(276 days)
Not Found
No
The summary describes a basic electro-acupuncture device with no mention of AI, ML, or any related technologies. The performance studies listed are standard electrical safety and biocompatibility tests, not AI/ML performance metrics.
Yes
The device is described as an "ELECTRO-ACUPUNCTURE DEVICE" intended for "stimulation" in the practice of acupuncture, which falls under the definition of therapeutic intervention.
No
The device is described as an "ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture" and is "intended for the stimulation at hands of patient." Its purpose is therapeutic stimulation, not diagnosis.
No
The device description explicitly states it consists of a "battery powered portable instrument" with "conducting lead wire" and "two electrodes," indicating it is a hardware device.
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... 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 (like blood, urine, or tissue) outside of the body.
- Device Description: The description details electrodes that make contact with the patient's hands for stimulation. This aligns with an electro-acupuncture device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, based on the provided text, the ACULIFE/Model IDOC-01 is an electro-acupuncture device, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of ACULIFE/Model IDOC-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 IDOC-01 is intended for the stimulation at hands of patient.
Product codes (comma separated list FDA assigned to the subject device)
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
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. -
- Output Characteristics testing for product specification. -
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
510(k) SUMMARY
. . •
Inno-Health Technology, Co., Ltd. submitters Information: 8F-2. No.61. Kung Yi Road Sec. 2, Taichung, Taiwan 408, Republic of China
APR - 2 2010
Terry C. Chiang Contact Person: Tel: +886- 4 2327 0788
Date Summary Prepared: June 20, 2009
Device Information:
| Classification name: | Electro-Acupuncture. |
|---|---|
| Common / Usual name: | ACULIFE/Model IDOC-01. |
| Classification: | Class II. |
| Regulatory Class: | Unclassified. |
| Product Code: | BWK. |
Substantial equivalence: Inno-Health Aculife Electro-Acupuncture/ model SMW-01 (510K number: K051197)
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 IDOC-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 IDOC-01 is intended for the stimulation at hands of patient.
Technological Characteristics:
ACULIFE uses a 4.5V/DC battery or 5V 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. -
- 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 electrod-acupuncture, model ACULIFE/ IDOC-01 is substantial equivalent the chosen FDA cleared model : Inno-Health Aculife Electro-Acupuncture/ model SMW-01 (510K number: K051197).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract depiction of an eagle with three stylized wing segments, symbolizing service, science, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Inno-Health Technology, Co., Ltd. c/o Mr. Terry C. Chiang Official Correspondent 8F-2, No. 61, Kung Yi Road, Sec. 2 Taichung, Taiwan 408
Re: K091933
Trade/Device Name: ACULIFE Model IDOC-01 Regulatory Class: Unclassified Product Code: BWK Dated: March 5, 2010 Received: March 8, 2010
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 indictions 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
APR - 2 2010
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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, FDD mark 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 Isting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
A Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
Device Name: Electro-Acupuncture; ACULIFE/Model IDOC-01.
Indications For Use:
The intended use of ACULIFE/Model IDOC-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 IDOC-01 is intended for the stimulation at hands of patient.
Prescription Use __ V (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)-
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091933.
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