(108 days)
Not Found
No
The summary describes a standard electrical stimulator and does not mention any AI or ML capabilities.
Yes
The device is described as an "adjunctive therapy in the treatment of medical diseases and conditions" with specific therapeutic uses such as "relax muscle spasm," "increase local blood circulation," and "prevent venous thrombosis."
No
The device description clearly states its purpose as a non-invasive electrical stimulator for adjunctive therapy in the treatment of various medical conditions, focusing on stimulating muscles and improving circulation. It does not mention any diagnostic capabilities or the ability to identify diseases or conditions.
No
The device description explicitly states it is a "non-invasive electrical stimulator" and describes its operational modes and parameters, indicating it is a physical hardware device that delivers electrical stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Ortho Dx is described as a non-invasive electrical stimulator used for adjunctive therapy in the treatment of medical diseases and conditions. It applies electrical stimulation to the body (specifically mentioned are calf muscles) to achieve therapeutic effects like muscle relaxation, preventing atrophy, increasing blood circulation, etc.
- No Mention of Samples: There is no indication that this device analyzes any samples taken from the body. Its function is to deliver electrical stimulation to the body itself.
Therefore, the Ortho Dx falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used to, relax muscle spasm, prevent or retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.
Product codes
IPF
Device Description
The Ortho De is a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation that will operate in both modes simultaneously or independently. This system is a prescription device intended for use on patients who are undergoing rehabilitation for medical diseases and conditions on the order of a licensed practitioner.
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)
The output wave form, amplitude, pulse width, pulse rate, treatment time, NMS off time, NMS ramp up time and NMS ramp down time have been verified to the technical requirements listed in the operators manual. All measurements were taken at room temperature (72°C) with a relative humidity of 50% using a calibrated 5V power supply with a maximum capacity of 3 ampere continuous current and calibrated measurement equipment. These values are within and/or identical to the operating parameters of the predicate devices. The Ortho Dx neuromuscular stimulator uses the same power supply and proposes no additional safety considerations than the legally marketed predicate devices (NM II/III and GV II). The Line Powered Repac10 employees a UL approved power supply and is legally marketed with the predicate devices (NM II/II and GV II).
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
Ortho D. Neuromuscular Stimulator
Model 6700S
Product:
Ortho Dx Neuromuscular Stimulator, Model 6700S
AUG / 4 097
Classification:
Class II
Manufacture:
Rehabilicare Inc.
· 1811 Old Highway 8 New Brighton, MN 55112 Phone No. (612) 631-0590
Contact:
Gary L. Moore Phone No. (612) 638-0437
Predicate Products:
- GV II ™ Neuromuscular Stimulator, Model 9700/7000S, K881082 -
- Neuromuscular II (NMIII TM), Model 6800S, K840346 -
- TRI-STIM Stimulator, Muscle, Electrical Powered, Registration No. not known -
Indications For Use:
The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used to, relax muscle spasm, prevent or retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.
1
Device Description:
The Ortho De is a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation that will operate in both modes simultaneously or independently. This system is a prescription device intended for use on patients who are undergoing rehabilitation for medical diseases and conditions on the order of a licensed practitioner.
Summary of Testing:
The output wave form, amplitude, pulse width, pulse rate, treatment time, NMS off time, NMS ramp up time and NMS ramp down time have been verified to the technical requirements listed in the operators manual. All measurements were taken at room temperature (72°C) with a relative humidity of 50% using a calibrated 5V power supply with a maximum capacity of 3 ampere continuous current and calibrated measurement equipment. These values are within and/or identical to the operating parameters of the predicate devices. The Ortho Dx neuromuscular stimulator uses the same power supply and proposes no additional safety considerations than the legally marketed predicate devices (NM II/III and GV II). The Line Powered Repac10 employees a UL approved power supply and is legally marketed with the predicate devices (NM II/II and GV II).
Substantial Equivalence Summary:
The Ortho Dx ™ is a neuromuscular stimulator with a symmetric biphasic output wave form identical to the Mentor Neuromuscular II (NM III ™ ), Model 6800S, Neuromuscular Stimulator, Registration Number, K840346, and a high volt pulsed current output wave form identical to the GV II M Model 9700, High Voltage Pulsed Galvanic Stimulator, Registration Number, K881082. This type of unit, combining both types of output wave forms, is similar to a predicate device, the TRI-STIM ™ , Stimulator, Muscle, Electrical Powered, manufactured by Henley, a Division of Maxxim Medical, 104 Industrial Blvd., Sugarland, TX 77478 (registration number unknown).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary L. Moore Director of Engineering Rehabilicare Inc. 1811 Old Hiqhway 8 New Brighton, Minnesota 55112
AUG / 4 1997
Re : K971542 Ortho Dx™ Neuromuscular Stimulator Regulatory Class: II Product Code: IPF Dated: July 29, 1997 Received: August 4, 1997
Dear Mr. Moore:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Gary L. Moore
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your 510(K) prematice notification: - tho legally Finding of Bubboandar organisation a classification for your markets production permits your device to proceed to the market.
If you desire specific advice for your device on our labeling i regulation (21 CFR Part 801 and additionally 809.10 for in regaradiagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the Office or compriation as (compranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ia M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
Statement for Indication of Use:
The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used - to, relax muscle spasm, prevent or retard disuse … atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.
Sign-Off
51.JK, Number
Prescription Use
(Per 21 CFR 801.109)