PMD-2000 INTERFERENTIAL STIMULATOR

K042881 · Phoenix Medical Devices, LLC · IPF · Nov 18, 2004 · Physical Medicine

Device Facts

• Record ID: K042881
• Device Name: PMD-2000 INTERFERENTIAL STIMULATOR
• Applicant: Phoenix Medical Devices, LLC
• Product Code: IPF · Physical Medicine
• Decision Date: Nov 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The PMD-2000 Interferential Stimulator is a multifunction device intended to be used for muscle and nerve stimulation using either of its two therapy modes. Interferential Current Stimulation or Neuromuscular Electrical Stimulation. In the Interferential Current Mode the PMD-2000 is indicated for the following conditions: . Symptomatic relief of acute pain . Symptomatic management and relief of chronic pain . Adjunctive treatment for the management of post traumatic and . Post-surgical pain In the Neuromuscular Stimulation Mode, the PMD-2000 is indicated for the following conditions: . Relaxation of muscle spasms: . Prevention or retardation of disuse atrophy: Increasing local blood circulation; . Muscle re-education: Immediate post surgical stimulation of calf muscles to prevent venous thrombosis; o and . Maintaining or increasing range of motion. .

Device Story

PMD-2000 is a battery or AC-powered electrical muscle and nerve stimulator for clinic and outpatient use. Following physician prescription, clinician or patient selects from 15 preset therapy protocols or adjusts amplitude, frequency, and sweep/ramp times via tactile switches and 16-character LCD. Device delivers interferential current or neuromuscular stimulation through two independent channels using color-coded lead wires. Features include pause/resume functionality and timed sessions. Software and hardware monitor energy levels at multiple checkpoints to ensure patient safety. Device provides therapeutic electrostimulation to manage pain, improve circulation, and support muscle rehabilitation. Improvements over predicate include simplified battery system (AA alkaline/NiCad/NiMH), reduced weight, and enhanced user interface.

Clinical Evidence

Bench testing only. Performance characteristics and therapy output were compared between the PMD-2000 and the predicate device to demonstrate substantial equivalence.

Technological Characteristics

Battery (AA alkaline, NiCad, NiMH) or AC adapter powered. Two independent stimulation channels. 16-character (8x2) LCD interface with tactile switches. Features include continuous/pulsed stimulation, adjustable amplitude/frequency, and sweep/ramp settings. Software-controlled safety checkpoints for energy output. Form factor designed for portability.

Indications for Use

Indicated for patients requiring symptomatic relief of acute, chronic, post-traumatic, or post-surgical pain (Interferential Current Mode) or for muscle spasm relaxation, prevention of disuse atrophy, increased local blood circulation, muscle re-education, prevention of venous thrombosis via calf stimulation, and maintenance/increase of range of motion (Neuromuscular Stimulation Mode).

Regulatory Classification

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.

Predicate Devices

• CS3101 Interferential Stimulator

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Phoenix Medical Devices. The logo features a stylized phoenix bird with its wings spread wide, positioned above the company name. The text "PHOENIX" is in a larger, serif font, while "MEDICAL DEVICES" is in a smaller font below it.

NOV 1 8 2004

# 510(k) Summary for the PMD-2000 Interferential Stimulator

### 1. Sponsor

Phoenix Medical Devices, LLC 620 Newport Center Drive, Suite 1100 Newport Beach, Ca 92660

Registration Number: 3004620982

Contact Person: Jim Klett Telephone: [phone] Fax: [phone]

Date Prepared: September 15, 2004

#### 2. Device Name

Proprietary Name: PMD-2000 Interferential Stimulator Common/Usual Name: Electrical Muscle and Nerve Stimulator Classification Names: Interferential Current Stimulator, Powered Muscle Stimulator Classification Panel: Physical Medicine Panel/Product Code: 890.5850 / IPF and LiH

### 3. Legally Marketed Device to Which Equivalence is Claimed

Proprietary Name: CS3101 Interferential Stimulator Common/Usual Name: Electrical Muscle and Nerve Stimulator Classification Names: Interferential Current Stimulator, Powered Muscle Stimulator Classification Panel: Physical Medicine Panel/Product Code: 890.5850 / IPE

| Phoenix Medical Devices, LLC | | PMD-2000 510(k) Summary | |
|------------------------------|-----------------------------|-------------------------|------------------------------------------------------------|
| Document No.:<br>10-08-002 | Process Owner:<br>President | Revision:<br>A | File name:<br>10-08-002 PMD-2000 510(k) 510(k) Summary.doc |

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K042 881

### 4. Intended Use

The PMD-2000 Interferential Stimulator is a multifunction device intended to be used for muscle and nerve stimulation using either of its two therapy modes. Interferential Current Stimulation or Neuromuscular Electrical Stimulation.

In the Interferential Current Mode the PMD-2000 is indicated for the following conditions:

- . Symptomatic relief of acute pain
- t Symptomatic management and relief of chronic pain
- Adjunctive treatment for the management of post traumatic and . Post-surgical pain

In the Neuromuscular Stimulation Mode, the PMD-2000 is indicated for the following conditions:

- . Relaxation of muscle spasms:
- . Prevention or retardation of disuse atrophy:
- Increasing local blood circulation;
- . Muscle re-education:
- Immediate post surgical stimulation of calf muscles to prevent venous thrombosis; o

and

- Maintaining or increasing range of motion. .
#### 5_ Device Description

The PMD-2000 Interferential Stimulator is a battery or AC wall adapter powered device intended for clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The PMD-2000 is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The PMD-2000 incorporates the following features:

- Two independent stimulation channels, which provide true interferential current and . neuromuscular stimulation.

| Phoenix Medical Devices, LLC | | PMD-2000 510(k) Summary | |
|------------------------------|-----------------------------|-------------------------|------------------------------------------------------------|
| Document No.:<br>10-08-002 | Process Owner:<br>President | Revision:<br>A | File name:<br>10-08-002 PMD-2000 510(k) 510(k) Summary.doc |

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- Continuous or pulsed stimulation. Various sweep and ramp times.
- Adjustable amplitude and frequency .
- . Fifteen preset therapy protocols
- . Pause button to allow temporary suspension of treatment and a resume button to allow the resumption of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes its countdown and the amplitude (intensity) is reset to zero.
- Easy to connect, easy to handle, patient lead wire/cable assembly with a "one way" . connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes.
- Timed therapy sessions. .
- . Double A (AA) battery system accommodates standard alkaline, NiCad and Nickel Metal Hydride batteries.
- The PMD-2000 user interface incorporates a 16 character (8x2) Liquid Crystal . Display (LCD) and tactile switches for menu navigation.

#### 6. Basis for Substantial Equivalence

The PMD-2000 is substantially equivalent to the legally marketed device and is similar in design, features and function and provides the intended therapy in a safe and effective manner. Both devices offer near-identical preprogrammed treatment protocols and the clinician or patient can choose one or more of these pre-set options.

Bench testing was performed on the marketed device and the PMD-2000 and the therapy output and performance characteristics for both units was substantially equivalent.

## 7. Differences Between the Marketed Device and the PMD-2000

The PMD-2000 incorporates several improvements over the legally marketed device, including:

- Simplified battery system. There is no need to exclusively use rechargeable AA . batteries. This provides great freedom of mobility and battery choice to the user. This feature greatly reduces therapy down time. The simplified battery system also lowers the weight of the device by 50% and results in a more economically priced device.
- Very low operating temperatures due to the removal of the battery charging system. .

| Phoenix Medical Devices, LLC | | PMD-2000 510(k) Summary | |
|------------------------------|-----------------------------|-------------------------|------------------------------------------------------------|
| Document No.:<br>10-08-002 | Process Owner:<br>President | Revision:<br>A | File name:<br>10-08-002 PMD-2000 510(k) 510(k) Summary.doc |

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- Improved safety due to the device software and hardware working together at . several "checkpoints" to protect the patient from unsafe energy levels.
- Greatly simplified user interface with a minimum number of steps to begin therapy . treatment.
- Easy to read interface screens of available options and settings. .
- Large "Pause" and "Stop" buttons on the interface ensure quick suspension of . treatment.

| Phoenix Medical Devices, LLC | | PMD-2000 510(k) Summary | |
|------------------------------|-----------|-------------------------|----------------------------------------------|
| Document No.: | 10-08-002 | Process Owner: | President |
| Revision: | A | File name: | 10-08-002 PMD-2000 510(k) 510(k) Summary.doc |

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2004

Phoenix Medical Devices, LLC c/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue S.E. Grand Rapids, Michigan 49548

Re: K042881

Trade/Device Name: PMD-2000 Interferential Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: November 3, 2004 Received: November 5, 2004

Dear Mr. Devine:

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

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Page 2 - Mr. Ned E. Devine, Jr.

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark A. Mckesson
B. Sc., M. Witts., Ph.D., M.D.

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

Enclosure

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# Indications for Use

510(k) Number (if known): K04288)

Device Name: PMD-2000 Interferential Stimulator

Indications for Use:

Interferential Current Mode: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post surgical and post traumatic pain.

Neuromuscular Stimulator Mode: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post surgical stimulation of calf muscles to prevent venous thrombosis.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. Mark A. Millhurn

Division of General, Restorative
and Neurological Devices

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510(k) Number K042881