(211 days)
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No
The provided text describes a standard electrical stimulator with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device applies electrical current to treat medical conditions like muscle spasms, disuse atrophy, and to prevent venous thrombosis, all of which are therapeutic interventions.
No
Explanation: The provided text describes the device's function as applying an electrical current for therapeutic purposes like muscle relaxation, prevention of disuse atrophy, and muscle re-education. It does not mention any function related to identifying, analyzing, or diagnosing medical conditions.
No
The intended use clearly describes applying an electrical current to electrodes on the patient's skin, which requires hardware (the electrical stimulator and electrodes) to deliver the therapy. This is not a software-only function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The intended use of this device is to apply electrical current to the patient's skin for therapeutic purposes (muscle stimulation, relaxation, etc.). This is a direct interaction with the patient's body, not the analysis of a specimen taken from the body.
- Lack of IVD Keywords: The description does not mention any terms related to laboratory testing, specimens, analysis of biological samples, or diagnostic information derived from such analysis.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Specific Indications: Used to apply an electrical current to electrodes on patients skin to function as:
- . Relaxation of muscle spasms.
- Prevention or retardation of disuse atrophy. .
- Muscle re-education. ●
- Immediate post-surgical stimulation of calf muscles to prevent venous . thrombosis.
- Maintaining or increasing range of motion. .
Clinical settings: The device should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
Product codes
IPF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Used under medical supervision.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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)
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§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Jen. Ke-Min Home Care Technology Co., Ltd. 116, Lane 523, Sec. 3 Jung Jeng Road Jen Ter Hsiang Tainan Hsien, Taiwan ROC 717
APR 0 8 2003
Re: K023001
Trade/Device Name: Homecare HT-326L Regulation Numbers: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: Class II Product Codes: IPF Dated: December 31, 2002 Received: January 8, 2003
Dear Dr. Jen, Ke-Min:
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 mav 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
1
Page 2 - Dr. Jen, Ke-Min
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours.
L. Mach X. Mellems
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number: K023001
Applicant: Home Care Technology Co., Ltd.
Device Name: Home Care HT-326L
Indications For Use:
Specific Indications: Used to apply an electrical current to electrodes on patients skin to function as:
- . Relaxation of muscle spasms.
- Prevention or retardation of disuse atrophy. .
- Muscle re-education. ●
- Immediate post-surgical stimulation of calf muscles to prevent venous . thrombosis.
- Maintaining or increasing range of motion. .
Clinical settings: The device should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| for (Division Sign-Off) Division of General, Restorative and Neurological Devices | |
|---|---|
| 510(k) Number | K02300 |
| Prescription Use
| (Per 21 CFR 801-109) | OR | Over-The-Counter |
|---|---|---|
| ------------------------------------------ | ---- | ------------------ |