(189 days)
Not Found
No
The description focuses on conventional electrical stimulation and thermal therapy modalities with pre-programmed sequences, and there is no mention of AI or ML.
Yes
The device provides symptomatic relief and management of pain, relaxes muscle spasms, prevents disuse atrophy, increases blood circulation, aids in muscle re-education, maintains/increases range of motion, and offers localized thermal therapy, all of which are therapeutic purposes.
No
The device is described as providing symptomatic relief, management, and treatment through electrical stimulation and hot/cold therapy. It mentions "pain relief and rehabilitation" and different modalities for muscle relaxation, circulation, and range of motion. There is no mention of identifying, confirming, or diagnosing disease or conditions.
No
The device description explicitly states it is a "lightweight hand held battery operated unit" and describes physical components like a "thermoelectric electrode unit" and a "hand-held control unit," indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for therapeutic purposes (pain relief, muscle stimulation, hot/cold therapy). IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a system that applies electrical stimulation and temperature therapy directly to the body. It does not mention analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is to deliver physical modalities to the patient.
Therefore, the ELFcare™ device, as described, falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ELFcare™ device Models 314A, 314B, 314C, 314F and 314G is a TENS device intended for the symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.
The ELFcare™ device Models 314F and 314G is a EMS device intended for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion and prevention of venous thrombosis of the calf muscles immediately after surgery.
The ELFcare™ device Models 314A, 314B, 314C, 314D, 314E is also a hot/cold therapy device intended for localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. It is also used to provide temporary relief of minor aches and pains and muscle spasms.
Product codes
GZJ, IPF, ILO
Device Description
The ELFcare™ device is a lightweight hand held battery operated unit which employs a combination application of previously well known electrical and temperature treatment modalities for pain relief and rehabilitation. The system is based on a combination of thermal transfer and conventional transcutaneous electrical stimulation therapy.
The ELFcare™ device makes use of an electronically controlled thermoelectric electrode unit that can be operated in cooling or heating modes. The thermoelectric electrode unit is controlled by the hand-held control unit.
Cooling: In the cooling mode, the thermoelectric electrode unit produces continuous and accurately controlled cold therapy to the treated area.
Heating: When operated in heating mode, well-controlled heat therapy is introduced to the treated area.
Electrotherapy: The unit incorporates a 4-head electrode for localized electrotherapy. Electrical and temperature calibrated modalities are applied in pre-programmed sequences and combinations
The ELFcare™ device combines electrical and temperature calibrated modalities by means of an electronically controlled thermoelectrode, as described above. The thermoelectrode is placed on the affected area. The thermoelectrode unit is connected to the ELFcare" Control Unit. The treatment programs and treatment parameters are controlled and operated via the ELFcare™ Control Unit.
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)
Safety Testing: Testing was carried out to assure compliance with recognized electrical safety standards. Mediseb has certified compliance with the IEC 60601-1 standard for electrical safety and compliance with the IEC 60601-1-2 standard for electromagnetic compatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982324, K990787, K913026, K964799
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
Image /page/0/Picture/1 description: The image contains a sequence of characters and numbers. The sequence starts with the letter 'k', followed by the number '0', and then the numbers '23231'. The characters and numbers are written in a handwritten style, with a slightly uneven and imperfect appearance.
Mediseb LTD
Medical Engineering
SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant:
Mediseb Ltd. 6 Galgalei Haplada Str. Herzelia, ISRAEL 46733 Tel: +972-9-9500885 Fax: +972-9-9500886
Corresponding Official:
Name: Ahava M. Stein, Consultant Address: A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Tel: +972-9-767 0002 Fax: +972-9-766 8534
Device Name:
Device trade or proprietary name: 314F and 314G Common Name: Classification Name:
ELFcare™, Models 314A, 314B, 314C, 314C, 314D, 314E, TENS / EMS/ Hot/cold pack Transcutaneous Electrical Nerve Stimulation Device, Class II, 882.5890 Powered Muscle Stimulator Device, Class II, 890.5850 Hot/Cold Pack, Class I, 890.5700
1
02321
Page 2 of 5
ediseb
Medical Engineering LTD.
Predicate Devices:
The ELFcare "14 device is substantially equivalent to a combination of the following devices. Device names', manufacturers and 510(k) numbers are designated in the following table.
| Device | Manufacturer | Type of Device | 510(k) Number |
|---|---|---|---|
| Vectra PRO 2 | Chattanooga Group Inc. | Electrotherapy Device | K982324 |
| Trio 300 | ITO CO., Ltd. | Electrotherapy Device | K990787 |
| Thera-Temp | |||
| Flexible Cold/Hot | |||
| Packs | Chattanooga group Inc. | Cold Pack | 510(k) exempt |
| Artotherm | |||
| Cryotherapy and | |||
| Thermotherapy | Ormed GmbH | Thermal Therapy | |
| Device | K913026 | ||
| TTU-100 | Danninger Medical | ||
| Technology Inc. | Thermal Therapy | ||
| Device | K964799 |
Description of the Device:
The ELFcare™ device is a lightweight hand held battery operated unit which employs a combination application of previously well known electrical and temperature treatment modalities for pain relief and rehabilitation. The system is based on a combination of thermal transfer and conventional transcutaneous electrical stimulation therapy.
The ELFcare™ device makes use of an electronically controlled thermoelectric electrode unit that can be operated in cooling or heating modes. The thermoelectric electrode unit is controlled by the hand-held control unit.
| Cooling: | In the cooling mode, the thermoelectric electrode unit produces
continuous and accurately controlled cold therapy to the treated
area. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Heating: | When operated in heating mode, well-controlled heat therapy is
introduced to the treated area. |
| Electrotherapy: | The unit incorporates a 4-head electrode for localized
electrotherapy. Electrical and temperature calibrated modalities are
applied in pre-programmed sequences and combinations |
2
Page 4 of 5
ediseb LTD.
Medical Engineering
The ELFcare™ device combines electrical and temperature calibrated modalities by means of an electronically controlled thermoelectrode, as described above. The thermoelectrode is placed on the affected area. The thermoelectrode unit is connected to the ELFcare" Control Unit. The treatment programs and treatment parameters are controlled and operated via the ELFcare™ Control Unit.
The following table presents the different models of the ELFcare™ device that are available:
| Features / Model | 314A | 314B | 314C | 314D | 314E | 314F | 314G |
|---|---|---|---|---|---|---|---|
| Electrode Type | |||||||
| Electro-Thermal Electrode | ● | ● | ● | ||||
| Thermal (Hot/Cold) | ● | ● | |||||
| Carbon Electrode (Regular) | |||||||
| (not supplied w/ device) | ● | ● | |||||
| Electrotherapy | |||||||
| Waveforms | |||||||
| Microcurrent | ● | ● | ● | ● | ● | ||
| IFC (Premodulated Interferential) | ● | ● | ● | ● | ● | ||
| VMS Burst | ● | ● | ● | ● | ● | ||
| Russian | ● | ● | ● | ● | ● | ||
| Biphasic Symmetrical Pulses | ● | ● | ● | ● | ● | ||
| Preset Procedures | |||||||
| Capability | |||||||
| 16 Programs | |||||||
| 32 Programs | ● | ||||||
| 64 Programs | ● | ● | |||||
| 128 Programs | |||||||
| 256 Programs | ● | ● |
General differences between the models:
- · The ELFcare™ Models 314A, 314B and 314C use the thermoelectrod. The models varied just by the device memory capabilities as describe in the above table.
- · The ELFcare™ Models 314D, 314E are limited to provide only the hot and cold features without electrotherapy capabilities.
- The ELFcare™ Models 314F, 314G are provided without the thermoelectrod. The user can connect standard carbon electrodes using the supplied adaptors.
3
Image /page/3/Picture/1 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the number '0', then '2', '3', '2', '3', and ends with '1'. The characters are written in a simple, slightly irregular style, typical of handwriting. The contrast is high, with dark characters against a light background, making them easily readable.
ediseb
Medical Engineering
Intended Use:
The ELFcare™ device Models 314A, 314B, 314C, 314F and 314G is a TENS device intended for the symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.
The ELFcare™ device Models 314F and 314G is a EMS device intended for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion and prevention of venous thrombosis of the calf muscles immediately after surgery.
The ELFcare™ device Models 314A, 314B, 314C, 314D, 314E is also a hot/cold therapy device intended for localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. It is also used to provide temporary relief of minor aches and pains and muscle spasms.
4
Page 5 of 5
Performance data:
Safety Testing:
Testing was carried out to assure compliance with recognized electrical safety standards. Mediseb has certified compliance with the IEC 60601-1 standard for electrical safety and compliance with the IEC 60601-1-2 standard for electromagnetic compatibility.
Technological Characteristics Compared to Predicate Device
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the ELFcare™ device are substantially equivalent to the predicate devices cited above.
5
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR o 4 2003
Mediseb Ltd. c/o Ms. Ahava M. Stein Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba, ISRAEL
Re: K023231
Trade/Device Name: The ELFcare™. Models 314A, 314B, 314C, 314F and 314G The ELFcare™, Models 314F and 314G The ELFcare™, Models 314A, 314B, 314C, 314C, 314D and 314E Regulation Numbers: 21 CFR 882.5890, 21 CFR 890.5850, 21 CFR 890.5720 Regulation Names: Transcutaneous electrical nerve stimulator for pain relief Powered muscle stimulator Water circulating hot or cold pack Regulatory Class: Class II Product Codes: GZJ, IPF, ILO Dated: December 23, 2002 Received: January 6, 2003
Dear Ms. Stein:
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. Iisting 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.
6
Page 2 - Ms. Ahava M. Stein
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.
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.
Sincerely yours,
Mark n Milhem
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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Image /page/7/Picture/1 description: The image shows the logo for Mediseb LTD. The logo is in black and white and features the company name in a stylized font. Below the company name, the words "Medical Engineering" are written in a smaller font. The logo is simple and professional, and it conveys the company's focus on medical engineering.
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K023231 |
|---|---|
| Device Name: | ELFcare™, Models: 314A, 314B, 314C, 314D, 314E, 314F and 314G |
| Indications for use: | For Microcurrent and IFC (Premodulated Interferential) electrical stimulation using models 314A, 314B, 314C, 314F and 314G: |
| - Symptomatic relief and management of chronic intractable pain | |
| - Adjunctive treatment in the management of post-surgical and post-traumatic pain. | |
| For VMS Burst, Russian and Biphasic Symmetrical Pulses electrical stimulation using models 314F and 314G: | |
| - Relaxation of muscle spasms | |
| - Prevention or retardation of disuse atrophy | |
| - Increasing local blood circulation | |
| - Muscle re-education | |
| - Maintaining or increasing range of motion | |
| - Prevention of venous thrombosis of the calf muscles immediately after surgery | |
| For Hot/Cold therapy using models: 314A, 314B, 314C, 314D, 314E: |
- Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
- Temporary relief of minor aches and pains and muscle spasms -
(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 C.F.R. 801/109)
OR Over-The-Counter Use
(Optional Format 1-2-96
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. K023231