ELFCARE DEVICE, MODELS 314A THROUGH 314G

K023231 · Mediseb , Ltd. · GZJ · Apr 4, 2003 · Neurology

Device Facts

• Record ID: K023231
• Device Name: ELFCARE DEVICE, MODELS 314A THROUGH 314G
• Applicant: Mediseb , Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Apr 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Handheld, battery-operated unit; provides combination of transcutaneous electrical nerve stimulation (TENS), powered muscle stimulation (EMS), and thermal (hot/cold) therapy. System utilizes electronically controlled thermoelectric electrode unit for heating/cooling or 4-head electrode for localized electrotherapy. Models vary by modality capability (electro-thermal vs. thermal-only vs. carbon electrode) and memory capacity (16 to 256 programs). Operated via control unit; treatment parameters/sequences pre-programmed. Used in clinical settings under medical supervision for pain management and rehabilitation. Benefits include localized pain relief, muscle spasm reduction, and improved circulation/range of motion.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility) standards was certified.

Technological Characteristics

Handheld, battery-operated unit. Features electronically controlled thermoelectric electrode unit for thermal therapy and 4-head electrode for electrotherapy. Waveforms include microcurrent, IFC, VMS Burst, Russian, and biphasic symmetrical pulses. Models 314F/G support external carbon electrodes. Compliance with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable pain, post-surgical/post-traumatic pain management, muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, range of motion maintenance/increase, prevention of post-surgical venous thrombosis, and localized thermal therapy for post-traumatic/post-surgical conditions or minor aches/pains.

Regulatory Classification

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.

Predicate Devices

• Vectra PRO 2 (K982324)
• Trio 300 (K990787)
• Thera-Temp Flexible Cold/Hot Packs (510(k) exempt)
• Artotherm Cryotherapy and Thermotherapy (K913026)
• TTU-100 (K964799)

Submission Summary (Full Text)

{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: [phone] Fax: [phone]

### 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: [phone] Fax: [phone]

#### 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<br>Flexible Cold/Hot<br>Packs | Chattanooga group Inc. | Cold Pack | 510(k) exempt |
| Artotherm<br>Cryotherapy and<br>Thermotherapy | Ormed GmbH | Thermal Therapy<br>Device | K913026 |
| TTU-100 | Danninger Medical<br>Technology Inc. | Thermal Therapy<br>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.

| <b>Cooling:</b> | In the cooling mode, the thermoelectric electrode unit produces<br>continuous and accurately controlled cold therapy to the treated<br>area. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Heating:</b> | When operated in heating mode, well-controlled heat therapy is<br>introduced to the treated area. |
| <b>Electrotherapy:</b> | The unit incorporates a 4-head electrode for localized<br>electrotherapy. Electrical and temperature calibrated modalities are<br>applied in pre-programmed sequences and combinations |

{2}------------------------------------------------

K023231

#### 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)<br>(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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{7}------------------------------------------------

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