(216 days)
Not Found
No
The device description focuses on basic electrical stimulation parameters (pulse rate, channels) and does not mention any adaptive, learning, or intelligent features. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described with specific 'Intended Use / Indications for Use' which align with therapeutic purposes, such as relaxing muscles, preventing muscle atrophy, and increasing blood circulation. It is also an Electrical Muscle Stimulator (EMS), which is a type of therapeutic device.
No
The device is described as a pulse generator used for muscle stimulation and relaxation, not for identifying diseases or conditions. Its intended uses are therapeutic, such as muscle re-education and preventing disuse atrophy.
No
The device description explicitly states it is a "battery operated pulse generator" and mentions "output channels" and "electrodes," indicating it is a hardware device that generates electrical impulses.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the MAXEMS devices are "battery operated pulse generators that send electrical impulses through electrodes to the body and reach the underlying muscle group." This is a physical intervention, not a test performed on a sample outside the body.
- Intended Use: The intended uses listed are all related to stimulating muscles and improving physical function, not diagnosing or detecting conditions based on biological samples.
Therefore, based on the provided information, the MAXEMS device falls under the category of a physical therapy or rehabilitation device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
-
- Relax muscles
- Prevention or retardation of disuse atrophy 2.
- Increasing local blood circulation ല്ല
- Muscle re-education ঞ্চ
- Immediate post-surgical stimulation of calf muscle to prevent venous thrombosis 5.
- Maintaining or increasing range of motion 6.
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
The MAXEMS are battery operated pulse generators that send electrical impulses through electrodes to the body and reach the underlying muscle group. The devices are provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel. Use of legally marketed, standard carbon film electrodes with a biocompatible adhesive, that are a minimum of 48mmx48mm in size and have an impedance of less than 2k ohms is recommended. The MAXEMS 1000 is an analogue unit with dual channels and a selectable pulse rate of 5, 30, and 100 Hz. The MAXEMS 2000 is a digital unit with an adjustable pulse rate from 1 to 150Hz.
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.
K072795 EMS 5.O, K020750 EV-807 Digital EMS
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
Kogizys
SECTION 5 - 510(k) Summary or 510(k) Statement
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
APPLICANT: Bio Protech
PHONE: (82) 33-747-1095
NOV 3 0 2009
FAX: (82) 33-747-1097
CONTACT PERSON: Ms. Anna Kim
OFFICIAL CORRESPONDENT: Ms. Judy Burton, Advena Ltd.
ADDRESS: 2626 Valley View Lane, Suite 4, Dallas, Texas 75234-6274
PHONE: (972) 243-5105
FAX: (972) 243-1542
DATE OF SUMMARY: November 25, 2009
TRADE NAME: MAXEMS 1000 / MAXEMS 2000
COMMON NAME: EMS
CLASSIFICATION NAME: Stimulator, Muscle, Powered
CLASSIFICATION CODE: IPF
REGULATION NO.: 890.5850
PREDICATE DEVICES: K072795 EMS 5.O / K020750 EV-807 Digital EMS
DEVICE DESCRIPTION:
The MAXEMS are battery operated pulse generators that send electrical impulses through electrodes to the body and reach the underlying muscle group. The devices are provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel. Use of legally marketed, standard carbon film electrodes with a biocompatible adhesive, that are a minimum of 48mmx48mm in size and have an impedance of less than 2k ohms is recommended. The MAXEMS 1000 is an analogue unit with dual channels and a selectable pulse rate of 5, 30, and 100 Hz. The MAXEMS 2000 is a digital unit with an adjustable pulse rate from 1 to 150Hz.
1
INTENDED USE:
-
- Relax muscles
- Prevention or retardation of disuse atrophy 2.
- Increasing local blood circulation ల్ల
- Muscle re-education ঞ্চ
- Immediate post-surgical stimulation of calf muscle to prevent venous thrombosis 5.
- Maintaining or increasing range of motion 6.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE BASED ON CLINICAL DATA: No clinical data has been included in this submission.
CONCLUSIONS DRAWN FROM NON-CLINICAL TESTS: The MAXEMS series is as safe and effective as the predicate devices cited above.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Bio Protech, Inc. % Advena, Ltd. Ms. Judy Burton Director of US Operations 2626 Valley View Lane, Suite 4 Dallas, Texas 75234-6274
NOV 3 0 2009
Re: K091248
Trade Name: MAXEMS, Models 1000 and 2000 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulation Class: Class II Product Code: IPF Dated: November 10, 2009 Received: November 18, 2009
Dear Ms. Burton:
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 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); medical device reporting of medical
3
Page 2 - Ms. Judy Burton
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 vour device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark A. Milkeron
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4 - Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name: MAXEMS 1000 / MAXEMS 2000
Indications For Use:
-
- Relax muscles
- Prevention or retardation of disuse atrophy 2.
- ന് Increasing local blood circulation
-
- Muscle re-education
- Immediate post-surgical stimulation of calf muscle to prevent venous thrombosis 5.
- Maintaining or increasing range of motion 6.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR M.MELKERSON Page 1 of 1
(Division Sign-Off)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K091248
4-1