(30 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a change from a digital to an analog version of the device, focusing on basic electrical stimulation parameters.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use for medical purposes" and lists several therapeutic applications such as "relaxing muscle spasms," "increasing local blood circulation," and "muscle re-education."
No
Explanation: The "Intended Use / Indications for Use" section describes the device as an electrical muscle stimulator intended to contract muscles for therapeutic purposes (e.g., relaxing muscle spasms, increasing local circulation, muscle re-education). It does not mention any function for diagnosing conditions.
No
The device description explicitly states it is a modification to an "Electrically Powered Muscle Stimulator" and describes changes to physical components like "buttons to adjust parameters and shape unit," indicating it is a hardware device with electrical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies electrical currents to the body to stimulate muscles for therapeutic purposes (relaxing spasms, increasing circulation, preventing thrombosis, etc.). This is a direct interaction with the patient's body for treatment.
- Device Description: The description reinforces that it's an electrical muscle stimulator that contacts the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing information about a disease or condition based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
ELECTRICAL MUSCLE STIMULATOR SERIES IS AN ELECTRICALLY POWERED MUSCLE STIMULATOR INTENDED FOR USE FOR MEDICAL PURPOSES TO REPEATEDLY CONTRACT MUSCLES BY PASSING ELECTRICAL CURRENTS THROUGH ELECTRODES CONTACTING THE AFFECTED BODY AREA. IN PARTICULAR, THIS DEVICE IS INDICATED FOR USE for:
- RELAXING MUSCLE SPASMS
- INCREASING LOCAL BLOOD CIRCULATION
- IMMEDIATE POST-SURGICAL STIMULATION OF CALF MUSCLES TO PREVENT VENOUS THROMBOSIS
- MUSCLE RE-EDUCATION
- MAINTAINING OR INCREASING RANGE OF MOTION
- PREVENTING OR RETARDING DISUSE ATROPHY
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
The Special 510(k) premarket notification describes a modification to Everyway's currently legally marketed EV-807 Digital Electrical Stimulator. The proposed modifications include technical specifications (Output amplitude, range of pulse width, pulse rate, ramp time), buttons to adjust parameters and shape unit. Basically the change is from digital version to analogue version of EMS. The specifications of units are modified according to the requirements of customers while are still very similar to the predicated unit. The intended use of the modified devices is the same as for the predicate device. In addition, the scientific technology, manufacturing methods, and operating principles for the changed devices are equivalent to those of the predicate device.
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.
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
§ 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
DEC 1 0 2003
510(k) Summary As Required by 21 section 807.92 ( c )
Everyway Medical Instruments Co., Ltd 1-Submitter Name:
3FL.. No.5. LANE 155, Sec. 3, Peishen Rd 2-Address:
Shen Keng Hsiang. Taipei Hsien. Taiwan (ROC)
(886) 2 2662 0038 3-Phone:
(886) 2 2664 5566 4-Fax:
5-Contact Person: Mr Robert Tu (General Manager)
6-Date summary prepared: November 3rd, 2003
7 - Official Correspondent: Mansour Consulting LLC
8- Address: 1308 Momingside Park Dr. Alpharetta, GA 30022 USA
9- Phone: 770-777-4146
10- Fax: 678-623-3765
11- Contact Person: Jay Mansour, President
12-Device Trade or Proprietary Name: Electrical Muscle Stimulator
13-Device Common or usual name: EMS
14-Device Classification Name: Stimulator, muscle, powered
15-Substantial Equivalency is claimed against the following device:
- Digital EMS, model EV-807 from Everyway Medical Instruments Co., Ltd. . 510k# K020750
16-Description of the Device:
The Special 510(k) premarket notification describes a modification to Everyway's currently legally marketed EV-807 Digital Electrical Stimulator. The proposed modifications include technical specifications (Output amplitude, range of pulse width, pulse rate, ramp time), buttons to adjust parameters and shape unit. Basically the change is from digital version to analogue version of EMS. The specifications of units are modified according to the requirements of customers while are still very similar to the predicated unit.
The intended use of the modified devices is the same as for the predicate device. In addition, the scientific technology, manufacturing methods, and operating principles for the changed devices are equivalent to those of the predicate device.
17-Intended use of the device: (refer to FDA form attached)
Electrical Muscle Stimulator Series (Model Numbers N605, N607) is an electrically powered muscle stimulator intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for:
- Relaxing muscle spasms -
- Increasing local blood circulation. -
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. -
- Muscle re-education. -
- Maintaining or increasing range of motion ー
- Preventing or retarding disuse atrophy -
1
18-Safety and Effectiveness of the device:
This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SUBSTANTIALLY EQUIVALENT to the predicate device. Refer to the explanations/details within the main submission.
| FDA file reference number | 510k # K020750 |
|---|---|
| TECHNOLOGICAL | |
| CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Not Applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Not Applicable |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and | |
| other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| Thermal safety | Identical |
| Radiation safety | Not Applicable |
Refer to the submission for more details.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
DEC 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Everyway Medical Instruments Co., Ltd. C/o Mr. Jay Mansour, MSQA, BE, LA, RAC President Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, Georgia 30022
Re: K033544
Trade/Devicc Name: Electrical Muscle Stimulator, Models N605 and N607 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: November 3, 2003 Received: November 10, 2003
Dear Mr. Mansour:
We have reviewed your Scction 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.
3
Page 2 - Mr. Jay Mansour, MSQA, BE, LA, RAC
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. 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/dsma/dsmamain.html
Sincerely vours.
Mark McMullan
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
4
Indications for Use
510(k) Number (if known): K C 335544
Device Name: ELECTRICAL MUSCLE STIMULATIR - HODELS N603KN607
Indications For Use:
ELECTRICAL MUSCLE STIMULATOR SERIES IS AN ELECTRICALLY
POWERED MUSCLE STIMULATOR INTENDED FOR USE FOR MEDICAL
PURPOSES TO REPEATEDLY CONTRACT MUSCLES BY PASSING ELECTRICAL
CURRENTS THROUGH ELECTRODES CONTACTING THE AFFECTED BODY ARGA.
IN PORTICULAR, THIS DEVICE IS INDICATED FOR USE for 2
- RELAXING MUSCLE SPASHS
- INCREASING LOCAL BLOGO CIRCULATIon
- INCESSION BEST SURGICAL STIMULATION of CALF MUSELES TO PECIENT THROMBOSIS
- MUSCLE RE-EDUCATION
- MAINTAINING OR INCREASING RANGE of MOTIO
- PREVENTING OR RETARDING DISUSE
Over-The-Counter Use AND/OR Prescription Use (Part 21 CFR 801 Subpart D) (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)
Mark N. Millican
Cock Restorative carological Devices
(k) Number K033544
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