(94 days)
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, Acute pain condition.
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.
The provided document is a 510(k) summary for the INFREX device, a Transcutaneous Electrical Nerve Stimulator (TENS) and Interferential Stimulator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way a new, high-risk device might.
Therefore, the document does not contain a traditional "study that proves the device meets the acceptance criteria" in the sense of a clinical trial with statistical endpoints for AI performance. Instead, it relies on demonstrating that the new device has the same intended use and similar technological characteristics as predicate devices, and that any differences do not raise new questions of safety or effectiveness.
However, I can extract information related to the acceptance criteria (defined by the substantial equivalence comparison) and the device's technical specifications as its "reported performance" in a comparative context.
Here's an analysis based on the provided text, addressing your points where data is available:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for substantial equivalence, "acceptance criteria" are implicitly defined by the technical specifications and performance characteristics of the predicate devices. The new device (INFREX) must demonstrate similar performance or that any differences do not raise new safety/effectiveness concerns.
Here's a comparison of key technical specifications, where INFREX's performance is implicitly "accepted" if it is similar to or an improvement upon the predicate devices, or if the differences are justified as safe and effective.
| Characteristic | Acceptance Criteria (Predicate TENS TS1211) | Acceptance Criteria (Predicate IF-4000) | Reported Device Performance (INFREX) |
|---|---|---|---|
| Power Source | +9 Volts Alkaline Battery or AC Adaptor | +9 Volts Alkaline Battery or AC Adaptor | 1.2 Volts * 4 Ni - Mh battery pack (rechargeable). Safety advantage claimed. |
| Number of outputs | Two | Two | Two |
| Channels | Two | Two | Two |
| Synchronous | Yes | Yes | Yes |
| Max Output Current | 80 mA @ 500 Ohms Load | 32 mA @ 500 Ohms Load | TENS: 60 mA @ 500 Ohms, 24mA @ 2K Ohm, 5.4mA @10K Ohm. IFT: 54 mA @ 500 Ohms, 21mA @2K Ohm, 4.4mA @10K Ohm. (Higher for IFT mode than IF-4000, lower for TENS mode than TENS TS1211) |
| Max Output Voltage | 40 V @ 500 Ohms Load | 16 V @ 500 Ohms Load | TENS: 30 V @ 500 Ohms, 48V @ 2K Ohm, 54V @10K Ohm. IFT: 27V @ 500 Ohms Load, 42V @ 2K Ohm, 44V @10K Ohm. (Higher for IFT mode than IF-4000, lower for TENS mode than TENS TS1211 at 500 Ohms and 2K Ohms) |
| Channel isolation | Yes, conform to ANSI 3.2.3.2, 1985. | Yes, conform to ANSI 3.2.3.2, 1985. | Yes, conform to ANSI 3.2.3.2, 1985. |
| Waveform | Asymmetrical Biphasic Square Wave | Symmetrical Biphasic/Square Wave | Symmetrical Biphasic Square Wave (Matches IF-4000, differs from TENS TS1211) |
| Pulse width | 50 to 300 uS | 125 μS | TENS: 50, 100, 150, 200 and 250 uS selectable. IFT: 125 µS. (TENS range generally within predicate TENS, IFT matches predicate IF-4000) |
| Frequency | 2 to 150 Hz | Ch1: 4000 Hz, Ch2: 4080 to 4150 Hz variable beat (1-150Hz sweep selectable) | TENS: 5 and 60 Hz selectable. IFT: Ch1: 4000 Hz, Ch2: 4080 to 4150 Hz. (Fixed beat frequency 80Hz to 150 Hz sweep stated in "Multiwaves" section, not granularly listed in table) (TENS frequency range is narrower than predicate TENS, IFT frequencies are very similar to predicate IF-4000) |
| Max. Phase charge | 24.000 µC @ 500 Ohms Load | 4.00 µC @ 500 Ohms Load | TENS: 7.500 µC @ 500 Ohms. IFT: 3.375 µC @ 500 Ohms. (Lower for TENS mode than predicate TENS, similar for IFT mode to predicate IF-4000) |
| Current Density (2" Elec) | 0.355 mA / cm2 @ 500 Ohms Load | 1.578 mA / cm2 @ 500 Ohms Load | TENS: 0.089 mA / cm2 @ 500 Ohms Load. IFT: 2.66 mA / cm2 @ 500 Ohms Load. (Lower for TENS, higher for IFT) |
| Power Density (2" Elec) | 0.0142 Watt / cm2 @ 500 Ohms Load | 0.02525 Watt / cm2 @ 500 Ohms Load | TENS: 0.0027 Watt / cm2 @ 500 Ohms Load. IFT: 0.0718 Watt / cm2 @ 500 Ohms Load. (Lower for TENS, higher for IFT) |
| Microcontroller | TENS TS1211: Yes, IF-4000: No (Analog) | Yes, high-speed for accuracy and precision (stated as an improvement over analog IF-4000). | |
| Safety Circuit | Not explicitly detailed, but assumed per standards | Not explicitly detailed, but assumed per standards | Self-contained safety circuit. Open/short circuit performance confirmed (functions normally after open/short circuited conditions for 15 mins at max settings). |
| Indications for Use | Symptomatic relief and management of chronic intractable pain. Acute pain condition. | Symptomatic relief and management of chronic intractable pain. Acute pain condition. | Symptomatic relief and management of chronic intractable pain. Adjunctive treatment in the management of post surgical and post-traumatic, acute pain condition. (Identical to predicate devices) |
Study Information (Based on 510(k) Submission Type)
This is a Traditional 510(k) submission (K060246) for medical device clearance, not a clinical trial report for an AI algorithm. The "study" here refers to the engineering, design controls, and comparison to predicate devices, rather than a clinical performance study with human subjects validating specific metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k). The document describes technical specifications and design verification, not a clinical test set from patient data.
- Data Provenance: Not applicable. The data presented is engineering specifications and comparisons to predicate devices, not clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is an electrical stimulator, not an AI diagnostic tool requiring expert ground truth for interpretation of images or other complex data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No "test set" in the context of expert adjudication is mentioned. The device's technical specifications are verified through engineering tests and comparison to recognized standards (e.g., ANSI 3.2.3.2, 1985).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-assisted diagnostic or interpretive device. It is a physical electrical stimulator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm. It's a medical device with fixed operational parameters and control by the patient (for amplitude & time) or clinician. The "microcontroller" discussed enhances precision, but it's not an AI performing clinical tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is adherence to recognized electrical and safety standards (e.g., ANSI 3.2.3.2, 1985 for channel isolation) and demonstration of similar or improved technical performance characteristics compared to legally marketed predicate devices, verifying that the device functions as intended and safely delivers the specified electrical stimulation. This is validated through engineering design and testing, as described implicitly by the "design control activities, verification and validation activities" mentioned in the "Safety" section.
8. The sample size for the training set
- Not applicable. There is no AI model being trained with a dataset.
9. How the ground truth for the training set was established
- Not applicable. There is no AI model being trained with a dataset.
Summary of what the document does describe for acceptance and proof:
Instead of clinical study data for AI, the document focuses on:
- Substantial Equivalence: The primary "acceptance criteria" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is proven by showing:
- Identical Indications for Use: INFREX has the exact same Indications for Use as its predicate devices.
- Similar Technological Characteristics: A detailed comparison of technical specifications (output current, voltage, waveform, pulse width, frequency, etc.) is provided to show that INFREX is technologically similar to the predicate devices.
- Resolution of Differences: Where there are differences (e.g., power source - rechargeable batteries; microcontroller for precision; specific parameter ranges), the submitter argues these differences do not raise new questions of safety or effectiveness, and in some cases, are presented as improvements (e.g., rechargeable batteries for portability, microcontroller for precision over analog).
- Safety and Performance Testing: The document mentions "design control activities, verification and validation activities" and specifically notes open/short circuit performance testing ("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"). This confirms the device's electrical safety and functional integrity under specific fault conditions. Compliance with standards like ANSI 3.2.3.2, 1985 for channel isolation is also stated.
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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 ComplexLight Industrial AreaJodhpur - 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
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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 1289Wake Forest, N. C. 27588tel: 800-937-3993 tel2:919-570-0350fax: 919-570-0354bobjohnson@medfaxxinc.comhttp://www.medfaxxinc.com |
LEGALLY MARKETED DEVICE
| TENS TS1211 | : Transcutaneous Electrical Nerve Stimulator510(k) Number K021755 |
|---|---|
| ManufacturerAddress | : Apex Medical Corp., TaiwanP.O.Box, 18-17Taipei, Taiwan |
| IF-4000 | : Interferential Stimulator |
510(k) Number K952683
Manufacturer Address
:
:
.
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·
Apex Medical Corp., Taiwan P.O.Box, 18-17 Taipei, Taiwan
.
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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 |
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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.
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. . .
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 | TNS7.500 μC @ 500 Ohms Load.3.000 μC @ 2K Ohms Load.0.675 μC @ 10K Ohms Load. |
| IFT3.375 μC @ 500 Ohms Load.1.312 μC @ 2K Ohms Load.0.275 μC @ 10K Ohms Load. | |
| Current Density on 2"Electrodes: | TENS0.089 mA / cm2 @ 500 Ohms Load.0.0355 mA / cm2 @ 2K Ohms Load.0.008 mA / cm2 @ 10K Ohms Load. |
| IFT2.66 mA / cm2 @ 500 Ohms Load.1.036 mA / cm2 @ 2K Ohms Load.0.217 mA / cm2 @ 10K Ohms Load. | |
| Power Density on 2"Electrodes: | TENS0.0027 Watt / cm2 @ 500 Ohms Load.0.0017 Watt / cm2 @ 2K Ohms Load.0.0004 Watt / cm2 @ 10K Ohms Load. |
| IFT0.0718 Watt / cm2 @ 500 Ohms Load.0.0435 Watt / cm2 @ 2K Ohms Load.0.0095 Watt / cm2 @ 10K Ohms Load. | |
| Modulation Options:AmplitudeFrequency | Applicable only in IFT Mode. |
"
.
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,
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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 |
| FrequencyMechanical 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 HzChannel 2: Channel 1 + (-55% of Sweep Frequency to +25% ofSweep Frequency). Sweep Frequency is selectable thru rotaryKnob 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:AmplitudeFrequency | Amplitude Modulation thru Slide Switch.. |
| Mechanical Specifications | 3.74" x 2.52" x 0.95 (L x B x H) |
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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
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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
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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
§ 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).