(57 days)
Not Found
No
The device description and intended use focus on basic electrical stimulation parameters (pulse rate, channels) and do not mention any adaptive, learning, or intelligent features. There is no mention of AI, ML, or related terms in the provided text.
Yes
The device is intended for medical purposes such as relaxing muscle spasms, increasing local blood circulation, preventing venous thrombosis, muscle re-education, maintaining or increasing range of motion, and preventing or retarding disuse atrophy. These are all therapeutic applications.
No
This device is an Electrical Muscle Stimulator (EMS) used for therapeutic purposes such as relaxing muscle spasms, increasing local blood circulation, preventing venous thrombosis, muscle re-education, maintaining or increasing range of motion, and preventing or retarding disuse atrophy. It generates electrical impulses to contract muscles, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is a "battery operated pulse generator" and an "analogue unit," indicating it is a hardware device that generates electrical impulses.
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, circulation, re-education, etc.). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a pulse generator and electrodes that deliver electrical impulses to the body. This aligns with the function of a therapeutic electrical muscle stimulator.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are designed to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a therapeutic medical device, specifically an electrical muscle stimulator, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Electrical Muscle Stimulator Series (Model Numbers EMS 5.0, EMS 5.1) 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
EMS is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reaches the underlying or muscle group. Both EMS 5.0 and EMS 5.1 are analogue units with dual channel. EMS 5.0 has a selectable pulse rate of 5, 30 and 100 Hz, while EMS 5.1 has an adjustable pulse rate of 2 to 150 Hz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
calf muscles
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)
Reference Device(s)
Not Found
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
510(k) Summary As Required by 21 section 807.92 ( c )
1-Submitter Name: Koalaty Products, Inc 5015 N. Clark Ave. 2-Address: Tampa, FL 33614 813 871 5901 3-Phone: 813 871 5904 4-Fax: 5-Contact Person: Mr Jeff Lenoir (President) 6-Date summary prepared: September 7th, 2007 7 - Official Correspondent: Mansour Consulting LLC 8- Address: 845 Aronson Lake Court. Roswell, GA 30075 USA 9- Phone: 678-908-8180 10- Fax: 678-623-3765 11- Contact Person: Jav Mansour, President 12-Device Trade or Proprietary Name: (a) EMS (Model EMS 5.0) (b) EMS (Model EMS 5.1) 13-Device Common or usual name: EMS 14-Device Classification Name: Stimulator, muscle, powered 15-Substantial Equivalency is claimed against the following device: Models N605 and N607 of 510k #K033544
16-Description of the Device:
EMS is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reaches the underlying or muscle group. Both EMS 5.0 and EMS 5.1 are analogue units with dual channel. EMS 5.0 has a selectable pulse rate of 5, 30 and 100 Hz, while EMS 5.1 has an adjustable pulse rate of 2 to 150 Hz.
17-Intended use of the device: (refer to FDA form attached)
Electrical Muscle Stimulator Series (Model Numbers EMS 5.0, EMS 5.1) 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
18-Safety and Effectiveness of the device:
This series is safe and effective as the predicate devices cited above.
NOV 2 7 2007
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping curved lines forming its body and wings. The eagle faces left. Surrounding the eagle in a circular arrangement are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
NOV 2 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Koalaty Products, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo Minnesota 55313
K072795 Re: Roy2733 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: November 13, 2007 Received: November 15, 2007
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association in the encreations of 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.
2
Page 2 - Mr. Mark Job
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to begin mailieding of substantial equivalence of your device to a legally premarket notification. The PDF mianing of cation 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 If you desire specific at rior is and Radiological Health's (CDRH's) Office of Compliance at (240) 276-3464. Also, please note the regulation entitled, "Misbranding by reference to (240) 270 510 1. This, process now more of 807.97). For questions regarding postmarket surveillance, premarket nother (215-11) Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems (Mcdical Dovice Reporting (112-17)) fromation on your responsibilities under the at (210) 210 3 10 11 1 2001 13 2001 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 at its toll free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K072795
Device Name: Electrical Muscle Stimulator Models EMS 5.0 and EMS 5.1
Indications For Use:
Electrical Muscle Stimulator Series (Model Numbers EMS 5.0, EMS 5.1) 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 .
Prescription Use X (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 CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K072755 |
|---|---|
| --------------- | --------- |
Pagel of