(139 days)
Not Found
No
The document describes a standard electro-acupuncture device with variable frequency and intensity settings, similar to predicate devices. There is no mention of AI, ML, image processing, or data sets for training or testing, which are typically associated with AI/ML technologies in medical devices.
Yes
Explanation: The device is an electro-acupuncture device intended for use in the practice of acupuncture, which is a therapeutic modality.
No
The description explicitly states its intended use as an ELECTRO-ACUPUNCTURE DEVICE for acupuncture practice, not for diagnosis.
No
The device description explicitly states it is a "palm-size ELECTRO-ACUPUNCTURE DEVICE equipped with three independent output channels," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture." This describes a therapeutic or treatment device, not a device used to diagnose or test samples from the human body (which is the definition of an IVD).
- Device Description: The description focuses on the electrical stimulation aspects and features relevant to acupuncture treatment.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information.
Therefore, the ES-130 is an electro-acupuncture device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indication for use of ES-130 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Product codes (comma separated list FDA assigned to the subject device)
BWK
Device Description
ES-130 is a palm-size ELECTRO-ACUPUNCTURE DEVICE equipped with three independent output channels. This unit has incorporated similar features as the predicate devices such as:
- Variable Frequency Settings & Similar Frequency Range ●
- Variable Intensity Settings & Similar Output Range .
- . Biphasic Pulse Waveform
- . Similar Pulse Shape & Pulse Charge
- . Battery Power & Portability
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
Qualified practitioners of acupuncture
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)
Non-clinical verification and validation resting was conducted on ES-130 device, and the results of such testing appear in Section 18 of this submission. Clinical testing was neither required nor conducted regarding the ES-130 submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
伊藤超短波株式会社 CO,. LTD.
MANUFACTURERS & EXPORTERS established in 1916
NOV 2 4 2008
3-3-3 TOYOTAMA-MINAMI, NERIMA-KU, TOKYO,176-0014 JAPAN
K081943
510(k) Summary: Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination Regarding the ES-130 Electro-Acupuncture Device
| Submitter Name: | ITO CO., LTD. |
|---|---|
| 3-3-3 TOYOTAMA-MINAMI, NERIMA-KU | |
| TOKYO, 176-0014 JAPAN | |
| TEL: (+81) 3-3994-4619 | |
| FAX: (+81) 3-3994-8384 |
- KENNETH L. BLOCK, RAC Contact Name:
- Date Prepared: September 30, 2008
| Proprietary Name: | ES-130 |
|---|---|
| Primary Product Code: | BWK |
| Common Name: | Stimulator, Electro-Acupuncture |
| Class: | Unclassified |
| Predicate Devices: | K051197: ACULIFE/Model SMW-01 (Inno-Health Technology, Inc.) |
|---|---|
| K840983: Pulselife Model PL2 (Pulse Life) | |
| Pre-Amendment: Model WQ-10B (Danghua Electronic Instrument Factory) |
Device Description:
ES-130 is a palm-size ELECTRO-ACUPUNCTURE DEVICE equipped with three independent output channels. This unit has incorporated similar features as the predicate devices such as:
- Variable Frequency Settings & Similar Frequency Range ●
- Variable Intensity Settings & Similar Output Range .
- . Biphasic Pulse Waveform
- . Similar Pulse Shape & Pulse Charge
- . Battery Power & Portability
1
Using three similar predicate devices, detailed comparisons of specific ES-130 features and characteristics are contained in Section 8 of this submission, in accordance with the FDA publication Guidance Document for Powered Muscle Stimulator 510(k)s. This side-by-side comparison demonstrates that the performance characteristics of the predicate devices encompass the entire range of performance characteristics of the proposed ES-130 device including frequency values, output intensity values, number of channels, supply voltage value, pulse width value, pulse charge value, delivered current density, and delivered power density.
Indication for Use:
The indication for use of ES-130 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Cited Standards to Determine Substantial Equivalence:
ES-130 complies with FDA recognized standards IEC 60601-1-1, and IEC 60601-1-1, and IEC 60601-2-10. In addition, ES-130 complies with technical requirements outlined in 21 CFR 898.
Non-clinical Testing:
Non-clinical verification and validation resting was conducted on ES-130 device, and the results of such testing appear in Section 18 of this submission. Clinical testing was neither required nor conducted regarding the ES-130 submission. Form FDA-3674 is contained in Section 20 of this submission, which certifies compliance to FDA requirements regarding clinical data.
Truthful and Accuracy Statement:
Signed by a corporate management representative of the submitter, the required statement attesting to the truthfulness and accuracy of the information contained in Section 6 of this submission.
Further Information:
Please contact the following individual to request any further information regarding this submission:
Kenneth L. Block, RAC Official Correspondent (ITO CO., LTD.) Ken Block Consulting 1201 Richardson Dr. Suite 140 Richardson, TX 75080 TEL: 972-480-9554 FAX: 972-767-4325 EMAIL: ken@kenblockconsulting.com
2
Public Health Service
Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ito Co., Ltd. % Ken Block Consulting Mr. Kenneth L. Block, RAC Certified Regulatory Consultant 1201 Richardson Dr., Suite 140 Richardson, Texas 75080
NOV 2 4 2008
Re: K081943
Trade/Device Name: Model ES-130 Electro-Acupuncture Device Regulation Name: Electro-Acupuncture Stimulator Regulatory Class: Unclassified Product Code: BWK Dated: November 14, 2008 Received: November 17, 2008
Dear Mr. Block:
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. Ilsting 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.
3
Page 2 - Mr. Kenneth L. Block, RAC
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Mark M. Mulhern
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) number (if known): K
Device name: ES-130
Indication for Use:
The intended use of the ES-130 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
X
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
.
Prescription Use______________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDHR, Office of Device Evaluation (ODE)
FOR M. MELKERSON
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081943