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K Number
K960457
Device Name
ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C
Manufacturer
MED LABS, INC.
Date Cleared
1996-09-06

(220 days)

Product Code
IPF
Regulation Number
890.5850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The new versions will incorporate three changes, all of which we believe to be minor, and may be accurately described as technological improvements. 1. First, we wish to change the type of battery from a 67.5 volt to a 9 volt. 2. Second, we are changing the electrode connectors from .080" pin plugs and pin jacks to a safer design as recommended by the F.D.A.. The new connector will be a 3.5mm right angle phone plug, which is physically too large to fit into a standard 120 volt outlet. 3. The third change will add a new circuit to limit the on-time (Pulse Width) and duty cycle in the Interrupted D.C. (Galvanic) mode.
More Information

Not Found

Not Found

No
The device description focuses on hardware changes (battery, connectors, circuit) and does not mention any software or algorithmic components related to AI or ML. The "Mentions AI, DNN, or ML" section is also explicitly marked as "Not Found".

Yes
The device is described as an EMS (Electrical Muscle Stimulator) from the reference devices, designed to deliver electrical stimulation to the patient's skin and surrounding tissue, suggesting a therapeutic function.

No
Explanation: The provided text describes technological improvements related to battery, electrode connectors, and circuitry for limiting on-time in Interrupted D.C. (Galvanic) mode. It does not mention any diagnostic capabilities or intended use for diagnosing conditions.

No

The device description explicitly details changes to hardware components (battery, electrode connectors, and a new circuit), indicating it is a physical device, not software-only.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use / Indications for Use: This section is "Not Found," which is a primary indicator of the device's purpose.
  • Device Description: The description focuses on electrical and physical changes (battery, connectors, circuit for on-time/duty cycle). These are related to the device's operation and safety, not the analysis of biological samples.
  • Anatomical Site: The device is applied to the "patients skin and surrounding tissue." This suggests a direct interaction with the body, not the testing of samples taken from the body.
  • Lack of IVD-related terms: There is no mention of biological samples (blood, urine, tissue, etc.), assays, reagents, or laboratory procedures, which are characteristic of IVD devices.

The description strongly suggests this is a device that delivers electrical stimulation to the skin, likely for therapeutic or diagnostic purposes applied directly to the patient. This aligns with the mention of "Interrupted D.C. (Galvanic) mode" and the anatomical site.

N/A

Intended Use / Indications for Use

Not Found

Product codes

Not Found

Device Description

The new versions will incorporate three changes, all of which we believe to be minor, and may be accurately described as technological improvements.

    1. First, we wish to change the type of battery from a 67.5 volt to a 9 volt. This will make battery replacement much easier and much less expensive for our customers. Initially, several companies made the 67.5 volt battery, but now, it is only available from Eveready. In addition, Eveready has recently increased the price of this battery by about 80%. It is now more cost-effective to use a D.C. to D.C. Converter powered by an inexpensive and readily available 9 volt battery.
      This change is for the convenience of our customers, and will not have any effect on the specifications, safety, or efficacy.
    1. Second, we are changing the electrode connectors from .080" pin plugs and pin jacks to a safer design as recommended by the F.D.A.. The new connector will be a 3.5mm right angle phone plug, which is physically too large to fit into a standard 120 volt outlet. In an F.D.A. letter from Susan Alpert, M.D., Ph.D., Director, Office of Device Evaluation, dated February 15, 1995, manufacturers were told that it is not necessary to wait for 510(k) approval before making this change. However, we should notify the F.D.A. when we make the change.
    1. The third change will add a new circuit to limit the on-time (Pulse Width) and duty cycle in the Interrupted D.C. (Galvanic) mode. This will prevent a user from exceeding the recommended ontime. This in turn, will limit the RMS current and power dissipated in the patients skin and surrounding tissue, and therefore keep the skin irritation to a minimum.

This change will also have no efficacy, since it will simply prevent the user from delivering a wider pulse than is recommended in the current instructions. It will, however, improve safety and comfort.

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

Not Found

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.

Not Found

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

MED LABS, INC

28 Vereda Cordillera, Goleta, California 93117

510 (k) SUMMARY: EMS-1C / EMS-2C

JANUARY 22, 1996

K960457

Contact Person: Philip D. Norvell, Chief Engineer

SEP - 6 1996

  • · Proprietary Names: EMS-1C and EMS-2C
  • · Common Name: Electrical Muscle/Neuromuscular Stimulator
  • · Classification Name: Stimulator, Muscle, Powered

Background: The EMS-2A is capable of both Interrupted Direct Current and Pulsed stimulation. The EMS-1A is identical, except that it is only capable of Interrupted D.C. stimulation. Both models have been marketed by Med Labs, since 1969. We are planning the release of two new versions of these instruments, at as early a date as possible. The new versions will be called the EMS-1C and the EMS-2C.

Description: The new versions will incorporate three changes, all of which we believe to be minor, and may be accurately described as technological improvements.

    1. First, we wish to change the type of battery from a 67.5 volt to a 9 volt. This will make battery replacement much easier and much less expensive for our customers. Initially, several companies made the 67.5 volt battery, but now, it is only available from Eveready. In addition, Eveready has recently increased the price of this battery by about 80%. It is now more cost-effective to use a D.C. to D.C. Converter powered by an inexpensive and readily available 9 volt battery.
      This change is for the convenience of our customers, and will not have any effect on the specifications, safety, or efficacy.
    1. Second, we are changing the electrode connectors from .080" pin plugs and pin jacks to a safer design as recommended by the F.D.A.. The new connector will be a 3.5mm right angle phone plug, which is physically too large to fit into a standard 120 volt outlet. In an F.D.A. letter from Susan Alpert, M.D., Ph.D., Director, Office of Device Evaluation, dated February 15, 1995, manufacturers were told that it is not necessary to wait for 510(k) approval before making this change. However, we should notify the F.D.A. when we make the change.
    1. The third change will add a new circuit to limit the on-time (Pulse Width) and duty cycle in the Interrupted D.C. (Galvanic) mode. This will prevent a user from exceeding the recommended ontime. This in turn, will limit the RMS current and power dissipated in the patients skin and surrounding tissue, and therefore keep the skin irritation to a minimum.

This change will also have no efficacy, since it will simply prevent the user from delivering a wider pulse than is recommended in the current instructions. It will, however, improve safety and comfort.

NOTE: With the EMS-1A and EMS-2A, the pulse width and duty cycle in the Interrupted D.C. mode are manually controlled (by how long the user presses the switch). Our current instruction manual states that the push-button switch should be pressed for about 1/4 second.

1

510 (k) SUMMARY: EMS-1C / EMS-2C

Substantial Equivalence: These units are substantially equivalent in efficacy and safety to the Powered Muscle Stimulators which MED LABS, Inc. currently markets, since they are based on the same equipment, specifications, indications, and contraindications, with improved technology.

COMPANY MED LABS, Inc. MED LABS, Inc. PRODUCT EMS-1/EMS-1A EMS-2/EMS-2A

510K NUMBER "Grandfathered"

"Grandfathered"

NOTES Pre-amendment Device Pre-amendment Device

We request that the EMS-1C be accepted as equal in safety and effectiveness to the above equipment.

If you have any questions or require further documentation, please feel free to call us at (805) 968-2486.