(189 days)
Not Found
No
The device description details a microprocessor-based electrical muscle stimulator with preset parameters and user-selectable options for frequency, time, and off-time. There is no mention of learning, adaptation, or complex data analysis that would indicate AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is an Electrical Muscle Stimulator intended for therapeutic applications such as relaxation of muscle spasm, prevention of disuse atrophy, and increasing range of motion.
No
The device is an Electrical Muscle Stimulator used for therapeutic purposes such as muscle relaxation, atrophy prevention, circulation increase, and muscle re-education. It does not perform any diagnostic functions.
No
The device description explicitly states it is an "electrotherapy unit" and describes physical components like a microprocessor-based circuit, membrane panel, display window, lead wires, electrode wires, and self-adhesive electrodes. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the Microstim J 1304D is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as an Electrical Muscle Stimulator used for therapeutic purposes on the human body (relaxation of muscle spasm, prevention of atrophy, increasing circulation, muscle re-education, preventing venous thrombosis, maintaining range of motion). These are all in vivo applications, meaning they are performed on a living organism.
- Device Description: The description details an electrotherapy unit that delivers electrical pulses to stimulate muscles. This is consistent with an in vivo treatment device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. The Microstim J 1304D operates in vivo to directly stimulate muscles.
N/A
Intended Use / Indications for Use
Microstim J 1304D is an Electrical Muscle Stimulator to be used by Physiotherapy or clinicians in Physical Medicine for following applications :-
-
- Relaxation of Muscle Spasm.
-
- Prevention or retardation of disuse atrophy.
-
- Increase local body circulation.
- Muscle re-education.
-
- Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
- Maintaining or increasing range of motion.
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
Microstim J-1304D is an electrotherapy unit used for electrical Muscle Stimulator This microprocessor based circuit generates biphasic square pulse, with enhanced accuracy and dependability. The pulse duration is preset to most effectively stimulate motor fibers. The waveforms are delivered in an envelope of trapezium shaped impulse. The stimulation is more effective yet being smooth and comfortable.
Such Muscle Stimulation has traditionally been used to prevent disuse atrophy in patients unable to exercise their own muscles because of debilitating or traumatic injury. Muscle Stimulation is also considered appropriate for range of motion exercises, reducing spasm, increasing blood flow, muscle re-education and or to prevent venous thrombosis.
J-1304D provides such treatment to four patients simultaneously. Each channel separately has power increase and start/stop key. The increase in intensity by touch button key on membrane panel gives very smooth rise. It delivers exact amount of current that can be visualized as % power in display window. There are four frequency parameters to choose from 200,300,600 and 800 Hz. The treatment time can be selected from 15,30,45 and 60 min.Cyclic 'off' time at 0 gives advantage of reaching the maximum tolerance level or desired level of intensity and then selection from 2 sec.4 sec. and 8 sec 'off' time for kind of treatment.
The design of Microstim J-1304D, as having slanted front panel, is for the ease of use to the clinician. Made of aluminum it is strong and sturdy.
The unit is supplied with lead wire, four electrode wires and four sets of self adhesive electrodes.
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
Physiotherapy or clinicians in Physical Medicine
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
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Jul 1 3 1998
Misha Communication Industries EC-3, Electronics Complex, Light Industrial Area, JODHPUR-342 003 (India) Fax : (0291)742289 Phone : ( 0291 ) 7 4 1 1 8 3 (F), 3 0 0 2 8 (R)
12980040
" 510 (k) Summary"
| Submitter's name : | Nisha Communication Industries |
|---|---|
| Address : | EC 3, Electronic Complex |
| Light Industrial Area | |
| Jodhpur 342003 | |
| India. | |
| Phone : | 91 - 291 - 741183 |
| Fax : | 91 - 291 - 742289 |
| Contact Person : | Mrs. Nisha Johari |
| Date the Summary | |
| is submitted : | January 5th '98. |
| resubmitting on March 10th '98. |
1
Device for which clearance is required
| Trade Name | : | Microstim J-1304D | K980040 |
|---|---|---|---|
| Common Name | : | Electrical Muscle Stimulator | |
| Classification Name | : | Physical Medicine (Per 21 CFR Section 890-5850) | |
| Legally Marketed Device | |||
| Sys stim 226 | : | Muscle Stimulator 510(k) number- K964028. | |
| Manufacturer | : | Mettler Electronics Corp. | |
| Address | : | 1333 S. Claudia St. Anaheim Ca. 92805 | |
| Tel. | : | 001 (714) 533 2221 |
Microstim J 1304D has same intended use as predicate. Both the muscle where are to be used in Physical Medicine by Clinicians and Therapists.
2
SUMMARY:
KA80040
Description:- (Principle, Mode & Design)
Microstim J-1304D is an electrotherapy unit used for electrical Muscle Stimulator This microprocessor based circuit generates biphasic square pulse, with enhanced accuracy and dependability. The pulse duration is preset to most effectively stimulate motor fibers. The waveforms are delivered in an envelope of trapezium shaped impulse. The stimulation is more effective yet being smooth and comfortable.
Such Muscle Stimulation has traditionally been used to prevent disuse atrophy in patients unable to exercise their own muscles because of debilitating or traumatic injury. Muscle Stimulation is also considered appropriate for range of motion exercises, reducing spasm, increasing blood flow, muscle re-education and or to prevent venous thrombosis.
J-1304D provides such treatment to four patients simultaneously. Each channel separately has power increase and start/stop key. The increase in intensity by touch button key on membrane panel gives very smooth rise. It delivers exact amount of current that can be visualized as % power in display window. There are four frequency parameters to choose from 200,300,600 and 800 Hz. The treatment time can be selected from 15,30,45 and 60 min.Cyclic 'off' time at 0 gives advantage of reaching the maximum tolerance level or desired level of intensity and then selection from 2 sec.4 sec. and 8 sec 'off' time for kind of treatment.
The design of Microstim J-1304D, as having slanted front panel, is for the ease of use to the clinician. Made of aluminum it is strong and sturdy.
The unit is supplied with lead wire, four electrode wires and four sets of self adhesive electrodes.
Electrodes are legally marketed in US Conmed Corporation mfr. by: -310. Broad street. at Utica NY. 13501 U.S.A
Intended Use
Microstim J 1304D is an Electrical Muscle Stimulator to be used by Physiotherapy or clinicians in Physical Medicine for following applications :-
-
- Relaxation of Muscle Spasm.
-
- Prevention or retardation of disuse atrophy.
-
- Increase local body circulation.
- র্বা Muscle re-education.
-
- Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
- ్. Maintaining or increasing range of motion.
3
510 (k) Document Number - K- 980040
KQ80040
| | Technical Specification
Microstim J - 1304 D |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Power Source | 110V AC +/- 10% 50 Hz - 60 Hz |
| Number of output modes : | |
| Channels | Four |
| Synchronous | Yes |
| Max. output current | 40 mA Peak at 500 Ohm (+/- 5%) |
| Max. output voltage | 60 V Peak at 10 Kohm (+/- 5%) |
| Channel isolation | Yes (conforms to ANSI NS4 sec. 3.2.3.2. 1985) |
| Waveform | Biphasic |
| Current Density | 1.97mA / Sq. cm (under 2 inches diameter electrodes) |
| Power Density | 39.47 mW / Sq. cm (under 2 inches diameter electrodes) |
| Max. Phase charge | |
| at 500 ohm
at 2 Kohm
at 10 Kohm | 40 mA x 0.6 msec = 24 micro coulomb
20 mA x 0.6 msec = 12 micro coulomb
6 mA x 0.6 msec = 3.6 micro coulomb |
| Modulation Options
Amplitude | V peak values are :-
20V at 500 ohm
40V at 2 Kohm
60V at 10 Kohm |
| Frequency | Selected from 200, 300, 600, 800 PPS. |
| Mechanical Specification | Weight :- 8.8 lb.
Size : - 17"(l) X 13"(b) X 6"(w) |
| Pulse width | 0.6 msec. |
| Amp. Modulation options | 2 sec and 4 sec - 8sec off time |
| Avg. current at max.
intensity and frequency
on Cyclic off "8 sec." | 10 mA |
| Max. current density
under 2" diameter
electrodes | 1.97 mA/cm2 |
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with flowing lines, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 1998
Mrs. Nisha Johari ·c/o Mrs. Reena Daga Nisha Communication Industries Canyon Creek Apartment J-146 10201 Lindley Avenue 91325 Northridge, California
K980040 Re: Electronic Muscle Stimulator - Microstim J-1304D Regulatory Class: II Product Code: IPF Dated: June 25, 1998 Received: June 30, 1998
Dear Mrs. Johari:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಕ 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 comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.
5
Page 2 - Mrs. Nisha Johari
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 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 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
Ph.D., M.D. M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K980040
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
(1) Relaxation of Muscle Spasm.
- (2) Prevention or retardation of disuse atrophy.
- (3) Increasing local blood circulation.
- (4) Muscle re-education.
- (5) Immediate postsurgical stimulation of calt muscles
to provent v to prevent venous thrombosis. - (6) Maintaining or increasing range of motion.
(PLEASE DO NOT WRITE BBLOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K980040
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)