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.

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. 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.

AI/ML Overview

This document is a 510(k) Summary for the Microstim J-1304D Electrical Muscle Stimulator. It does not contain information about acceptance criteria or a study designed to prove the device meets such criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical effectiveness or meet specific performance acceptance criteria through a dedicated study. The document primarily focuses on describing the device, its intended use, and its technical specifications, and comparing it to a legally marketed predicate device (Sys stim 226, K964028) made by Mettler Electronics Corp.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets or data provenance.
Number of experts, their qualifications, or adjudication methods for ground truth.
A multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone algorithm performance.
The type of ground truth used (beyond implying common applications for muscle stimulators).
Sample size for a training set.
How ground truth for a training set was established.

The provided text simply states that the Microstim J-1304D has the "same intended use as predicate" and is "substantially equivalent" to the predicate device, which is the basis for its 510(k) clearance.

Summary

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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 ComplexLight Industrial AreaJodhpur 342003India.
Phone :	91 - 291 - 741183
Fax :	91 - 291 - 742289
Contact Person :	Mrs. Nisha Johari
Date the Summaryis submitted :	January 5th '98.resubmitting on March 10th '98.

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Device for which clearance is required

Trade Name	:	Microstim J-1304D
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.

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SUMMARY:

KA80040

Description:- (Principle, Mode & Design)

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 :-

1. Relaxation of Muscle Spasm.
1. Prevention or retardation of disuse atrophy.
1. Increase local body circulation.
র্বা Muscle re-education.
1. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
్. Maintaining or increasing range of motion.

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510 (k) Document Number - K- 980040

KQ80040

	Technical SpecificationMicrostim 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 ohmat 2 Kohmat 10 Kohm	40 mA x 0.6 msec = 24 micro coulomb20 mA x 0.6 msec = 12 micro coulomb6 mA x 0.6 msec = 3.6 micro coulomb
Modulation OptionsAmplitude	V peak values are :-20V at 500 ohm40V at 2 Kohm60V 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 frequencyon Cyclic off "8 sec."	10 mA
Max. current densityunder 2" diameterelectrodes	1.97 mA/cm2

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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.

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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

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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)

Regulation Number and Section

§ 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).