATIONS FOR USE
#### KOGOISB 510(k)
Device Name: NET-2000 Microcurrent Stimulator
Indications for Use:
Application of electrical current to the head to treat insomnia, depression, or anxiety.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K060158
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
**510(k) Number** L060158
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
