(322 days)
Not Found
No
The device description and performance studies focus on basic electrical stimulation and safety standards, with no mention of AI or ML capabilities.
Yes
The device is described as an "ELECTRO-ACUPUNCTURE DEVICE" intended for "stimulation at hands of patient" for use in "the practice of acupuncture," which are therapeutic applications.
No
The device is described as an "ELECTRO-ACUPUNCTURE DEVICE" intended for "stimulation at hands of patient." Its function is to provide electro-acupuncture stimulation. There is no mention of diagnostic capabilities, such as measuring or analyzing physiological parameters to identify a condition or disease.
No
The device description explicitly states it consists of a battery-powered portable instrument, lead wires, and electrodes, indicating it is a hardware device with electrical components for 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 "ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture... intended for the stimulation at hands of patient." This describes a therapeutic or diagnostic device that interacts directly with the patient's body, not a device used to examine specimens derived from the human body.
- Device Description: The description details a device that delivers electrical stimulation through electrodes applied to the skin. This is consistent with an electro-acupuncture device, not an IVD which would typically involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any processes related to in vitro testing.
IVD devices are specifically designed to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to provide electrical stimulation for therapeutic or diagnostic purposes related to acupuncture.
N/A
Intended Use / Indications for Use
The intended use of ACULIFE/Model SMW-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
ACULIFE/model SMW-01 is intended for the stimulation at hands of patient.
Product codes
BWK
Device Description
The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting lead wire to two electrodes (one probe electrode and one big adhesive electrode) which make contact for hands stimulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands of patient
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)
- EN 60601-1 & EN 60601-1-1 for Electric Safety.
- EN 60601-1-2 for EMC.
- ISO 10993 for biocompatibility.
- Skin impedance test for the estimation of loading
- Output Characteristics testing for product specification.
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
N/A
0
510(k) SUMMARY
| submitters Information: | Inno-Health Technology, Inc.
8F-2, No.61, Kung Yi Road Sec. 2,
Taichung, Taiwan 408, Republic of China |
| ------------------------- | -------------------------------------------------------------------------------------------------------------- |
|---|
- Terry C. Chiang Contact Person: Tel: +886- 4 2327 0788
Date Summary Prepared. March 30, 2005
Device Information:
| Classification name: | Electro-Acupuncture. |
|---|---|
| Common / Usual name: | ACULIFE/Model SMW-01. |
| Classification: | Class II. |
| Regulatory Class: | Unclassified. |
| Product Code: | BWK. |
Substantial equivalence: S.H.P International / model ACUSTIM (510k number: K014237)
Description of the Device:
The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting lead wire to two electrodes (one probe electrode and one big adhesive electrode) which make contact for hands stimulation.
Indications For Use:
The intended use of ACULIFE/Model SMW-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
ACULIFE/model SMW-01 is intended for the stimulation at hands of patient.
Technological Characteristics:
ACULIFE uses a 9V/DC battery or 9V adaptor as the supply power of the stimulation unit. It can be adjusted for the output amplitude, keep the memory of chosen amplitude, and set the operation time. The electrode combination and lead wire provide the electro-acupuncture stimulation for hand by or on the order of a qualified practitioner of acupuncture as determined by the states.
1
Performance Data:
- EN 60601-1 & EN 60601-1-1 for Electric Safety. -
- EN 60601-1-2 for EMC. "
- ISO 10993 for biocompatibility. -
- Skin impedance test for the estimation of loading -
- Output Characteristics testing for product specification.
Statement of indication for use : See the following page.
Conclusion : Based on the documents provided in the 510(K) submission, the Inno-Health electrode acupuncture, model ACULIFE/ SMW-01 is substantial equivalent the chosen FDA cleared model : S.H.P International / model ACUSTIM.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes on its wing, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2006
Mr. Terry Chiang President Inno-Health Technology, Inc. 8F-2, No. 61, Kung Yi Road Section 2 Taichung, Taiwan 408 Republic of China
Re: K051197
Trade/Device Name: ACULIFE Model SMW-01 Regulation Name: Electro-Acupuncture Stimulator Regulatory Class: Unclassified Product Code: BWK Dated: January 12, 2006 Received: January 24, 2006
Dear Mr. Chiang:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic
3
Page 2- Mr. Terry Chiang
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hulut Semen
Mark N. Melkerson, M.S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K051197 ---
Device Name: Electro-Acupuncture; ACULIFE/Model SMW-01.
Indications For Use:
The intended use of ACULIFE/Model SMW-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
ACULIFE/model SMW-01 is intended for the stimulation at hands of patient.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Helglen
(Division Sign Off)
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number Ko 51197