(280 days)
Not Found
No
The document describes a standard neuromuscular stimulator (NMS) device with biofeedback and muscle re-education capabilities. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The comparison is made to a predicate device from 1997, which predates widespread medical device AI/ML integration.
Yes
The device is described as an NMS (Neuromuscular Stimulator) device intended for therapy such as muscle re-education, relaxation of muscle spasms, and increasing range of motion, which are therapeutic applications.
No
The provided text describes the device's intended use for therapeutic applications like muscle re-education, relaxation, and prevention of disuse atrophy, but it does not mention any diagnostic capabilities or the ability to identify or characterize diseases or conditions.
No
The device description explicitly states it is a "portable NMS device," which implies hardware components are involved in delivering the electrical stimulation. The intended use also describes conditions treated by electrical stimulation, further supporting the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The stated uses (biofeedback, relaxation training, muscle re-education, muscle spasm relaxation, disuse atrophy prevention, blood circulation increase, post-surgical stimulation, range of motion maintenance, stroke rehabilitation) all relate to treating or managing conditions within the body through electrical stimulation and biofeedback.
- Device Description: It's described as a "portable NMS device for muscle re-education." NMS stands for Neuromuscular Stimulation, which is a therapeutic technique applied to the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, tissue, etc.) to diagnose or monitor a condition. IVDs are specifically designed for this type of in vitro (outside the body) analysis.
Therefore, this device falls under the category of a therapeutic or rehabilitation device, not an IVD.
N/A
Intended Use / Indications for Use
The Care ETS is recommended for use for the following conditions:
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical simulation of calf muscles to prevent venous thrombosis
• Stroke Rehabilitation , using muscle re-education techniques
• Maintaining or increasing range of motion
Statement of Indication of Use (in EMG Mode):
- Biofcodback 1.
- Relaxation Training 2.
-
- Muscle Rc-Education
Statement of Ladication of Use (in NMS Mode):
The Care ETS is recommended for use for the following conditions:
- Relaxation of muscle spasms 】.
- Prevention or retardation of disuse atrophy 2
- ಗ Increasing local blood circulation
- Muscle recordication র্ব
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis . ਨ.
- Maintaining or increasing range of motion. ర్
-
- Stroke Rehabilitation, using muscle re-education techniques
Product codes
IPF, HCC
Device Description
A portable NMS device for muscle re-education.
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)
Nonclinical Testing: Bench testing demonstrated that the output characteristics or CARE ETS™ are substantially equivalent to that of the predicate device.
Clinical Testing: Not applicable.
Conclusions from Testing: The CARE ETS™ is substantially equivalent in electrical output to the predicate device and any differences between the devices do not pose new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Automove AM800 (K972997)
Reference Device(s)
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
Appendix J: 510(k) Summary
510(k) Summary
| Submitter's Information: | Christian E. Hunt
Care Rehab®
1124 Dominion Ct
McLean, VA 22102 | Phone: 1-703-448-9644
FAX: 1-703-356-2182. |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Date of preparation: | March 20, 2003 | |
| Proprietary Name: | CARE ETS™ | |
| Common Name: | Neuromuscular Stimulator ( EMG Triggered) | |
| Classification Name: | Powered Muscle Stimulator
21 CFR 890.5850. | |
| Panel Code: | 89 | |
| Product Code: | IPF | |
| Device Classification: | Class II | |
| Predicate Device: | Automove AM800 (K972997) | |
| Description of Device: | A portable NMS device for muscle re-education. | |
| Intended Use: | The Care ETS is recommended for use for the following conditions:
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical simulation of calf muscles to prevent venous
thrombosis
• Stroke Rehabilitation , using muscle re-education techniques
• Maintaining or increasing range of motion | |
| Technological Comparison: | The CARE ETS™ has technological characteristics that are
substantially equivalent to those of the predicate device, as determined
by bench testing. | |
| Labeling Comparison: | The labeling of the CARE ETS™ is substantially equivalent to that of the
predicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristics or CARE
ETS™ are substantially equivalent to that of the predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The CARE ETS™ is substantially equivalent in electrical output to the
predicate device and any differences between the devices do not pose new
questions of safety and effectiveness. | |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2003
Mr. Christian Hunt President Care Rehab and Orthopedic Products, Inc. P.O. Box 580 McLean, Virginia 22101
Re: K023036
Trade/Device Name: Regulation Number: 21 CFR 890.5850, 21 CFR 882.5050 Regulation Name: Powered muscle stimulator, Biofeedback device Regulatory Class: II Product Code: IPF, HCC Dated: March 21, 2003 Received: March 21, 2003
Dear Mr. Hunt:
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.
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Page 2 - Mr. Christian Hunt
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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 vours.
Mark H. Millken
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
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Indications for Use বা
510(k) Number:
Device Name: CARE ETS™
Statement of Indication of Use (in EMG Mode):
- Biofcodback 1.
- Relaxation Training 2.
-
- Muscle Rc-Education
Statement of Ladication of Use (in NMS Mode):
The Care ETS is recommended for use for the following conditions:
- Relaxation of muscle spasms 】.
- Prevention or retardation of disuse atrophy 2
- ಗ Increasing local blood circulation
- Muscle recordication র্ব
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis . ਨ.
- Maintaining or increasing range of motion. ర్
-
- Stroke Rehabilitation, using muscle re-education techniques
PLASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Milliken
(Divisio Jigi-Off) Division of General. Restorative and Neurological Devices
510" number K02309
A 20:51 E 0005 81 MUL
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