(489 days)
Not Found
No
The device description focuses on electrical stimulation parameters and hardware components, with no mention of AI or ML. The performance studies also focus on electrical characteristics and timing, not algorithmic performance.
Yes
The device is described as a "Powered Muscle Stimulator and TENS device" with intended uses directly related to treating medical conditions and symptoms, such as pain relief, muscle spasm relaxation, and prevention of disuse atrophy.
No
The intended uses provided (relaxation of muscle spasm, prevention of disuse atrophy, increasing circulation, muscle re-education, preventing venous thrombosis, and increasing range of motion, as well as symptomatic relief of chronic intractable pain) are all therapeutic or palliative in nature, not diagnostic. A diagnostic device is used to identify a disease, condition, or injury.
No
The device description explicitly details hardware components such as a battery, channels, timer, lead wire receptacles, potentiometers, and an a/c adaptor, indicating it is a physical device with electrical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are all related to treating or managing conditions within the human body (muscle stimulation, pain relief). IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a device that applies electrical stimulation to the body. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related terms: There are no mentions of analyzing samples, reagents, assays, or other terms typically associated with IVD devices.
This device falls under the category of a therapeutic device that directly interacts with the patient's body for treatment purposes.
N/A
Intended Use / Indications for Use
Powered Muscle Stimulator Device: 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 calf muscles to prevent venous thrombosis. 6-Maintaining or increasing range of motion. TENS Device: Symptomatic relief of chronic intractable pain. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The EGS4000 is a Powered Muscle Stimulator and TENS device. Ine is a small battery operated device, as its predecessor, the EGS 300. The additional operational features include a second channel, a timer, additional switching rates, a change in lead wire receptacles -- to comply with the newest proposal on lead independent intensity Additionally, attachment. -----------------------------------------------------------------------------------------------------------------------------------------------------------------wire To enhance the versatility of the potentiometers are used. predicate this unit may also operate with an a/c adaptor. For recording time elapsed in usage, a data port allows for These last two features are accessing the information. performed with all the appropriate mechanisms to ensure patient safety The waveform, intensity available and pulse rates available are all as in the predicate device. Battery operation of the EGS4000 is performed with a 9 volt battery as opposed to the This will allow the end previous special 14.4 volt battery. user greater convenience while additionally allowing longer operating time with a single battery.
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
licensed practitioner
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)
Non-Applicable
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
EXHIBIT #1 Page 1 of 3
K955666 April 15, 1997
510 (K) 8000087
This summary of 510(k) safety and effectiveness information is This Bumbly Of 310(x) Barbor and Secondance with the requirements of SMDA 1990 and 21 CFR 5807.92.
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
Submitter's Identification: 1.
S&P Electrical Industries, Inc. D/B/A Electro-Med Health Industries 11601 Biscayne Boulevard Suite 200A Miami, Florida 33181
Date Summary Propared:
December 11, 1995
Name of the Device: 2 -
EGS4000 (High Voltage Pulsed Galvanic Stimulator)
3. Predicate Device Information:
EGS 300 (Portable High Voltage Pulsed Galvanic Stimulator)
Specification Developer:
Electrical industries, Inc. D/B/A Electro-Med Health S&P Industries
510 (k) Numbers:
| • K790847 -- | Original submission- |
|---|---|
| -------------- | ---------------------- |
- Substantial equivalence established ● K802107A--Addition of TENS language and treatment of pain-Substantial equivalence established December 4, 1981 letter from Office of Compliance permitting reference to pain. ● K832371 --Dental submission-Substantial equivalence again established and labeling accepted.
1
Exhibit #1 Page 2 of 3
Device Demarintion: 4 .
The EGS4000 is a Powered Muscle Stimulator and TENS device. Ine is a small battery operated device, as its predecessor, the EGS 300. The additional operational features include a second channel, a timer, additional switching rates, a change in lead wire receptacles -- to comply with the newest proposal on lead independent intensity Additionally, attachment. -----------------------------------------------------------------------------------------------------------------------------------------------------------------wire To enhance the versatility of the potentiometers are used. predicate this unit may also operate with an a/c adaptor. For recording time elapsed in usage, a data port allows for These last two features are accessing the information. performed with all the appropriate mechanisms to ensure patient safety
The waveform, intensity available and pulse rates available are all as in the predicate device. Battery operation of the EGS4000 is performed with a 9 volt battery as opposed to the This will allow the end previous special 14.4 volt battery. user greater convenience while additionally allowing longer operating time with a single battery.
રું . Intended Use:
Powered Muscle Stimulator Device:
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 calf muscles to prevent venous thrombosis.
6-Maintaining or increasing range of motion.
TENS Device:
Symptomatic relief of chronic intractable pain.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.
Comparison to Predicate Devices: 6.
The predicate device, the EGS 300, is a battery operated "high voltage pulsed galvanic stimulator", also known as neuromuscular stimulator or monophasic pulsatile current. This device replicates the waveform, in amplitude, duration and frequencies available. The predicate device uses knobs
2
EXHIBIT #1 Page 3 of 3
This device does the (potentiometers) for patient controls. The predicate device utilizes a switch to change Same. Same. Inc. Predictive electrode, this device does the same.
The additional features on the EGS4000 are an additional output channel, a timer, a separate power On-Off switch, additional switching rates, a change in lead wire recepattachment, operation on a 9V battery as opposed to a 14.4V dedicated battery, optional a/c adaptor and an elapsed time reading mechanism.
The obvious difference is one-third the weight and less than one-half the size.
Discussion of Non-Clinical Tests Performed for Determination 7. of Substantial Equivalence are as follows:
The development has been with oscilloscope comparisons for Timing was verified with waveforms and its characteristics. well as oscilloscope comparisons. timing checks as Calculations for pulse charge, current density and power density were accomplished.
8. Discussion of clinical tests performed:
Non-Applicable
9. Conclusion:
The EGS4000 is presented for approval to meet today's changes in technology as well as newer FDA requirements for cables and lead wires. The changes and upgrades to the device meet both the FDA requirements and some market requirements. Function and output have not changed. Indications, contraindications and precautions are all updated.
S&P ELECTRICAL INDUSTRIES, INC. D/B/A ELECTRO-NED HEALTH INDUSTRIES
By: Phillip Lehman, President
By : Phyllis Lehman, President
QATE: December 11, 1995