APEX MEDICAL DIGITAL EMS TS1311, TS1312

• K Number: K021754
• Device Name: APEX MEDICAL DIGITAL EMS TS1311, TS1312
• Manufacturer: APEX MEDICAL CORP.
• Date Cleared: 2002-06-28 ( 30 days)
• Product Code: IPF
• Regulation Number: 890.5850

Intended Use

Apex Medical Digital EMS is intended to be used in: - 1. Relaxation of Muscle Spasm. - 2. Prevention or retardation of disuse atrophy. - 3. Increase local blood circulation. - 4. Muscle re-education. - 5. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis. - 6. Maintaining or increasing range of motion.

Device Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided 510(k) summary does not contain any mention of AI, ML, or related concepts, and the intended use and device description (though not found) do not inherently suggest the use of such technologies.

Therapeutic

Yes
The device aims to relax muscle spasms, prevent disuse atrophy, increase blood circulation, re-educate muscles, and prevent venous thrombosis, all of which are therapeutic applications.

Diagnostic

No
The "Intended Use / Indications for Use" section lists therapeutic applications (e.g., muscle relaxation, blood circulation, muscle re-education), not diagnostic purposes. It describes treating conditions rather than identifying or characterizing them.

SaMD (Software as a Medical Device)

Unknown

The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The intended use suggests a device that delivers electrical muscle stimulation (EMS), which typically requires hardware components to generate and deliver the electrical impulses. Without a description of the device's components, it's impossible to definitively say if it's software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Apex Medical Digital EMS is not an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended uses listed are all related to stimulating muscles and improving physical function. These are therapeutic applications, not diagnostic tests performed on samples taken from the body (like blood, urine, or tissue).
• Device Description: While the description is "Not Found," the intended uses clearly point to a device that interacts with the body externally for therapeutic purposes.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a disease or condition.

IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Apex Medical Digital EMS, based on its intended uses, falls under the category of a therapeutic medical device, likely an electrical muscle stimulator.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Apex Medical Digital EMS is intended to be used in:

• 1. Relaxation of Muscle Spasm.
• 2. Prevention or retardation of disuse atrophy.
• 3. Increase local blood circulation.
• 4. Muscle re-education.
• 5. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
• 6. Maintaining or increasing range of motion.

Product codes

IPF

Device Description

Not Found

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

Not Found

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)

Not Found

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.

Not Found

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

Not Found

Regulation Number and Section

§ 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).

Summary

0

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2002

Mr. Alan Chang Manager, Research and Development Apex Medical Corporation 10th Floor, No. 31, Lane 169 Kang-Ning St. Shi-Chih, Taipei Hsien Taiwan, R.O.C.

Re: K021754

Trade/Device Name: Apex Medical Digital EMS, models TS1311 and TS1312 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: May 27, 2002 Received: May 29, 2002

Dear Mr. Chang:

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 (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.

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Page 2 - Mr. Alan Chang

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Scott M. Winter, Ph.D., M.D.

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

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Page 1 of 1

021754

510(k) Number :

Device Name : Apex Medical Digital EMS TS1311, TS1312 Indications For Use:

Apex Medical Digital EMS is intended to be used in:

• 1. Relaxation of Muscle Spasm.
• 2. Prevention or retardation of disuse atrophy.
• 3. Increase local blood circulation.
• 4. Muscle re-education.
• 5. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
• 6. Maintaining or increasing range of motion.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ x (Per 21 CFR 801.109)

OR
Styk Durdis

Over-The-Counter-Use_ (Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number
K021754