(121 days)
Not Found
No
The device description focuses on basic electrical stimulation and EMG triggering with simple controls (gain and stimulation level). There is no mention of AI, ML, or any complex algorithms that would adapt or learn from data. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for stroke rehabilitation, prevention of disuse atrophy, increasing circulation, muscle re-education, and maintaining/increasing range of motion, all of which are therapeutic applications.
No
The device description indicates it is a "neuromuscular electrical stimulator device used as a training system for rehabilitation," and its intended uses are rehabilitative (e.g., muscle re-education, increasing range of motion), not for diagnosing conditions. While it picks up residual electrical muscle signals via EMG, this is used to trigger stimulation, not to provide a diagnosis.
No
The device description explicitly states it is a "portable, battery powered EMG triggered neuromuscular electrical stimulator device" and lists hardware components like patient cables, electrodes, and a belt. This indicates it is a physical hardware device, not software-only.
Based on the provided information, the Biomove 3000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Biomove 3000 Function: The Biomove 3000 is a neuromuscular electrical stimulator that works directly on the body by detecting electrical signals from muscles (EMG) and then applying electrical stimulation to those muscles. It does not analyze samples taken from the body.
- Intended Use: The intended uses listed are all related to physical rehabilitation and muscle function, not the analysis of biological samples.
- Device Description: The description clearly outlines a device that interacts with the body through electrodes and electrical signals.
Therefore, the Biomove 3000 falls under the category of a therapeutic or rehabilitation device, not an In Vitro Diagnostic device.
No
Explanation: The provided letter for the Biomove 3000 does not contain any language indicating that it is a Predetermined Change Control Plan (PCCP) authorized device. The concept of PCCP is relatively new for devices undergoing modifications but is not mentioned in this traditional clearance letter.
Intended Use / Indications for Use
The Biomove 3000 is indicated for:
- Stroke Rehabilitation by Muscle Re-education
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
The Biomove 3000 is a portable, battery powered EMG triggered neuromuscular electrical stimulator device used as a training system for rehabilitation of paralyzed muscles, mainly after stroke.
The controls of the device are simple to operate. It has only two main control knobs: one to set the gain of the EMG amplifier (sensitivity for picking up the residual electrical muscle signal) and one to set the level for the stimulation impulse to the muscles to be re-educated.
The following parts are supplied with the system: 3-lead Patient Cable, re-usable electrodes (Biotrodes) and a belt for fastening the device to the body of the user. A 5-lead Patient Cable is optional.
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
510(K) SUMMARY
Biomove 3000 System
510(k) Number K042650
- A. Applicant's Name: Curatronic Ltd. 4 Atsmon Street. Hashmonaim 73127, Israel Tel.:+972-8-9761441 Fax .: +972-8-9762020 e-mail: philipson@curatronic.com
- B. Contact Person: Arava HaCohen, RAC A. Stein - Regulatory Affairs Consulting 20 HaTa'as St. Kfar Saba 44425 Israel Tel. + 972-9-7670002 Fax. +972-9-7668534
- C. Date Prepared: September 2004
- D. Trade Name: Biomove 3000 System (also known as the Curamove 3000 System outside of the US)
- E. Classification: Name: stimulator, muscle, powered Product Code: IPF Regulation No: 890.5850 Class: II Panel: Physical Medicine
- F. Predicate Devices: The Biomove 3000 is substantially equivalent to the NeuroMove NM900 device (Dan Med, Inc.) cleared under K012885 in terms of intended use, indications for use, technological characteristics, performance and user interface.
In addition, the Biomove 3000 is substantially equivalent to the AutoMove, Model AM800 (Danmeter A/S) cleared under K032955 in terms of intended use, indications for use, technological characteristics, performance and user interface.
Both predicate devices are Class II medical devices.
A discussion of substantial equivalence is provided in Section 3 of this submission.
1
G. Device Description:
The Biomove 3000 is a portable, battery powered EMG triggered neuromuscular electrical stimulator device used as a training system for rehabilitation of paralyzed muscles, mainly after stroke.
The controls of the device are simple to operate. It has only two main control knobs: one to set the gain of the EMG amplifier (sensitivity for picking up the residual electrical muscle signal) and one to set the level for the stimulation impulse to the muscles to be re-educated.
The following parts are supplied with the system: 3-lead Patient Cable, re-usable electrodes (Biotrodes) and a belt for fastening the device to the body of the user. A 5-lead Patient Cable is optional.
H. Intended Use / Indication for Use:
The Biomove 3000 is indicated for:
1. | Stroke Rehabilitation by Muscle Re-education |
---|---|
---- | ---------------------------------------------- |
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Muscle re-education
-
- Maintaining or increasing range of motion
I. Performance Standards:
The Biomove 3000 complies with U.S. Federal Performance Standard as set forth in 21 CFR 898 for electrode lead wires and Patient Cables.
The device complies with the following recognized standards:
- IEC 60601-1(1988), including amendments #1(1991), . #2(1995)
- IEC 60601-2-10 (1987) .
The device complies with the Guidance Document for Powered Muscle Stimulator 510(k)s; Final (1999).
2
J. Substantial Equivalence:
There are no unique applications, indications, materials or specifications presented below. Evidence of equivalence has been demonstrated through:
- The Biomove 3000 intended use and indications for use were . previously cleared by FDA for the predicate devices.
- The technical characteristics of the Biomove 3000 are similar . to those of the predicate devices.
- . Safety and performance testing.
- . Comparative Testing
Therefore, the Biomove 3000 System is substantially equivalent to its predicate devices as cited above and raises no new safety and/or effectiveness issues.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the department's role within the United States government. The logo is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2005
Ms. Ahava Stein Regulatory Affairs, Consultant for Curatronic Ltd. Beit Hapa'amon (Box 124) 20 Hata'as St., 44425 Kfar Saba Israel
Re: K042650
Trade/Device Name: Biomove 3000 System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: November 28, 2004 Received: December 6, 2004
Dear Ms. Stein:
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.
4
Page 2 - Ms. Ahava Stein
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Mark A. Millhaus
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
5
INDICATIONS FOR USE
510(k) Number (if known): K042650
Device Name: Biomove 3000 System
Indications for Use:
The Biomove 3000 is indicated for:
1. | Stroke Rehabilitation by Muscle Re-education |
---|---|
2. | Prevention or retardation of disuse atrophy |
3. | Increasing local blood circulation |
4. | Muscle re-education |
5. | Maintaining or increasing range of motion |
Prescription Use_V (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)
Mark A. Mellers
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number K042650