(282 days)
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Not Found
No
The summary describes a standard electrotherapy device (TENS, EMS, IF) and does not mention any AI or ML capabilities in the intended use, device description, or other sections.
Yes
Explanation: The device is indicated for symptomatic relief of pain, relaxation of muscle spasms, increasing local blood flow, preventing disuse atrophy, muscle re-education, and maintaining or increasing range of motion, all of which are therapeutic indications. It is also indicated for immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
No
This device is a therapeutic device (Electrotherapy Device) used for pain relief, muscle stimulation, and other physical rehabilitation purposes, not for diagnosing conditions.
No
The device description explicitly states "Electrotherapy Device (Combo Unit) Model 9612," indicating a physical hardware device that delivers electrical stimulation. The intended uses also describe applications of electrical stimulation, which requires hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described (pain relief, muscle stimulation, etc.) are all related to treating or managing conditions within the human body. IVDs, on the other hand, are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device is described as an "Electrotherapy Device (Combo Unit)". This type of device delivers electrical stimulation to the body, which is a therapeutic intervention, not a diagnostic test performed on a specimen.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TENS stands for Transcutaneous Electrical Nerve Stimulation. The device TENS system is used to provide Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.
EMS stands for Electrical Neuromuscular Stimulator. The device EMS system is indicated for:
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- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
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- Muscle re-education
-
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
IF stands for Interferential Stimulation. The device IF system is indicated for Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.
Product codes
IPF, GZJ, LIH
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
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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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
December 20, 2013
Guangzhou Finecure Medical Equipment Co., Ltd. c/o Field Fu Shenzhen ZYTC Consulting Co., Ltd. 05C Fuhai Kangle Building Nanshan District, Shenzhen China 518000
Re: K 130691
Trade Name: Electrotherapy Device (Combo Unit) Model 9612 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ, LIH Dated: October 4, 2013 Received: November 5, 2013
Dear Mr. Fu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
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, 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
1
Page 2 - Mr. Field Fu
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); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Joyce M. Whang -S
for Carlos L. Peña, PhD Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K130691
Device Name: Electrotherapy Device (Combo Unit) Model 9612
Indications For Use:
TENS stands for Transcutaneous Electrical Nerve Stimulation. The device TENS system is used to provide Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.
EMS stands for Electrical Neuromuscular Stimulator. The device EMS system is indicated for:
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
IF stands for Interferential Stimulation. The device IF system is indicated for Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/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 Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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