(142 days)
Not Found
CES Ultra, ELECTRONIC PAIN RELIEVERS
No
The device description details standard electrical stimulation therapies (CES and TENS) with user-selectable parameters (mode, pulse width, pulse rate, treatment time). There is no mention of AI, ML, or any adaptive or learning algorithms.
Yes
The device is indicated for the treatment of various medical conditions, including insomnia, depression, anxiety, and pain, which are therapeutic applications.
No
The device is a stimulator (Cranial Electrical Nerve Stimulator, Transcutaneous Electrical Nerve Stimulation) used for therapy (treatment of insomnia, depression, anxiety, and pain relief), not for diagnosing conditions.
No
The device description explicitly states it is a "portable Cranial Electrical Nerve Stimulator" and describes hardware components like a slide switch, analog pots, and battery operation, indicating it is a physical device, not software-only.
Based on the provided information, the FM 10/C device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for treating conditions like insomnia, depression, anxiety, and pain. These are all conditions treated in vivo (within the living body) through electrical stimulation.
- Device Description: The device is described as a Cranial Electrical Nerve Stimulator and combines CES and TENS therapies. These are forms of electrical stimulation applied to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples taken from the body to diagnose or monitor conditions. The FM 10/C is a therapeutic device that applies electrical stimulation directly to the body.
N/A
Intended Use / Indications for Use
FM 10/C is indicated to be used for:
- CES for the treatment of insomnia, depression, or anxiety. .
- TNS for Symptomatic relief and management of chronic intractable pain and/or . as an adjunctive treatment in the management of post-traumatic and postsurgical acute pain.
Product codes
JXK, GZJ
Device Description
FM 10/C is portable Cranial Electrical Nerve Stimulator. FM 10/C combines uniquely two proven therapies CES for the treatment of insomnia, depression, or anxiety and TENS for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain. Thus FM 10/C offers a partnership between Transcutaneous Electrical Nerve Stimulation (TENS) and Cranial Electrotherapy Stimulation (CES).
FM 10/C has three modes viz. (i) TENS Burst (ii) TENS Conventional and (iii) CES mode. It provides easy mode selection through slide switch and user can select any one of the available modes through it. TENS and CES modes will not operate simultaneously so, if CES Leads are inserted then TENS modes are automatically blocked for the user and vice versa.
TENS mode is programmable and user will have the option to select pulse width and pulse rate using analog pots. In addition treatment time is also selectable using a slide switch options available are 30 minutes or continuous treatment time. FM 10/c is only battery operated, with low battery indication.
FM 10/C comes complete with all the necessary components of same quality and standards as being provided with Predicate Device CES Ultra and ELECTRONIC PAIN RELIEVERS to perform Electrical Stimulation. Below is a list of items that are included:
- FM 10/C Unit - 01 no.
- Round Electrode Lead Wire (2 pole, 116.5 cm, 4mm Diameter Plug) - 02 nos.
- Ear Clip Electrodes (Surface Area 7.9 mm max) With Round Lead wire (2 Pole, 116.5 cm, 5mm Diameter Plug) - 01 nos.
- Electrodes (Round 2") - 04 nos.
- Electrode gel (250 ml) - 01 tube
- Manual - 01 no.
The electrodes are legally marketed in U.S., manufactured by:
WANDY RUBBER INDUSTRIAL CO, LTD.
NO.24, ALLEY 37, LANE 392, FU TEH 1ST RD.,
HSI-CHIH 221, TAIPEI, TAIWAN
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5800 Cranial electrotherapy stimulator.
(a)
Identification. A cranial electrotherapy stimulator is a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions.(b)
Classification. (1) Class II (special controls) when intended to treat insomnia and/or anxiety. The special controls for this device are:(i) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device to treat insomnia and/or anxiety.
(ii) Components of the device that come into human contact must be demonstrated to be biocompatible.
(iii) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC) in its intended use environment.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge, and energy, must be fully characterized and verified.
(vi) The labeling for the device must include the following:
(A) The intended use population and the intended use environment;
(B) A warning that patients should be monitored by their physician for signs of worsening;
(C) A warning that instructs patients on how to mitigate the risk of headaches, and what to do should a headache occur;
(D) A warning that instructs patients on how to mitigate the risk of dizziness, and what to do should dizziness occur;
(E) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;
(F) Instructions for use that address where to place the electrodes, what stimulation parameters to use, and duration and frequency of treatment sessions. This information must be based on the results of clinical studies for the device;
(G) A detailed summary of the device technical parameters, including waveform, output mode, pulse duration, frequency, train delivery, and maximum charge and energy; and
(H) Information on validated methods for reprocessing any reusable components between uses.
(vii) Cranial electrotherapy stimulator devices marketed prior to the effective date of this reclassification must have an amendment submitted to the previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
(2) Class III (premarket approval) when intended to treat depression.
(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 19, 2020, for any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 19, 2020, been found to be substantially equivalent to any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
ANNEXURE `IV'
MAY 29 2009
K09005-2
Johari Digital Healthcare Ltd.
ISO 13485 : 2003; 9001 : 2000, FDA USA Regd.
Electronic Hardware Technology Park (100% E.O.U. Unit)
G-582, G-583, EPIP PARK, BORANADA, JODHPUR-342 001 (Raj.) INDIA
Phone : 0291-3209652 • 02931-281567/68, 281531/35/36
Fax : 02931-281539, 0291-2613289
E-mail : sales@joharicara.com :: Info@joharidigital.com
Website : Joharidigital.com
ANNEXURE 'IV'
Traditional 510(k)
SUMMARY
"Traditional 510(k)"
| Labels | Values |
|---|---|
| Submitter's Name | JOHARI DIGITAL HEALTHCARE LTD. |
| Electronic Hardware Technology Park | |
| G-582, 583, | |
| E.P.I.P., Boranada, | |
| Jodhpur-342008 | |
| Phone | +912931281531/36 |
| +912915132424 | |
| Fax | +912931281539 |
| nisha.johari@joharidigital.com | |
| Contact person | Mrs. Nisha Johari |
| Date of Summary Submission | 9th March, 2009 |
| Resubmitting on | N.A. |
MRS. NISHA JOHARI
DIRECTOR MARKETING
JOHARI DIGITAL HEALTHCARE LTD.
Better life for better Today Munufacturer and Exporter of Electro-Medical Devices
4.1
1
NEW DEVICE FOR WHICH SUBMITTING
| Trade Name | : Cranial Electrical Nerve Stimulator |
|---|---|
| Model Name | : FM 10/C |
| Common Name | : CRANIAL ELECTROTHERAPY STIMULATOR AND |
| TRANSCUTANEOUS ELECTRICAL NERVE | |
| STIMULATOR | |
| Classification Name | : Neurology |
| (As Per 21 CFR Sections 882.5800, 882.5890) |
.
LEGALLY MARKETING DEVICE
| CES ULTRA | : | Cranial electrotherapy |
|---|---|---|
| Manufacturer | : | NEURO-FITNESS LLC |
| Address | : | Neuro-Fitness, LLC |
| 33631 SE. Redmond / Fall City Rd. #2, Fall | ||
| City, WA 98024 | ||
| Phone: 425-222-0830, Fax: 425-222-7413 | ||
| Contact: Michael Stevens | ||
| ELECTRONIC PAIN RELIEVERS | : | Transcutaneous |
| Electrical Nerve Stimulator | ||
| Manufacturer | : | JETCO OF AMERICA |
| Address | : | JETCO OF AMERICA |
| 3003 WEST NORTHERN AVE., STE. 5 | ||
| PHOENIX , AZ 85051 |
2
DESCRIPTION OF NEW DEVICE - FM 10/C
FM 10/C is portable Cranial Electrical Nerve Stimulator. FM 10/C combines uniquely two proven therapies CES for the treatment of insomnia, depression, or anxiety and TENS for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain. Thus FM 10/C offers a partnership between Transcutaneous Electrical Nerve Stimulation (TENS) and Cranial Electrotherapy Stimulation (CES).
FM 10/C has three modes viz. (i) TENS Burst (ii) TENS Conventional and (iii) CES mode. It provides easy mode selection through slide switch and user can select any one of the available modes through it. TENS and CES modes will not operate simultaneously so, if CES Leads are inserted then TENS modes are automatically blocked for the user and vice versa.
TENS mode is programmable and user will have the option to select pulse width and pulse rate using analog pots. In addition treatment time is also selectable using a slide switch options available are 30 minutes or continuous treatment time. FM 10/c is only battery operated, with low battery indication.
FM 10/C comes complete with all the necessary components of same quality and standards as being provided with Predicate Device CES Ultra and ELECTRONIC PAIN RELIEVERS to perform Electrical Stimulation. Below is a list of items that are included:
| Sr. Number | Particulars | Quantity |
|---|---|---|
| 1. | FM 10/C Unit | 01 no. |
| 2. | Round Electrode Lead Wire (2 pole, | |
| 116.5 cm, 4mm Diameter Plug) | 02 nos. | |
| 3. | Ear Clip Electrodes (Surface Area 7.9 mm max) | |
| With Round Lead wire (2 Pole, 116.5 cm, | ||
| 5mm Diameter Plug) | 01 nos. | |
| 4. | Electrodes (Round 2") | 04 nos. |
| 5. | Electrode gel (250 ml) | 01 tube |
| 6. | Manual | 01 no. |
The electrodes are legally marketed in U.S., manufactured by:
WANDY RUBBER INDUSTRIAL CO, LTD.
NO.24 , ALLEY 37, LANE 392, FU TEH 1ST RD.,
HSI-CHIH 221, TAIPEI, TAIWAN
3
Traditional 510(k)
Unit FM 10/C is developed to combine the effects of two already established equipments in the market, described as below. The new device is safe and effective and does not introduce new questions of safety and effectiveness.
INTENDED USE
FM 10/C is indicated to be used for:
- CES for the treatment of insomnia, depression, or anxiety. .
- TNS for Symptomatic relief and management of chronic intractable pain and/or . as an adjunctive treatment in the management of post-traumatic and postsurgical acute pain.
| S. No. | Description | New device |
|---|---|---|
| 1. | Power Source | 9 Volts Alkaline Battery |
| 2. | Waveform | TENS: Asymmetrical Biphasic Square |
| Wave. | ||
| CES: Symmetrical Biphasic Square | ||
| Wave. | ||
| 3. | Number of Outputs | Three, 2 for TENS and 1 for CES |
| 4. | Number of Channels | Three, 2 for TENS and 1 for CES |
| 5. | Max output Current | TENS - 100 mA @ 500 Ohms Load |
| CES - 1.5mA @ 2KOhms Load | ||
| 6. | Pulse Width | TENS: 40 $ μS $ to 250 $ μS $ [Selectable] |
| CES: 500 $ μS $ | ||
| 7. | Pulse Rate | TENS: 1 Hz to 140 Hz [Selectable] |
| CES: 100 Hz | ||
| 8. | Treatment Time | Selectable 30 minutes, Continuous, |
| 60 minutes | ||
| 9. | Maximum Phase Charge | TENS: 25 $ μC $ |
| CES: 0.75 $ μC $ @ 2 KΩ | ||
| 10. | Maximum Current Density | TENS: 0.172 mA / cm² @ 500 Ω |
| CES: 3.07 mA/cm² @ 2KΩ | ||
| 11. | Maximum Power Density | TENS: 8.6 mWatt / cm² @ 500 Ω |
| CES: 9.19mWatt/ cm² @ 2 KΩ |
TECHNICAL SPECIFICATION OF THE NEW DEVICE FM 10/C
4
| S.
No. | Description | CES ULTRA | ELECTRONIC PAIN
RELIEVERS |
|-----------|----------------------------|----------------------------------------|---------------------------------------|
| 1. | Power Source | 9 Volts Alkaline
Battery | 9 Volts Alkaline Battery |
| 2. | Waveform | Symmetrical
Biphasic Square
Wave | Asymmetrical Biphasic
Square Wave. |
| 3. | Number of Outputs | One | Two |
| 4. | Number of Channels | One | Two |
| 5. | Max output Current | 1.5mA @ 2KOhms
Load | 100mA @ 500 Ohms Load |
| 6. | Maximum Phase Charge | 0.75 μC @ 2 ΚΩ | 25 μC @ 500 Ohms. |
| 7. | Maximum Current
Density | 3.07 mA/cm² @ 2KΩ | 0.172 mA / cm² @ 500 Ω |
| 8. | Maximum Power Density | 9.19mWatt/ cm² @ 2
KΩ | 8.6 mWatt / cm2 @ 500
Ω |
TECHNICAL SPECIFICATION OF THE PREDICATE DEVICES
: 4.5
' .
5
TECNOLOGIAL CHARACTERISTICS
। . MICRO-CONTROLLER
FM 10/C uses a high-speed microcontroller for all data generation. This makes data or parameters accurate or precise and they do not change over time. In predicate devices, ELECTRONIC PAIN RELIEVERS and CES ULTRA also use a micro controller.
2. MULTICHANNEL
FM 10/C has three outputs. Two dedicated for TENS and one output dedicated for CES. ELECTRONIC PAIN RELIEVERS has only two channels. CES ULTRA has only one channel dedicated for CES.
3. MULTIWAVE SELECTIONS & PROGRAMABILITY
FM 10/C produces selection of TENS and CES. TENS mode has selection of Pulse Width from 40 µS to 250 µS and Pulse Rate from 1 to 140 Hz for pain relief. CES is of Fixed Pulse Width 500 µS and Pulse Rate 100 Hz. Patient can also option of three treatment times 30 minutes, 60 minutes or continuous, which is selectable through slide switch.
ELECTRONIC PAIN RELIEVERS has three modes and has selection of Pulse Width from 40 µS to 250 µS and Pulse Rate from 1 to 140 Hz for pain relief CES ULTRA is meant only for CES, and produces micro current with 100 Hz frequency. Two treatment times can be selected thru switch viz 30 minutes or 45 minutes.
4. DISPLAY
FM 10/C uses stickers and markings on enclosure, for user to see the parameters which he has selected. Low battery and Power ON are indicated thru LED.
ELECTRONIC PAIN RELIEVERS uses stickers and markings on enclosure, for user to see the parameters which he has selected. Low battery and Power ON are indicated thru LED.
CES ULTRA uses stickers and markings on enclosure, for user to see the parameters which he has selected.
5. POWER
FM 10/C, ELECTRONIC PAIN RELIEVERS and CES ULTRA is use +9V alkaline battery.
6
6. KEY PADS
FM 10/C uses Rotary Pots for pulse width, pulse rate & intensity and Sliding switches for mode & treatment time selection.
ELECTRONIC PAIN RELIEVERS uses Rotary Pots for pulse width, pulse rate & intensity and Sliding switches for mode Selection..
CES ULTRA uses rotary Pot for Intensity Control and a Tack switch for time selection.
7. CASING
All three units are attractive and fitted in an ABS body enclosure. They are strong and sturdy. FM 10/C is more friendly and ergonomic designed.
SAFETY
-
- Since FM 10/C operates only on battery, it makes it safe.
-
- TENS mode is disabled once CES electrode Lead is inserted, which makes it more safe to use.
SUMMARY
FM 10/C functions normally after open and short circuited conditions between output jacks, with the device operating for maximum of 15 minutes, in each condition at the maximum available setting of pulse width, pulse rate and pulse amplitude.
A concise detailed design control activities, verification and validation activities are described in next section.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" surrounding it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Johari Digital Healthcare Ltd. % Mrs. Nisha Johari Electronic Hardware Technology Park G-582, 583, E.P.I.P., Boranada Jodhpur, Rajasthan India 342008
MAY 2 9 2009
Re: K090052
Trade/Device Name: Cranial Electrical Nerve Stimulator (FM 10/C) Regulation Number: 21 CFR 882.5800 Regulation Names: Cranial electrotherapy stimulator Regulatory Class: III Product Code: JXK, GZJ Dated: May 22, 2009 Received: May 27, 2009
Dear Mrs. Johari:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
8
Page 2 - Mrs. Nisha Johari
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrl/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Thurber V. Selby
FOR
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Traditional 510(k)
Image /page/9/Picture/2 description: The image shows a logo that says "jobapi digital". The word "jobapi" is written in a cursive font, and there is a line underneath it. The word "digital" is written in a sans-serif font and is smaller than the word "jobapi". There is a registered trademark symbol next to the "i" in "jobapi".
Johari Digital Healthcare Ltd. 150 13485 : 2003; 9001 : 2000, FDA USA Rogd.
Electronic Hardware Technology Park (100% E.O.U. Unit) G-582. G-583. EPIP PARK, BORANADA, JODHPUR - 342 001 (Rej, ) INDIA :: 0291-3209652 - 02931-281567/68, 281531/35/36 : 02031-281538, 0291 - 2813289 : : sales@joharicare.com :: Info@johandigitel.com : joharidigital.com
Indications for Use 10(k) Number (If known): K090052 vice Name: Cranial Electrical Nerve Stimulator (FM 10/C)
- ls indicated to be used for:
- S for the treatment of Insomnia, depression, or anxiety.
- ENS for Symptomatic rellef and management of chronic intractable pain and/or
- an adjunctive treatment in the management of post-traumatic and postsurgical acute pain. Address and so ﺎ ﺗﺄﺛﺮ ﺗﺄﺛﺮ ﺗﺄ
.
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K010022
Prescription Use AND/OR Over-The-Counter Use Part 21 CFR 801 Subpart D) Part 21 CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Same
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Better life for better Tobay Manufacturer and Exporter of Electro-Medical Devices