(260 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is for a standard neuromuscular stimulator.
Yes
The "Intended Use / Indications for Use" section lists multiple medical conditions that the device is recommended for, such as "Relaxation of muscle spasms" and "Prevention or retardation of disuse atrophy," indicating a therapeutic purpose.
No
Explanation: The "Intended Use / Indications for Use" section lists therapeutic applications (e.g., relaxation of muscle spasms, muscle re-education) rather than diagnostic purposes (e.g., detecting, diagnosing, or monitoring a disease or condition). The device description also labels it as a "NMS device for muscle re-education," which also suggests a therapeutic function. Although the predicate device is named "Ortho Dx," this alone is not sufficient to classify the Classic Stim as a diagnostic device based on its described functions.
No
The device description explicitly states it is a "portable NMS device," which implies a hardware component for delivering electrical stimulation. The summary also mentions "output characteristics," further suggesting a physical output from a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed uses (muscle relaxation, preventing atrophy, increasing circulation, muscle re-education, preventing venous thrombosis, maintaining range of motion) are all related to physical therapy and rehabilitation, directly interacting with the patient's body.
- 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 externally to the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to stimulate muscles.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Classic Stim 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
- Maintaining or increasing range of motion
Product codes
GZJ
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 STIM™ are substantially equivalent to that of the predicate device.
Clinical Testing: Not applicable.
Conclusions from Testing: The CARE STIM™ 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)
Ortho Dx
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
KO 22417
12 Appendix F: 510 (k) Summary
APR 1 0 2003
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: | July 23, 2002 | |
| Proprietary Name: | CARE STIM™ | |
| Common Name: | Muscle Stimulator | |
| Classification Name: | Powered Muscle Stimulator
21 CFR 890.5850. | |
| Device Classification: | Class II | |
| Predicate Device: | Ortho Dx | |
| Description of Device: | A portable NMS device for muscle re-education. | |
| Intended Use: | The Classic Stim 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
• Maintaining or increasing range of motion | |
| Technological Comparison: | The CARE STIM™ 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 STIM™ is substantially equivalent to that of the
predicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristics or CARE
STIM™ are substantially equivalent to that of the predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The CARE STIM™ 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. | |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three human profiles, representing the department's focus on health and human services.
APR 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christian E. Hunt President Care Rehab and Orthopaedic 1124 Dominion Court McLean, Virginia 22102
Re: K022417
Trade Name: Care™ Stim Regulation Number: 21 CFR 890.5380 Regulation Name: Powered Exercise Equipment Regulatory Class: II Product Code: GZJ Dated: January 9, 2003 Received: January 13, 2003
Dear Mr. Hunt:
We have reviewed your Section 510(k) premarket 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, 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.
2
Page 2 -- Mr. Christian E. 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. 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,
for Mark N. Mikkelsen
elia 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
3
Indications for Use 4
510(k) Number:
Device Name: CARE STIM1M
Statement of Indication of Use:
The Classic Stim is recommended for use for the following conditions:
- Relaxation of muscle spasms 1.
- Prevention or retardation of disuse atrophy 2.
-
- Increasing local blood circulation
- Muscle re-education 4.
- Immediate post-surgical simulation of calf muscles to prevent venous thrombosis ર.
- Maintaining or increasing range of motion 6.
(PLEASE DO NOT WRITE EELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED)_
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milken
Division Sign-Off) Division of General. Restorative and Neurological Devices
510(k) Number K022417
6