(29 days)
No
The document describes modifications to an electrical muscle stimulator focused on output current, programs, and case, with no mention of AI or ML technologies.
Yes
The device is described as an Electrical Muscle Stimulator intended for medical purposes, with indications for use such as relaxing muscle spasms and increasing local blood circulation, which are therapeutic functions.
No
Explanation: The document describes the device as an Electrical Muscle Stimulator intended for therapeutic purposes like relaxing muscle spasms, increasing local blood circulation, preventing venous thrombosis, muscle re-education, maintaining or increasing range of motion, and preventing disuse atrophy. These are all treatment functions, not diagnostic ones.
No
The device description explicitly states it is an "Electrical Muscle Stimulator" and describes modifications to a "Digital Electrical Stimulator," indicating it is a hardware device that delivers electrical currents through electrodes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies electrical stimulation to the body for therapeutic purposes (muscle relaxation, blood circulation, preventing thrombosis, muscle re-education, range of motion, preventing atrophy). This is a direct interaction with the patient's body for treatment.
- IVD Definition: In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
- Device Description: The description focuses on the electrical stimulation capabilities and physical modifications, not on any analytical or diagnostic functions.
Therefore, the EV-807P Electrical Muscle Stimulator falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
EV-807P Electrical Muscle Stimulator 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
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 including linearly increase of output current, more programs for the physical therapist to create different parameters, more options of output type between 2 channels and device case. The modifications of the predicate device make the stimulation even more comfortable and effective.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected body area, calf muscles.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical purposes, physical therapist.
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)
Reference Device(s)
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
OCT 2 9 2003
As Required by 21 section 807.92 ( c )
510(k) Summarv
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)
- (770) 777- 4146 3-Phone:
(678) 623- 3765 4-Fax:
Mr Robert Tu (General Manager) 5-Contact Person:
- 6-Date summary prepared: September 25th, 2003
- 7 Official Correspondent: Mansour Consulting LLC
- 8- Address: 1308 Morningside 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: Neuromuscular Electrical 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 including linearly increase of output current, more programs for the physical therapist to create different parameters, more options of output type between 2 channels and device case. The modifications of the predicate device make the stimulation even more comfortable and effective.
The intended use of the modified devices is the same as for the predicate device. In addition, the scientific technology, manufacturing methods, 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)
EV-807P Electrical Muscle Stimulator 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. ﻤ
- 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 -
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)
1
19-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that EV-807P is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency detailed chart path is attached.
| FDA file reference number | 510k # of predicate : K020750 |
|---|---|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Nor Applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Not Applicable |
| Anatomical sites | Not Applicable |
| Human factors | Not Applicable |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other | Identical |
| devices | |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| Thermal safety | Identical. |
| Radiation safety | Not Applicable. |
Detailed technical comparison is included within main submission
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines beneath them.
Public Health Service
OCT 2 9 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: K033140
Trade/Device Name: Neuromuscular Electrical Stimulator, EV-807P (Electrical Muscle Stimulator) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: September 25, 2003 Received: September 30, 2003
Dear Mr. Mansour:
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 (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.
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 yours.
sincerely yours,
Mark N Millman
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
Page 1 of
510(k) Number (if known): 1633191
Device Name: Neuromuscular Electrical Stimulator, EV-807P (Electrical Muscle Stimulator)
Indications for Use:
EV-807P Electrical Muscle Stimulator 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 -
Marti A. Milkman
Division Sign-Off) Division of General, Restorative and Neurological Devices
(033140 510(k) Number -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurence of CDRH, Office of Device Evaulation (ODE)
(Optional Format 3-10-98)