(30 days)
Not Found
Not Found
No
The device description focuses on standard electrotherapy features and controls, with no mention of adaptive algorithms, learning capabilities, or AI/ML terminology. The "Fifteen preset therapy protocols" are fixed settings, not indicative of AI/ML.
Yes
The device is intended for "symptomatic relief and management of chronic pain," "relaxation of muscle spasm," and "increasing local blood circulation," among other therapeutic indications.
No
The device is an interferential stimulator and neuromuscular stimulator, designed for pain relief, muscle spasm relaxation, and muscle re-education. Its stated 'Intended Use / Indications for Use' and 'Device Description' focus on providing treatment rather than diagnosing conditions.
No
The device description explicitly details hardware components such as a battery system, AC wall adapter, lead wire/cable assembly, LCD display, and tactile switches, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PMD-2000 Interferential Stimulator is an electrotherapy device that applies electrical currents to the body for therapeutic purposes (pain relief, muscle stimulation). It does not analyze biological samples.
- Intended Use: The intended use clearly describes the application of electrical stimulation for pain management and muscle function, not the analysis of biological samples.
- Device Description: The description details the electrical stimulation modes, controls, and power source, with no mention of sample handling or analysis.
Therefore, the PMD-2000 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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. .
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.
Product codes (comma separated list FDA assigned to the subject device)
IPF and LiH
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.
- 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.
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
clinic, and outpatient use. Once prescribed by a physician
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)
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.
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
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: (800) 689-9892 Fax: (949) 266-5928
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.: | |||
| 10-08-002 | Process Owner: | ||
| President | Revision: | ||
| A | File name: | ||
| 10-08-002 PMD-2000 510(k) 510(k) Summary.doc |
1
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.: | |||
| 10-08-002 | Process Owner: | ||
| President | Revision: | ||
| A | File name: | ||
| 10-08-002 PMD-2000 510(k) 510(k) Summary.doc |
2
- 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.: | |||
| 10-08-002 | Process Owner: | ||
| President | Revision: | ||
| A | File name: | ||
| 10-08-002 PMD-2000 510(k) 510(k) Summary.doc |
3
- 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 |
4
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.
5
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
6
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
Page __ of ___________________________________________________________________________________________________________________________________________________________________
510(k) Number K042881