(94 days)
Not Found
No
The device description focuses on microcomputer control, electrical stimulation parameters, battery management, and user interface, with no mention of AI or ML technologies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "symptomatic relief and management of chronic intractable pain" and "adjunctive treatment in the management of post surgical and post-traumatic, Acute pain condition," which clearly indicates a therapeutic purpose.
No
Explanation: The device description states its purpose is for symptomatic relief and management of pain, not for identifying or diagnosing a condition.
No
The device description explicitly states it is a "Microcomputer controlled portable two channel electrical stimulator" and mentions hardware components like rechargeable batteries, an external charger, a rubber key pad, and an LCD. This indicates it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "symptomatic relief and management of chronic intractable pain" and "adjunctive treatment in the management of post surgical and post-traumatic, Acute pain condition." This describes a therapeutic device used on the body, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details an "electrical stimulator" that applies electrical signals to the patient. This is consistent with a therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, INFREX is a therapeutic device, specifically an electrical stimulator, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- "Symptomatic relief and management of chronic intractable pain."
- "Adjunctive treatment in the management of post surgical and post-traumatic, Acute pain condition."
Product codes (comma separated list FDA assigned to the subject device)
GZJ, LIH
Device Description
"INFREX is a Microcomputer controlled portable two channel electrical stimulator. It allows the treatment specifically tailored to the precise needs of the patient. The unique feature of this unit is that it is supplied with two removable packs of rechargeable batteries and an external charger. The user can put one battery pack in the unit for reatment and another spare pack can be charged outside the unit using the supplied external charger. This system facilitates the user to have charged batteries always available and the treatment can be aak any time. Often the units available in the market consume lot of power and batteries die fast. The Rubber Key Pad operation and LCD protocols makes the use and programming easy and simple. All the parameters remain in the system control except the amplitude & time selectable, which can be set by the patient himself. The ergonomic design makes this unit very comfortable to worn and carry."
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image shows a logo with two hands shaking above the text "Jo-hapi digital". The word "Jo-hapi" is written in cursive, and the word "digital" is written in a sans-serif font. There is a registered trademark symbol next to the word "hapi".
Image /page/0/Picture/1 description: The image contains two logos and the text "ISO 9001 Certified" below them. The logo on the left contains the letter R inside a circle, surrounded by text. The logo on the right contains a crown above a check mark, with the text "UKAS Quality Management" below it.
Johari Digital Healthcare Ltd.
REGD. OFFICE : EC-1,2,3, Electronics Complex, Light Industrial Area, Jodhpur - 342003 (Raj) INDIA Phone : 91-291-741183,748314(f) Fax : 742289 e-mail : joharis@ndf.vsnl.net.in Website : www.jo-hari.com
MAY - 5 2005
| Traditional 510(k) | ANNEXURE 'VIII' |
|---|---|
| -------------------- | ----------------- |
SUMMARY
"Traditional 510(k) Summary"
| Submitter's name | JOHARI DIGITAL HEALTHCARE LTD. |
|---|---|
| Address | EC-1-2-3, Electronics Complex |
| Light Industrial Area | |
| Jodhpur - 342003 INDIA | |
| TELEPHONE | +91-2931-281535, 281536 |
| FAX | +91-291-2742289 |
| pjohari@gmail.com; nisha.johari@gmail.com | |
| Contact Person | Pooja Johari |
| Date of Summary is submitted | January 18, 2006 |
| Resubmitting on |
Nisha Jahain
8.1
.....
જ
1
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ANNEXURE 'VIII'
NEW DEVICE FOR WHICH SUBMITTING
| Trade Name | : INFREX |
|---|---|
| Common Name | : Interferential & Transcutaneous Electrical Nerve Stimulator |
| Classification Name | : Neurology (Per 21 CFR Section 882-5890). |
| Distributed by | : MedFaxx, Inc. |
| P. O. Box 1289 | |
| Wake Forest, N. C. 27588 | |
| tel: 800-937-3993 tel2:919-570-0350 | |
| fax: 919-570-0354 | |
| bobjohnson@medfaxxinc.com | |
| http://www.medfaxxinc.com |
LEGALLY MARKETED DEVICE
| TENS TS1211 | : Transcutaneous Electrical Nerve Stimulator
510(k) Number K021755 |
|-------------------------|-----------------------------------------------------------------------|
| Manufacturer
Address | : Apex Medical Corp., Taiwan
P.O.Box, 18-17
Taipei, Taiwan |
| IF-4000 | : Interferential Stimulator |
510(k) Number K952683
Manufacturer Address
:
:
.
"、
·
Apex Medical Corp., Taiwan P.O.Box, 18-17 Taipei, Taiwan
.
8.2
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2
DEVICE DESCRIPTION
INFREX is a Microcomputer controlled portable two channel electrical stimulator. It allows the treatment specifically tailored to the precise needs of the patient.
The unique feature of this unit is that it is supplied with two removable packs of rechargeable batteries and an external charger. The user can put one battery pack in the unit for reatment and another spare pack can be charged outside the unit using the supplied external charger. This system facilitates the user to have charged batteries always available and the treatment can be aak any time. Often the units available in the market consume lot of power and batteries die fast.
The Rubber Key Pad operation and LCD protocols makes the use and programming easy and simple. All the parameters remain in the system control except the amplitude & time selectable, which can be set by the patient himself. The ergonomic design makes this unit very comfortable to worn and carry.
INFREX comes complete with all the necessary components to perform Pain Management Stimulation. Below is a list of items that are included:
| Quantity | ||
|---|---|---|
| 1. | INFREX unit | 01 |
| 2. | Electrode Cable (2 pole, length-1.15m) | 02 |
| 3. | Electrode (Self Adhesive, size -2" round) | 04 |
| 4. | Rechargeable batteries AAA (Ni-Mh) | 02 packs, (4 in each pack) |
| 5. | External Charger | 01 |
| 6. | Carry Bag | 01 |
| 7. | Manual | 01 |
3
Traditional 510(k) - K060246
Indications for Use
510(k) Number (if known): - K060246
Device Name: INFREX INFREX is indicated to be used for: -
- Symptomatic relief and management of chronic intractable pain.
- 트 Adjunctive treatment in the management of post surgical and post-traumatic, Acute pain condition.
4
. . .
de proposition de l'Andre de l'Annexure 'VII'
TECHNICAL SPECIFICATIONS OF NEW DEVICE INFREX
.
| Power Source: | 1.2 Volts * 4Ni - Mh battery pack. |
|---|---|
| Number of outputs: | Two |
| Channels | Two |
| Synchronous | Yes |
| Max Output Current: | TENS |
| (Peak to Peak) | 60 mA @ 500 Ohms. |
| 24mA @ 2K Ohm. | |
| 5.4mA @10K Ohm. | |
| IFT | |
| 54 mA @ 500 Ohms. | |
| 21mA @2 2K Ohm. | |
| 4.4mA @10K Ohm. | |
| Max Output Voltage: | LENS |
| (Peak to Peak) | 30 V @ 500 Ohms. |
| 48V @ 2K Ohm. | |
| 54V @10K Ohm. | |
| IFT | |
| 27V @ 500 Ohms Load. | |
| 42V @ 2K Ohm. | |
| 44V @10K Ohm. | |
| Channel isolation | Yes, confirm to ANSI 3.2.3.2 , 1985 |
| Waveform | Symmetrical Biphasic Square Wave |
| Pulse width | TENS |
| 50, 100, 150, 200 and 250 uS selectable. | |
| IFT | |
| 125 µS. | |
| Frequency | TENS |
| 5 and 60 Hz selectable | |
| IFT | |
| Channel 1: 4000 Hz. | |
| Channel 2: 4080 to 4150 Hz. | |
| જે રે | |
| Max. Phase charge | TNS |
| 7.500 μC @ 500 Ohms Load. | |
| 3.000 μC @ 2K Ohms Load. | |
| 0.675 μC @ 10K Ohms Load. | |
| IFT | |
| 3.375 μC @ 500 Ohms Load. | |
| 1.312 μC @ 2K Ohms Load. | |
| 0.275 μC @ 10K Ohms Load. | |
| Current Density on 2" | |
| Electrodes: | TENS |
| 0.089 mA / cm2 @ 500 Ohms Load. | |
| 0.0355 mA / cm2 @ 2K Ohms Load. | |
| 0.008 mA / cm2 @ 10K Ohms Load. | |
| IFT | |
| 2.66 mA / cm2 @ 500 Ohms Load. | |
| 1.036 mA / cm2 @ 2K Ohms Load. | |
| 0.217 mA / cm2 @ 10K Ohms Load. | |
| Power Density on 2" | |
| Electrodes: | TENS |
| 0.0027 Watt / cm2 @ 500 Ohms Load. | |
| 0.0017 Watt / cm2 @ 2K Ohms Load. | |
| 0.0004 Watt / cm2 @ 10K Ohms Load. | |
| IFT | |
| 0.0718 Watt / cm2 @ 500 Ohms Load. | |
| 0.0435 Watt / cm2 @ 2K Ohms Load. | |
| 0.0095 Watt / cm2 @ 10K Ohms Load. | |
| Modulation Options: | |
| Amplitude | |
| Frequency | Applicable only in IFT Mode. |
"
.
5
,
6
ANNEXURE 'VII'
TECHNICAL SPECIFICATIONS OF PREDICATE DEVICE TENSITS 1211
| Power Source: | +9 Volts Alkaline Battery or Ac Adaptor |
|---|---|
| Number of outputs: | Two |
| Channels | Two |
| Synchronous | Yes |
| Max Output Current: | |
| (Peak to Peak) | 80 mA @ 500 Ohms Load |
| Max Output Voltage: | |
| (Peak to Peak) | 40 V @ 500 Ohms Load. |
| Channel isolation | Yes, confirm to ANSI 3.2.3.2, 1985. |
| Waveform | Asymmetrical Biphasic Square Wave |
| Pulse width | 50 to 300 uS. |
| Frequency | 2 to 150 Hz. |
| Max. Phase charge | 24.000 uc @ 500 Ohms Load. |
| Current Density on 2" | |
| Electrodes: | 0.355 mA / cm2 @ 500 Ohms Load. |
| Power Density on 2" | |
| Electrodes: | 0.0142 Watt / cm2 @ 500 Olims Load. |
| Modulation Options: | |
| Amplitude | Not Applicable |
| Frequency | |
| Mechanical Specifications | 3.9" x 2.75" x 1" (L x B x H) |
7
ANNEXURE 'VIII'
TECHNICAL SPECIFICATIONS OF PREDICATE DEVICE IF-4000
| Power Source: | +9 Volts Alkaline Battery or Ac Adaptor |
|---|---|
| Number of outputs: | Two |
| Channels | Two |
| Synchronous | Yes |
| Max Output Current: | |
| (Peak to Peak) | 32 mA @ 500 Ohms Load |
| Max Output Voltage: | |
| (Peak to Peak) | 16 V @ 500 Ohms Load. |
| Channel isolation | Yes, confirm to ANSI 3.2.3.2, 1985. |
| Waveform | Symmetrical Biphasic/Square Wave |
| Pulse width | 125 μS. |
| Frequency | Channel 1: 4000 Hz |
| Channel 2: Channel 1 + (-55% of Sweep Frequency to +25% of | |
| Sweep Frequency). Sweep Frequency is selectable thru rotary | |
| Knob in between 1 to 150 Hz. | |
| Max. Phase charge | 4.00 μc @ 500 Ohms Load. |
| Current Density on 2" | |
| Electrodes: | 1.578 mA / cm2 @ 500 Ohms Load. |
| Power Density on 2" | |
| Electrodes: | 0.02525 Watt / cm2 @ 500 Ohms Load. |
| Modulation Options: | |
| Amplitude | |
| Frequency | Amplitude Modulation thru Slide Switch.. |
| Mechanical Specifications | 3.74" x 2.52" x 0.95 (L x B x H) |
8
TECHNOLOGICAL CHARACTERISTICS
MICRO-CONTROLLER 1.
MICRO-CONTROLEN
INFREX 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, TENS 1211 also uses a micro controller, but IF 4000 is an analog devices and the precision of data is not as much as in INFREX.
MULTICHANNEL 2.
INFREX & TENS TS1211 & IF-4000 have two channels to provide Interferential INFREX & TENS TOO body area. Similarly in INFREX and both predicate devices have two channels to provide TENS stimulation to treat two body areas.
MULTIWAVE SELECTIONS & PROGRAMABILITY 3.
MULTIWAVE SELECTIONS of Interferential Stimulation (frequency of 4000 Hz and one fixed beat frequency 80Hz to 150 Hz. Sweep) and TENS of two selectable frequency - 5Hz and 60Hz (Default 60Hz) waveforms for pain relief through both the outputs.
Predicate device IF-4000 provides Base frequency of 4000 Hz, and sweep or beat frequency I routent of 1 to 250 Hz thru Rotary Potentiometer (Knob). Also sweep time can be selected school of 1 to 200 12 ar 10/10. In TENS TS1211 provides pulse width selection from 50 as 171, Continuous, 07 of Ferrersy from 2 to 150 Hz, along with 5 different modes and treatment time.
4. DISPLAY
DISTEAT Mode, PW, PR, Treatment Time and battery status.
Mode, I n, I r, I readinent raily LED indication to show ON/OFF and Low Battery Status.
ડ. POWER
INFREX works on rechargeable battery back up, so the treatment will not be limited to site near AC outlet and can be carried along. Similarly TENS TS1211 operates only on +9 Volts alkaline battery and IF-4000 operates on +9V alkaline battery or AC Adaptor option.
RUBBER KEY PADS 6.
ROBER RET FADS INNEX and TEAK and Sliding switches for mode or frequency selection, which limits there life.
7. CASING
All three units are attractive and fitted in an ABS body enclosure. They are strong and sturdy. INFREX is more ergonomic designed.
8.9
9
ANNEXURE 'VIII'
SAFETY
-
- Since INFREX operates only on Rechargeable battery, it makes it safer then its Predicate devices.
-
- Rubber Key Pad is provided which is known to withstand longer than other mechanical methods and has much more life cycle.
-
- Circuitry efficiency is good as matrix circuitry is used in keyboard & amplification circuitry is simple.
SUMMARY
INFREX has a self-contained safety circuit.
Open/short circuit performance: This INFREX 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 is described in next section.
8.10
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Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2006
Johari Digital Healthcare Ltd. c/o Pooja Johari 7131 Farralone Avenue, # 48 Canoga Park, California 91303
Re: K060246 Trade/Device Name: Infrex Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: GZJ, LIH Dated: April 21, 2006 Received: April 24, 2006
Dear Ms. 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, 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
11
Page 2 - Pooja Johari
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 (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Pare 807.9 Tour 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/industry/support/index.html.
Sincerely yours.
Herbert Lehman us
/ Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
12
ANNEXURE 'VI'
Traditional 510(k) - K060246
Indications for Use
510(k) Number (if known): - K060246
Device Name: INFREX
INFREX is indicated to be used for: -
- Symptomatic relief and management of chronic intractable pain. ■
- Adjunctive treatment in the management of post surgical and post-traumatic, 비 Acute pain condition.
Halesh Kumar MD
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K060246
Prescription Use AND/OR Over-The-Counter Use > (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of