(494 days)
No
The description details standard electrical stimulation modalities and parameters without mentioning any adaptive, learning, or data-driven features characteristic of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for symptomatic relief and management of pain, muscle spasm, and prevention of disuse atrophy, which are therapeutic applications.
No
The device description and intended use indicate that the ANALGESIC PULSER AP-439 is an electrical stimulator used for therapeutic purposes (pain relief, muscle stimulation) rather than for diagnosing conditions.
No
The device description explicitly states it is an "electrical nerve muscle stimulator with two outputs and four channels" and details various hardware specifications like waveforms, modes of stimulation, maximum output current and voltage, and modulation options. This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the ANALGESIC PULSER AP-439 is an electrical nerve muscle stimulator. It applies electrical currents to the body for therapeutic purposes (pain relief, muscle stimulation).
- Intended Use: The intended uses listed are all related to applying electrical stimulation to the body for various physical therapy and pain management applications. There is no mention of analyzing samples from the body.
Therefore, this device falls under the category of a therapeutic electrical stimulator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
(A) Interferential current stimulation, Premodulated Bipolar Mode and Faradic Stimulation Mode is indicated for:
- Symptomatic relief and management of chronic (long term) intractable pain.
- Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions.
(B) Electrical Muscle Stimulation (Russian and Galvanic-Interrupted) is indicated for:
- Relaxation of Muscle spasm.
- Prevention or Retardation of disuse atrophy.
- Increasing local blood circulation.
- Muscle re-education.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- Maintaining or increasing range of motion.
(C) Galvanic-DC Continuous mode is indicated for:
- Relaxation of muscle spasm.
Product codes
GZJ, IPG, LIH
Device Description
Not Found
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
Physical Medicine by Clinicians and Therapists.
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)
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
MAR - 2 2001
510 (K):K993229(Revised submission)
。
SUMMARY
JOHARI ELECTRO TECH CO.
EC-2, Electronics Complex, Light Industrial Arca, Jodhpur 342003 (INDIA) PHONE: -91-291-741183 (F), 430028 (R) I AX: 91-291-742289 E-mail: joharis@ndf.vsnl.net.in
"510(k) Summary"
| Submitter's name | JOHARI ELECTRO TECH CO. |
|---|---|
| Address | EC-2, Electronics Complex |
| Light Industrial Area | |
| Jodhpur 342003 | |
| INDIA | |
| Phone | 91-291-741183 |
| FAX | 91-291-742289 |
| joharis@ndf.vsnl.net.in | |
| Contact Person | Mrs. Nisha JOHARI |
| Date of Summary | |
| is submitted | Resubmitting on August 9th 2000 |
1
Device for which clearance is required
| Trade Name : | Analgesic Pulser AP-439 |
|---|---|
| Common Name : | Electrical Nerve Muscle Stimulator |
| Classification Name : | Physical Medicine (Per 21 CFR Section 890) and |
| Neurology (Per 21 CFR Section 882.5890). |
Legally Marketed Device I
| (a) Sys stim 226
| (b) Sys stim 206 | : | Muscle Stimulator | 510(k) Number K964028 |
|---|---|---|---|
| Manufacturer | : | Mettler Electronics Corp. | |
| Address | : | 1333 S. Claudia St. Anaheim Ca. 92805 | |
| Tel. | : | 001 (714) 533 2221 |
AP-439 has same intended use as predicate. Both the electrical stimulators are to be used in Physical Medicine by Clinicians and Therapists.
Intended Use of Sys Stim 226 and 206
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential or Premodulated Waveforms).
- Temporary relaxation of muscle spasm. 2.
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscies.
-
- Increase of blood flow in the treatment area.
-
- Prevention or retardation of disuse atrophy in post-injury type conditions.
-
- Muscle re-education.
-
- Maintaining or increasing range of motion.
Legally Marketed Device II:
Sportx
: Pulsed Direct Current (Muscle) and Nerve Stimulator
Manufacturer : Staodyn
2
ANNEXURE 'VIT
: 1225 Florida Avenue, Longmont, Colorado 80502-1379, 1-800-Address: 343-0488 or 1-800-525-2114
The predicate Device Sportx from Staodyn is indicated for
Pulsed Direct Current (PDC) has been used successfully for many years for the reduction of edema, increase or decrease in blood flow, increase in range of motion and relief of muscle spasm. Transcutaneous Electrical Nerve Stimulation (TENS) has been used successfully for many years in the symptomatic relief and management of chronic, intractable pain or as an adjunctive treatment in the management of chronic, intractable pain or as an adjunctive treatment in the management of acute post-surgical or post-traumatic pain.
AP-439 --------
Indication for Use_(A) Interferential current stimulation, Premodulated Bipolar Mode and Faradic Stimulation Mode is indicated for:
- Symptomatic relief and management of chronic (long 1. term) intractable pain.
- Adjunctive treatment in the management of post-2. surgical and post-traumatic, acute pain conditions.
(B) Electrical Muscle Stimulation ( Russian and Galvanic-Interrupted ) is indicated for:
- Relaxation of Muscle spasm. 1.
- Prevention or Retardation of disuse atrophy. 2.
- Increasing local blood circulation. 3.
- Muscle re-education. 4.
- Immediate post-surgical stimulation of calf muscles ળં to prevent venous thrombosis.
- Maintaining or increasing range of motion 6.
( C) Galvanic-IX Continuous mode is indicated for :-
- Relaxation of muscle spasm. 1.
3
ANNEXURE 'VIT
TECHNICAL SPECIFICATIONS
ANALGESIC PULSER AP-439
| Power Source | : 110V AC +/- 50Hz - 60Hz |
|---|---|
| Number of outputs | : Two |
| Channels | : Four |
| Synchronous | : Yes |
| Max out put current | : Faradic - 100 mA pp at 500 Ohm Load |
| Interferential - 72mA RMS (Root Mean Square) | |
| at 500 Ohm Load | |
| DC continuous - 30 mA at 500 Ohm Load | |
| DC Interrupted - 92 mA at 500 Ohm Load | |
| Max out put voltage | : Faradic - 132 V peak to peak at load of 10K ohms |
| Interferential - 50 V RMS at load of 10K ohms | |
| DC continuous - 28 V at load of 10K ohms | |
| DC Interrupted - 60 V at load of 10K ohms. | |
| Channel isolation | : Yes, confirm to ANSI 3.2.3.2 , 1985. |
| Waveform | : Monophasic, Biphasic, Sinewave & D.C. Line |
| Current density | |
| on 2" diameter | |
| electrodes | : Interferential |
| 3.55mA/Sq. cm on 500 ohm load | |
| Galvanic (D.C. continuous) | |
| 1.5 mA/Sq. cm on 500 ohm load | |
| Galvanic Interrupted | |
| 2.1mA/ Sq.cm on 500 Ohm Load | |
| Faradic (Narrow Low Freq, | |
| Wide Low Freq., Dual, Ramp Burst | |
| Paired, Surge) | |
| 0.592 mA/Sq. cm on 500 ohm load | |
| Power density | |
| on 2" diameter | |
| electrodes | Interferential |
| 0.127 W/Sq. cm on 500 ohm load | |
| Galvanic (DC Continuos) | |
| 0.022 W/Sq. cm on 500 ohm load | |
| Galvanic (DC Interrupt) | |
| 0.095 W/Sq. cm on 500 ohm load | |
| Faradic (Narrow Low Freq, | |
| Wide Low Freq., Dual, Ramp Burst | |
| Paired, Surge) | |
| 0.029 W/Sq. cm on 500 ohm load | |
| Max. phase charge | Interferential (Quadipolar, vector, premod) |
| at 500 Ohm | 4.5 micro coulomb |
| at 2 K Ohm | 1.5micro coulomb |
| at 10 K Ohm | 0.3micro coulomb |
| Interferential (Russian) | |
| at 500 Ohm | 7.2 micro coulomb |
| at 2 K Ohm | 2.4micro coulomb |
| at 10 K Ohm | 0.5 micro coulomb |
| Galvanic (DC interrupted) | |
| at 500 Ohm | 40 micro coulomb |
| at 2 K Ohm | 15 micro coulomb |
| at 10 K Ohm | 3.2 micro coulomb |
| Faradic (Narrow Low Freq, | |
| Wide Low Freq., Dual, Ramp Burst | |
| Paired, Surge) | |
| at 500 Ohm | 20 micro coulomb |
| at 2 K Ohm | 9.6 micro coulomb |
| at 10 K Ohm | 3 micro coulomb |
| Modulation Options | |
| Amplitude | Preset IFT only |
| Frequency | IFT section only |
| Mechanical Specifications | Weight 5.5 Lb, 12.2" (l)X 3.5" (h)X 7.5" (d) |
| Pulse width | Faradic: 100-400 (selectable) |
| IFT : 125 micro sec. phase interval | |
| Russian :200Micro Seconds | |
| Galvanic : D.C. |
4
ANNEXURE 'VII
510 (K):K993229(Revised submission)
5
ANNEXURE 'VIT
DC interrupted: At values greater than 50%power the on DC interrupted. An values go the total time is 3.5 milli secs. At values lower than the 50 % power the on time is 800 micro secs. and total time is 3.5 millisecs.
Sys stim: 226
| Waveform: | Sinewave and biphasic rectangular pulse |
|---|---|
| Volts: | 65 V RMS at 1 K load (interferrential mode), 99 V pp at load of 1K ohms.(biphasic mode) 0-50 V RMS at 1 K ohms load.(Russian ,premodulated mode) |
| Current: | 65 mA RMS at 1 K load (interferrential mode), 99 mA peak at load of 1K ohms.(biphasic mode).0-50 mA RMS at 1 K ohms load.(Russian ,premodulated mode |
| Average current at | |
| Max. intensity & freq.: | 65 mA (interferrential mode), 7.2 mA(biphasic mode) |
| 50 mA.(Russian ,premodulated mode) | |
| Max. current density : | |
| Under 2" diameter | |
| Electrode: | 3.2 mA/cm2 (interferrential mode), 0.36 mA/cm2(biphasic mode) |
| 2.5 mA/cm2.(Russian ,premodulated mode | |
| Phase duration: | 125 us (interferrential mode) ,50 -- 300 us (biphasic mode) |
| 200 mA.(Russian ) | |
| Sys Stim 206 | |
| Waveform: | Biphasic,monophasic pulse,DC. |
| Volts: | 0 -- 102 VDC |
| Current: | 100 mA peak, All pulsed Waveforms. |
| 30 mA max. in Dc continuos. |
Average current at: Max. intensity and freq.
6
ANNEXURE 'VIT
510 (K):K993229(Rcviscd submission)
:
Max. current density: Under 2" diameter Electrode:
| Phase duration: | Narrow pulse: 100 us followed by 400 us at ¼ amplitude of reverse polarity.
Wide pulse: 300 us followed by 1200 us at ¼ amplitude of reverse polarity.
AC: 300 us in each polarity
DC: DC Continuous |
| ----------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Sports
| Waveform: | Multiplexed symmetrical rectangular biphasic and unbalanced
symmetrical rectangular triphasic. |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Volts: | 100 V at load of 2 K ohms. |
| Current : | 100 mA at load of 500 ohms. |
| Average current at:
Max. intensity & freq. | ---- |
| Max. current density
Under 2" diameter
Electrode: | ---- |
| Phase duration: | Symmetrical biphasic: 1800 us
Unbalanced triphasic 1800 us and 900 us |
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/7/Picture/2 description: The image shows a black and white logo. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The bird is encircled by text, which appears to be part of the logo's design. The text is arranged in a circular fashion around the bird, completing the overall design of the logo.
MAR - 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nisha Johari Director of Marketing Johari Electro-Tech Company Vandana, 28 Nehru Park Jodhpur-342003, India
Re: K993229 Trade Name: Analgesic Pulser, Model AP-439 Regulatory Class: II Product Code: GZJ, IPG and LIH Dated: December 1, 2000 Received: December 5, 2000
Dear Ms. Johari:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have heve hour your books. Is substantially equivalent (for the indications for use above and we have active as marketed in interstate commerce prior to May 28, 1976, the shared in the onemales) to concession incents, or to devices that have been reclassified in enacinent daily of the Modical Dortes Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer and act reasyode requirements for annual registration, listing of devices, Controlis of the rest the receive, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarker ripp. over device the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mispections) the Food and Date in any result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate device results in a classification for your device and thus, permits your device to proceed to the market.
8
Page 2 - Ms. Nisha Johari
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Miriam C. Provost
for 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
9
ANNEXURE VIT
DEVICE NAME: ANALGESIC PULSER AP-439
INDICATION FOR USE . (A) Interferential current stimulation , Premodulated Bipolar Mode and Faradic Stimulation Mode is indicated for,
1 Symptomatic relief and management of chronic (long term) intractable pain.
2 Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions.
(B) Flectrical Muscle Stimulation ( Russian and Galvanic-Interrupted ) is indicated for:
- Relaxation of Muscle spasm. 1.
- Prevention or Retardation of disuse atrophy. 2.
- Increasing local blood circulation. 3.
- Muscle re-education. 4.
Immediate post-surgical stimulation of calf muscles న్న to prevent venous thrombosis.
-
Maintaining or increasing range of motion 6.
( C) Galvanic-DC Continuous mode is indicated for:- -
Relaxation of muscle spasm. 1.
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use Over-The-Counter-Use __________ :
. OR
NISSAS
rav
(Per 21CFR 801.109)
(Optional Hormat 1-2-96)
Murani C. Provost
8.1
(Division Sign-Off) Division of General, Restorative and Neurological Devices
1993229 510(k) Number _