The model 4400 series of TENS and Microcurrent devices are indicated for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.

Device Description

The Promax® family of non-invasive nerve stimulation therapy devices are userinteractive microprocessor controlled stimulators, designed for end-user comfort, ease of use, and to assist with therapy compliance. The Promax device has combined two modalities of electrical stimulation: (TENS and Microcurrent) used in a number of legally marketed predicate devices into one device. The Promax family of devices provide low frequency, non-invasive electrical stimulating therapy used for the symptomatic relief of chronic, intractable pain and the management of pain associated with post-traumatic or post-operative conditions. Although only one modality can be operated at a time the Promax with its six available preprogrammed TENS modes and three Microcurrent modes provide a plethora of options, so the patients unique therapeutic requirements can easily be selected. The following ten preprogrammed modes are available within the Promax family: Normal, Strength Duration (SD), SMP, Burst, Rate Modulated, Width Modulated, Multi-modulated, Positive-DC Microcurrent, Biphasic Microcurrent, and Negative-DC Microcurrent.

Each mode is made of a different pattern of electrical impulses and intensity settings. The SD mode delivers the unique pattern of electrical impulses with maximum intensity of 11microColumbs. The SMP mode delivers its pattern of electrical impulses at the highest intensity level (24 microColumbs) the Promax delivers. The intensity variety is another therapeutic option directed to meet the prescribed patients therapy requirements.

Additional to the therapeutic option menu, the Promax devices provide a variety of features such as; last therapy recall, low battery notification, patient usage timers, open channel notification, as well as a self-diagnostic feature. The self-diagnostic feature is credited with notifying the user if the device requires maintenance prior to use. The many functions and features available with the Promax device-family are attributed to the size of the microprocessor. Many of these features available with the Promax are not available on other devices where the microprocessors size limitation or electrical mechanical controls are a factor. The microprocessor performance and unique operating software in the Promax provides for the pull-tables and algorithms that generate the waveforms, pulses, and duration/ time curves that are not available on other devices. One such feature is the last therapy recall protocol. This software driven feature allows the patient to resume therapy with little effort, following shut down or an open lead occurrence, (a result of poor continuity) with the same therapeutic settings. Another software driven feature is the Strength Duration Compensation protocol. This protocol starts out at zero amplitude or no stimulation to prevent patient-startling, and in a short time span based upon the Power Curve algorithm works the patient to the therapy settings without the patients experiencing uncomfortable sensations. This protocol is not available when the Promax is in the SMP mode.

Different models of the Promax family provide different therapeutic modes to support more specifically the therapist with the modes and modalities needed to implement the prescribed clinical-protocol. Only the Promax XP-4400 model will have all 10 modes serving both the TENS and Microcurrent therapy menu. The Promax TN-4410 will have the TENS modes, while the Promax MC-4440 presents the Microcurrent modes. The Promax-Libra model LBR-4420 is the basic TENS model with a Constant and Burst mode.

AI/ML Overview

Here's an analysis of the provided text regarding the Promax Family of TENS devices, focusing on acceptance criteria and study information:

Based on the provided document, there is no specific study described that establishes explicit acceptance criteria for the Promax Family of TENS devices in terms of clinical performance metrics (e.g., pain reduction percentages, patient satisfaction scores, or objective physiological changes).

Instead, the submission for the Promax Family of TENS primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. This is a common pathway for 510(k) submissions where a new device is shown to be as safe and effective as devices already on the market without requiring new clinical trials that establish novel performance criteria.

Therefore, the "acceptance criteria" for this device, as presented in the document, are implicitly met by demonstrating that its technological characteristics and indications for use are comparable to those of the predicate devices, and that it meets relevant electrical safety and performance standards.

Here's a breakdown of the requested information based on the provided text, recognizing the absence of a dedicated performance study with explicit acceptance criteria:

Acceptance Criteria and Study Information for Promax Family of TENS

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices (Safety & Effectiveness)	The Promax family of devices are of comparable type and are substantially equivalent to legally marketed predicate devices (SMP-Plus, SMP, SX, Max III, Ultrapac II SX, HMC-Home Microcurrent). Performance data for the Promax family Models XP-4400, TN-4410, TN+430, LBR-4420 and MC-4440 are substantially equivalent to the TENS and Microcurrent devices distributed under K982410, K930865 and K935132, respectively.
Compliance with Electrical Medical Standards and Safety Requirements	The devices meet the latest electrical medical standards and safety requirements, including the EN-60601 standard for electrical safety, EMC, and the Performance Standard for Electrode Lead wires and Patient Cables, CFR 898.
Delivery of Stated Therapeutic Modes/Features	The device provides various preprogrammed TENS (Normal, Strength Duration (SD), SMP, Burst, Rate Modulated, Width Modulated, Multi-modulated) and Microcurrent (Positive-DC Microcurrent, Biphasic Microcurrent, Negative-DC Microcurrent) modes, as well as features like last therapy recall, low battery notification, patient usage timers, open channel notification, and self-diagnostic.
Intensity Delivery	SD mode delivers impulses with maximum intensity of 11 microcoulombs. SMP mode delivers impulses at the highest intensity level (24 microcoulombs).

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not applicable. The document does not describe a specific clinical "test set" or performance study with a defined sample size for the Promax devices. The substantial equivalence argument relies on the established safety and effectiveness of the predicate devices.
Data Provenance: Not applicable. No new clinical data from a test set is presented.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. There is no described test set requiring expert-established ground truth.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no described test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No. The document does not describe an MRMC comparative effectiveness study where human readers (or users in this context) would be evaluated with or without AI assistance. This device is a TENS/Microcurrent stimulator, not an AI-assisted diagnostic tool.
Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was performed.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done

Standalone Performance: Not applicable in the context of an algorithm's diagnostic performance. The "standalone" performance here refers to the device's electrical output and adherence to safety standards, which is addressed by compliance with EN-60601 and CFR 898 (as noted in the table above). The device's modes and features are described, indicating its functional capabilities without human intervention beyond initial setup.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" implicitly used for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (clinical efficacy and safety data for those devices, and regulatory compliance of those devices). The Promax devices are being cleared based on their similarity to these established devices. The "ground truth" for the device's own characteristics is its adherence to technical specifications and relevant electrical standards.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This device is a hardware/firmware medical device, not a machine learning or AI model that requires a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML model.

Summary

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K02Z409

Promax Family of TENS

AUG 1 2 2002

June 20,2002

SUMMARY OF SAFETY AND EFFECTIVENESS REHABILICARE INC. PROMAX® TENS AND MICROCURRENT DEVICE MODELS XP-4400, TN-4410, LBR-4420, MC-4440

SUBMITTER INFORMATION

A.	Company name:	REHABILICARE, INC.
B.	Company Address:	Rehabilicare, Inc.1811 Old Highway 8New Brighton, MN 55112
C.	Company Phone:Company Fax:	(651) 638-0590(651) 638-0479
D.	Contact Person:	Edward F. ValdezRegulatory Affairs, Rehabilicare Inc.
E.	Date Summary Prepared:	May 13, 2002

DEVICE IDENTIFICATION

A.	Common name:	Transcutaneous electrical nerve stimulator(TENS) for pain relief
B.	Trade name:	Promax-XP TENS and Microcurrent device, Model XP-4400Promax-TENS, TENS device, Model TN-4410Promax-Libra, Basic TENS Device, Model LBR-4420Promax-MC, Microcurrent Device, Model MC-4440
C.	Classification:	Class II
D.	Product Code:	GZJ

IDENTIFICATION OF PREDICATE DEVICE

The Rehabilicare, Inc. Model 4400 series of Promax Transcutaneous Electrical Nerve Stimulator (TENS) and Microcurrent devices are of comparable type and are substantially equivalent to the following predicate devices.

Device Name	Type	Manufacturer	510(k) No.	Date Cleared
SMP-Plus,SMP, and SX	TENS	RehabilicareInc.	K982410	October 7, 1998
Max III	TENS	Stayodyn Inc.	K930865	February 17, 1993
Ultrapac II SX	TENS	RehabilicareInc.	K872657	June 25, 1987
HMC- HomeMicrocurrent	Micro-current	RehabilicareInc.	K935132	December 21, 1993

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June 20,2002

Additionally, the Promax-Libra has an external switch that allows the patient receiving the therapy to manually switch between the two modes with out the amplitude dropping to zero. This feature only available on the Promax-Libra model provides for a therapeutic option directed toward spontaneous pain episodes that appropriately is controlled manually through the discretion of the patient experiencing the painful episode.

These low frequency devices meet the latest electrical medical standards and safety requirements. including the EN-60601 standard for electrical safety. EMC and the Performance Standard for Electrode Lead wires and Patient Cables, CFR 898.

The Promax devices are lightweight, portable and designed to for ease of use. The Promax's trim, oval shape has dimensions ( 0.875 X 2.5 X 3.5 inches) that require minimal dexterity. The user can interact with the device through seven soft key buttons and a clearly visible, thirty two-character liquid crystal display (LCD) that displays the operating status and parameters.

The devices are fitted with a belt clip and a leadwire management system so the device can be attached to clothing, or concealed under clothing, and worn without excessive exposed leadwires inhibiting the patient's mobility.

All the Promax devices are provided in a kit that includes; lead wires, electrodes, and an operator's manual. Accessories such as skin care products, leadwire, electrode types and garments have been tested with the Promax devices and can be ordered to augment the standard kit. The garment-accessories are used to facilitate the ease of electrode placement, so the therapy is targeted to specific areas of the human anatomy and more beneficial to the patient. The garment-accessories are designed to assist the home user of electrical -therapy with electrode placement with little or no assistance, and are worn under normal attire.

INDICATION FOR USE

TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. The device has no curative value and should only be used in conjunction with medical supervision.

SUBSTANTIAL EQUIVALENCE

The Promax family of devices is of comparable type and is substantially equivalent to legally marketed predicate devices.

TECHNOLOGICAL CHARACTERISTICS

The Promax family of TENS and Microcurrent devices are portable, battery-powered, electronic pulse generator devices like all of the predicate devices. The microprocessorbased technology of the Promax provides options and safety features that are not available on many other predicate devices. A direct result of this technology is the availability of a dual modality device.

PERFORMANCE DATA

The performance data for the Promax family Models XP-4400, TN-4410, TN +430, LBR-4420 and MC-4440 are substantially equivalent to the TENS and Microcurrent devices distributed under K982410, K930865 and K935132, respectively.

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June 20,2002

DEVICE DESCRIPTION

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2002

Mr. Edward F. Valdez Regulatory Affairs Director Rehabilicare, Inc 1811 Old Highway 8 New Brighton, Minnesota 55112

Re: K022405

Trade/Device Name: PROMAX-XP, TENS and Microcurrent Device, Model XP-4400 PROMAX-TN, TENS Device, Model TN-4410; PROMAX-Libra, TENS Device, Model LBR-4420 PROMAX-MC, Microcurrent Device, Model MC-4440 Regulation Number: 21 CFR §882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: June 15, 2002 Received: July 16, 2002

Dear Mr. Valdez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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Page 2 - Mr. Edward F. Valdez

(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

R. Mark H. Milliman

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

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Promax Family of TENS

SPECIAL 510(k) Notification 510(k) K011017 Rehabilicare Corporation

June 20,2002 Page of

KO22405

510(k) NUMBER. (IF KNOWN):

DEVICE NAME:

PROMAX-XP, TENS and Microcurrent model XP-4400 PROMAX-TN, TENS model TN-4410 PROMAX-Libra, TENS model LBR-4420 PROMAX-MC, Microcurrent model MC-4440

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

concurrence of CDRH, Office of Device valuation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

for Mark A. Mikanen

Division of General, Restorative and Neurological Devices

510(k) Number K022405

Regulation Number and Section

§ 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).