(161 days)
No
The device description and performance studies focus on standard electrical stimulation technology and safety compliance, with no mention of AI or ML.
Yes
The device is described as a "neuromuscular electronic stimulators indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions," with stated intended uses like "Relaxation of muscle spasms" and "Prevention or retardation of disuse atrophy," all of which point to a therapeutic function.
No
The device is described as a "neuromuscular electronic stimulator" and is used for therapeutic purposes like "relaxation of muscle spasms" and "muscle re-education," not for diagnosing medical conditions.
No
The device description explicitly states it is a "battery powered handheld Neuro-Muscular Electrical Stimulation (NMES) device," indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to neuromuscular electrical stimulation for therapeutic purposes (muscle relaxation, atrophy prevention, blood circulation, muscle re-education, thrombosis prevention, range of motion). These are treatments applied to the body, not tests performed on samples taken from the body.
- Device Description: The description clearly states it's a Neuro-Muscular Electrical Stimulation (NMES) device. This type of device delivers electrical impulses to muscles and nerves.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used 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 CEFAR REHAB 2 and CEFAR REHAB 2 PRO are symmetrical biphasic neuromuscular electronic stimulators indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. Intended uses 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
The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are battery powered handheld Neuro-Muscular Electrical Stimulation (NMES) devices only to be used under medical supervision for adjunctive therapy of medical diseases and conditions. The devices operate with two channels and 22 preset stimulation programs. On the CEFAR REHAB 2 PRO the user also can set parameters to create user defined stimulation programs.
Program information and amplitude is displayed on a LCD. The user can set the amplitude in the range 0-100 mA for all programs.
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
under medical supervision
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)
An extensive collection of tests has been conducted and successfully completed, including system validation in-house and external testing to show compliance with IEC EN 60 601-1-2 regarding EMC, IEC EN 60601-1 regarding general safety for medical equipment.
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).
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APPENDIX I. 510(K) SUMMARY
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the CEFAR Medical AB summary for the CEFAR REHAB 2 and REHAB 2 PRO:
| SUBMITTER'S NAME: | CEFAR Medical AB |
|---|---|
| ADDRESS: | Scheelevagen 19A |
| SE-223 70 Lund | |
| Sweden | |
| CONTACT PERSON: | Constance Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-571-2437 |
| DATE OF SUBMISSION: | February 4, 2003 |
1. Identification of device
Proprietary Name: CEFAR REHAB 2 and REHAB 2 PRO Common Name: Powered muscle stimulator Classification Status: Class II per regulations 890.5850 Product Codes: IPF
2. Equivalent devices
CEFAR Medical AB believes the CEFAR REHAB 2 and REHAB 2 PRO is substantially equivalent to:
Powered Muscle Stimulator Ortho DX Rehabilicare K971542
3. Description of the Device
The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are battery powered handheld Neuro-Muscular Electrical Stimulation (NMES) devices only to be used under medical supervision for adjunctive therapy of medical diseases and conditions. The devices operate with two channels and 22 preset stimulation programs. On the CEFAR REHAB 2 PRO the user also can set parameters to create user defined stimulation programs.
Program information and amplitude is displayed on a LCD. The user can set the amplitude in the range 0-100 mA for all programs.
4. Intended use
The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are symmetrical biphasic neuromuscular electronic stimulators indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. Intended uses 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
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5. Comparison to predicate device.
Comparison table
| Characteristic | Ortho DX
(Predicate device) | CEFAR REHAB 2 and
CEFAR REHAB 2 PRO |
|------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indications for use statement | Identical | See Section 1 B Indications for
Use Statement |
| Prescription device | Yes | Yes |
| Number of channels | 2 | 2 |
| Output | 0-100 mA | 0-100 mA |
| Wave form | Symmetrical biphasic rectangle
with zero net DC | Symmetrical biphasic
rectangle with zero net DC |
| Pulse width | 0-300 $ \mu $ s | 50-300 $ \mu $ s |
| Maximum charge per
pulse | 30 $ \mu $ C | 30 $ \mu $ C |
| Pulse rate | 33.3 Hz, fixed | 2-120 Hz, fixed in each
preset program |
| Transcutaneous current
delivery | Yes, through electrodes placed
on patients body | Yes, through electrodes
placed on patients body |
| User control of output | Yes, knobs | Yes, pushbuttons |
| Power supply | Yes, battery operated 4xAA
batteries (rechargeable or
alkaline) | Yes, battery operated 2xAA
batteries (rechargeable or
alkaline) |
Discussion of functional and safety testing. 6.
An extensive collection of tests has been conducted and successfully completed, including system validation in-house and external testing to show compliance with IEC EN 60 601-1-2 regarding EMC, IEC EN 60601-1 regarding general safety for medical equipment.
Notified body SEMKO AB, with ID 0413, has performed the external testing.
7. Conclusion
Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of CEFAR Medical AB that the CEFAR REHAB 2 and CEFAR REHAB 2 PRO are substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the department's name around the perimeter. Inside the circle is a stylized image of three abstract shapes, possibly representing human figures or elements of health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2003
CEFAR Medical AB c/o Ms. Constance G. Bundy C.G. Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, MN 55432
Re: K030403
Trade/Device Name: CEFAR REHAB 2 and CEFAR REHAB 2 PRO Regulation Numbers: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: II Product Codes: IPF Dated: May 7, 2003 Received: May 12, 2003
Dear Ms. Bundy:
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 - Ms. Constance G. Bundy
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,
Mark A. Millerson
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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Page 1 of 1
1.B. Indications for Use KO30403 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Device Name: CEFAR REHAB 2 and CEFAR REHAB 2 PRO
Indications for Use:
The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are symmetrical biphasic neuromuscular electronic stimulators indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. Intended uses 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
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use
for Mark N Mulkern
(Division Si
ision of Genera . Restorative dological f
510(k) Number K030403
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