(153 days)
No
The description focuses on basic electrical stimulation and does not mention any AI/ML components or functionalities.
Yes
The device is described as an "electronic muscle stimulator" intended for "medical purposes" that repeatedly contracts muscles by passing electrical currents to achieve therapeutic effects such as relaxing muscle spasms, preventing atrophy, increasing blood circulation, and muscle re-education.
No
The device is described as an electronic muscle stimulator with indications for therapeutic purposes like muscle relaxation, prevention of atrophy, and increasing blood circulation. It does not mention any function for diagnosing conditions.
No
The device description explicitly states it comprises an electronic stimulatory module and skin electrodes with lead wires, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an "Electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area." Its intended uses are related to muscle stimulation and rehabilitation, not the analysis of biological specimens.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological samples from the patient. The device directly interacts with the body through electrodes.
Therefore, this device falls under the category of a therapeutic or rehabilitative medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Electrically powered devices intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Indications For Use include:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
Product codes
IPF
Device Description
BE-550 is a single-channel battery operated muscle stimulation system. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires. The product is supplied with a set of single sided adhesive electrodes, an instruction manual, and a set of batteries. Power is derived from three AA cells located in a compartment protected by a removable battery cover.
The BE-550 is intended to be used as an electronic muscle stimulator.
BE-660: Is the same as the BE-550 model, but is a two-channel battery operated muscle stimulation system.
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
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
031820 1/2
Multinational
1223 Wilshire Boulevard, Suite 112 Santa Monica, California 90403 Tel/Fax (310) 393-1749
510(k) SUMMARY
| Submitter's name: | Multinational |
|---|---|
| Address: | 1223 Wilshire Blvd, Ste. 112 |
| Phone: | 310-393-1749 |
| Fax number: | 310-393-1749 |
Name of contact person:
Grace Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-
2821
grace@requlatoryspecialists.com
Date the summary was prepared:
November 4, 2003
| Name of the device: | Besmed 550 and Besmed 660 |
|---|---|
| Trade or proprietary name: | Besmed 550 and Besmed 660 |
| Common or usual name: | Electrical muscle stimulation device |
| Classification name: | Power muscle stimulator (per 21 CFR section 890.5850) |
The leqally marketed device to which we are claiming equivalence [807.92(a)(3)]:
BioStim Digital NMS, manufactured by BioMedical Life Systems. The clearance number is K010749.
Description of the device:
BE-550 is a single-channel battery operated muscle stimulation system. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires.
1
K03 820
The product is supplied with a set of single sided adhesive electrodes, an instruction manual, and a set of batteries. Power is derived from three AA cells located in a compartment protected by a removable battery cover.
The BE-550 is intended to be used as an electronic muscle stimulator.
BE-660: Is the same as the BE-550 model, but is a two-channel battery operated muscle stimulation system.
Intended use of the device:
Electrically powered devices intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Indications For Use include:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent 5. venous thrombosis
-
- Maintaining or increasing range of motion
Summary of the technological characteristics of our device compared to the predicate device:
As can be seen in both the Comparison and Standards sections, the Besmed devices and the BioStim device have similar technological characteristics and are equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2003
Multinational C/o Ms. Grace Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606
Re: K031820 Trade Name: BE-550 and BE-660
Regulation Numbers: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: II Product Codes: IPF Dated: September 8, 2003 Received: September 10, 2003
Dear Ms. Holland:
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.
3
Page 2 - Ms. Grace Holland
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,
Miriam C. Provost
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 Statement
510(k) Number (if known):
BE-550 and BE-660 Device Name:
Indications For Use:
Electrically powered devices intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Indications For Use include:
- Relaxation of muscle spasms 1.
- Prevention or retardation of disuse atrophy 2.
- Increasing local blood circulation 3.
- ধ: Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent ട്. venous thrombosis
-
- Maintaining or increasing range of motion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General, Restorative and Neurological Device
510(k) Number K031820