(253 days)
No
The device description details a purely electromechanical system with manual controls for intensity and frequency. There is no mention of adaptive algorithms, data processing for decision making, or any other characteristics indicative of AI/ML.
Yes.
The device is intended to provide Airway Clearance Therapy and promote bronchial drainage, which are therapeutic actions.
No
The device is an airway clearance system intended for therapy and promoting bronchial drainage, not for diagnosing medical conditions.
No
The device description explicitly details hardware components including a Control Box, Power Head, Carrying Case, and Optional Self-Administrator® Strap. It also describes an electromechanical operating mechanism.
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 Electro Flo® 6 Airway Clearance System is a mechanical device that uses high-frequency chest wall oscillation to help patients clear mucus from their airways. It works externally on the body and does not involve testing biological samples.
- Intended Use: The intended use clearly states it's for "Airway Clearance Therapy and promote bronchial drainage," which is a physical therapy, not a diagnostic test.
Therefore, the Electro Flo® 6 Airway Clearance System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Electro Flo® 6 Airway Clearance System is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.
Product codes
BYI
Device Description
The Electro Flo® 6 Airway Clearance System is a High Frequency Chest Wall Oscillation System (HFCWO), including all accessories and supplies.
Electro Flo® 6 Airway Clearance System comprises:
- An electrically powered Control Box with a power switch on the back and two knobs on the front: one knob provides five intensity settings, and the other provides six frequency settings,
- The Power Head, connected by a cable to the Control Box,
- The Carrying Case,
- The Information Manual,
- The Optional Self-Administrator® Strap that can hold the Electro Flo® 6 system Power Head and enable a patient to apply therapy to the back, unassisted.
The Electro Flo® 6 Airway Clearance System's operating mechanism is an electromechanical "hammer and anvil"; the hammer is the handheld body of the Power Head, and the anvil is the surface of the Power Head that is held in contact with the chest. Repeated electrical pulses from the Control Box separate the hammer and anvil. The Frequency knob of the Control Box controls the repetition rate, and the Power knob controls the pulse duration; there are 30 combinations.
When each electrical pulse ends, the force applied by the therapist's hand forces the hammer through the gap until it strikes the anvil and delivers a mechanical impulse to the chest. The resulting pressure wave radiates into the chest cavity to shake mucus loose. Because the energy transmitted to the chest vibrations is a multiple of the force applied by hand, the Electro Flo® 6 system acts as a "force multiplier" that provides the therapist with additional control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thorax
Indicated Patient Age Range
patients weighing at least 23 Kg
Intended User / Care Setting
Home or institutional use by patients
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 Data:
Med Systems. Inc. contracted with Aeromethod Precision Engineering and Manufacturing, San Diego, CA, to conduct testing to characterize the Electro Flo® 6 system's mechanical performance. The test objectives were to verify and document that the Electro Flo® 6 system can be described as a high frequency chest wall oscillator (HFCWO) and to demonstrate that the output can be controlled by the force applied by the user to the device, as expected from its force multiplier design principle.
The test assembly was designed to collect one-dimensional vibration data along the axis of the Power Head. The Power Head body was rigidly attached to a linear bearing that could slide along a linear guide track. An elastic material pressed on the Power Head created a Static Load to simulate hand pressure. The Power Head's anvil end was attached to a plastic cvlinder in contact with a load cell that measured the waveforms at a sampling rate of 1000 Hz over a one-second interval. Waveforms were collected at a full factorial sampling with three frequency settings (1,3,6) on the Control Box, three power settings (1,3,5) on the Control Box, and three static loads of one, three, and five pounds of force applied to the Power Head. BioMedical Strategies, White River Junction, VT computed power spectra of the waveforms in arbitrary power units.
Results:
At all settings, most of the power generated by the Electro Flo® 6 system was in the acoustic frequency range of 16 - 127 Hz. Varying the static load could control the power output, as predicted by the force multiplier design principle.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5665 Powered percussor.
(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 12, 2021
Med Systems, Inc. % Frederick Cahn Principal BioMedical Strategies 133 Colonial Dr. White River Junction, Vermont 05001
Re: K201490
Trade/Device Name: Electro Flo® 6 Airway Clearance System Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: Class II Product Code: BYI Dated: August 26, 2020 Received: September 8, 2020
Dear Frederick Cahn:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brandon L. Blakely, Ph.D. Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201490
Device Name
Electro Flo® 6 Airway Clearance
Indications for Use (Describe)
The Electro Flo® 6 Airway Clearance System is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.
The device is intended for home or institutional use by patients weighing at least 23 Kg.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ----------------------------------------------- |
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3
- I. SUBMITTER: Med Systems, Inc. 2631 Ariane Drive San Diego, CA 92117
Contact: Susan B. Davis, CEO (858) 483-9671
II. Electro Flo® 6 Airway Clearance System (K201490) DEVICE: Classification Code: BYI, "Percussor, Powered-Electric" Regulation 21 CFR 868.5665, "Powered Percussor" Class II
III. PREDICATE DEVICES
Primary Predicate: Monarch Airway Clearance System (K173603) Classification Code: BYI, "Percussor, Powered-Electric" Regulation 21 CFR 868.5665, "Powered Percussor" Class II
Reference Predicate: Med Systems Electro Flo Percussor Model 5000 (K031876) Classification Code: BYI, "Percussor, Powered-Electric" Regulation 21 CFR 868.5665, "Powered Percussor" Class II
- IV. DATE February 11, 2021
V. DESCRIPTION
Device Identification
The Electro Flo® 6 Airway Clearance System is a High Frequency Chest Wall Oscillation System (HFCWO), including all accessories and supplies.
Electro Flo® 6 Airway Clearance System comprises:
- An electrically powered Control Box with a power switch on the back and two knobs on the front: one knob provides five intensity settings, and the other provides six frequency settings,
- The Power Head, connected by a cable to the Control Box, ●
- The Carrying Case,
- The Information Manual, ●
4
- The Optional Self-Administrator® Strap that can hold the Electro Flo® 6 system Power Head and enable a patient to apply therapy to the back, unassisted.
Device Characteristics and Environment of Use
The Electro Flo® 6 Airway Clearance System is durable medical equipment for home use. It is non-sterile and has no software or patient-contacting materials. Treatment sessions can last up to 20 minutes.
Device Description
The Electro Flo® 6 Airway Clearance System's operating mechanism is an electromechanical "hammer and anvil"; the hammer is the handheld body of the Power Head, and the anvil is the surface of the Power Head that is held in contact with the chest. Repeated electrical pulses from the Control Box separate the hammer and anvil. The Frequency knob of the Control Box controls the repetition rate, and the Power knob controls the pulse duration; there are 30 combinations.
When each electrical pulse ends, the force applied by the therapist's hand forces the hammer through the gap until it strikes the anvil and delivers a mechanical impulse to the chest. The resulting pressure wave radiates into the chest cavity to shake mucus loose. Because the energy transmitted to the chest vibrations is a multiple of the force applied by hand, the Electro Flo® 6 system acts as a "force multiplier" that provides the therapist with additional control.
VI. INTENDED USE
The Electro Flo® 6 System is designed for home or institutional use and provides HFCWO with controllable frequency and intensity similar to the hand percussion therapy provided by a therapist. The chest vibrations target and loosen thick, sticky mucus in the lungs so that the patient can clear it by huffing, coughing, or suction. The Electro Flo® 6 system has advantages over hand percussion because patients can administer therapy without assistance, because it does not suffer fatigue, and because it can operate at higher frequencies and force than a human therapist.
INDICATIONS FOR USE VII.
The Electro Flo® 6 Airway Clearance System is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging. The device is intended for home or institutional use for patients weighing at least 23 Kg.
VIII. CONTRAINDICATIONS
The Electro Flo® 6 system is not intended for the following classes of patients:
- Infants or children weighing less than 50 pounds (23 Kg). ●
- Patients with pacemakers or other implanted medical devices in or near the ● chest.
5
- . Patients with brittle bones, broken ribs or severe osteoporosis, severe calcium deficiencies, or severe osteoporosis.
- Patients with collapsed lungs, pulmonary embolism, lung abscess, or ● tuberculosis.
- Patients with angina, arrhythmia, aneurism in the head, neck, chest, or abdomen. ●
- Patients with severe asthma. ●
- Patients with injuries to the chest wall, spine, head, or neck that could be ● exacerbated by strong vibrations.
WARNINGS AND PRECAUTIONS IX.
WARNING - To avoid the risk of electrocution, fire, or serious injuries:
- Keep the Electro Flo® 6 system out of the reach of children. ●
- Do not use the Electro Flo® 6 system with, near, or in water. ●
- Do not use the Electro Flo® 6 system near flammable vapors or fire. ●
- Do not insert any object into any opening on the Electro Flo® 6 system.
- Inspect the Control Box and Power Head before use. Do not use the Electro ● Flo® 6 system if there is damage to the power cord or any other part of the device.
WARNING - Do not use the Electro Flo 6 while you are experiencing conditions such as:
- Recent heart attack.
- Recent surgery to the chest, abdomen, head, or neck. ●
- Bleeding from the lungs or coughing up blood. ●
- Open wounds or burns.
- Vomiting.
- . Pressure in the skull.
- Intense pain. ●
- Active hemorrhage.
- Acute asthma.
CAUTION
- The Electro Flo® 6 system is available by prescription only and is intended . solely for the person for whom it was prescribed and only for the prescribed use.
- . Users should always observe all contraindications, warnings, and cautions listed in the Information Manual.
- Do not use the Electro Flo® 6 system directly after eating. ●
- Do not percuss over bare skin. ●
- Do not percuss directly on the shoulder blade, collar bone, spine, breastbone (sternum), or breasts.
- Percussion should not hurt. If it does, STOP. Reduce the hand pressure on the ● Power Head's rear cover or reduce the power setting on the Control Box.
- Do not place Self-Administrator® strap over the head or around the neck.
6
NOTICES
To avoid damage or excessive wear:
- Do not unplug or switch off the unit until the cool-down is complete. ●
- Do not block the fan vent with hand or fingers.
- . Limit percussion to 20 minutes maximum per session to avoid overheating the system.
- Avoid using the unit in a dusty environment or laying the device on a blanket or ● carpet as lint may be drawn in by the fan and damage the unit.
- . Do not spray disinfectant on the Control Box and device; fluid could enter the device and damage the system.
- If any interferences from a television, computer, cell phone, or other electronic ● device are experienced when using the Electro Flo® 6 system, move the Electro Flo® 6 system to another room or location or turn off the interfering device.
COMPARISONS WITH THE PREDICATE DEVICES X.
Comparison with Primary Predicate
We compare the Electro Flo® 6 Airway Clearance System to a legally marketed predicate device: The Monarch Airway Clearance System (K173603). The predicate Monarch Airway Clearance System is classified in product code BYI, "Percussor, Powered-Electric", classification 868.5665, "Powered Percussor." The devices have identical indication statements.
Comparison of Indication Statements
| Electro Flo® 6 Airway | Monarch Airway | Commentary |
|---|---|---|
| Clearance System | Clearance System | |
| The Electro Flo® 6 Airway Clearance | ||
| System is intended to provide Airway | ||
| Clearance Therapy and promote bronchial | ||
| drainage where external manipulation of the | ||
| thorax is the physician's choice of | ||
| treatment. It is indicated for patients having | ||
| difficulty with secretion clearance, or the | ||
| presence of atelectasis caused by mucus | ||
| plugging. | The Monarch product is intended to | |
| provide Airway Clearance Therapy | ||
| and promote bronchial drainage where | ||
| external manipulation of the thorax is | ||
| the physician's choice of treatment. It | ||
| is indicated for patients having | ||
| difficulty with secretion clearance, or | ||
| the presence of atelectasis caused by | ||
| mucus plugging. | The indications | |
| statements are | ||
| identical. |
The devices are both electromechanical devices intended for airway clearance and have substantially equivalent technology, as shown in the following table:
7
| Characteristic | Electro Flo® 6 Airway
Clearance System | Monarch Airway
Clearance System | Commentary |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanism | Variable frequency
electromechanical
actuators. | Variable frequency
electromechanical
actuators. | Substantially equivalent:
both vibrate the chest. |
| Anatomic
positions of the
actuator(s) on the
thorax | Determined by the
therapist or patient
manually or aided by a
repositionable fabric self-
administrator strap. | Determined by the eight
pockets at fixed anatomic
locations in a fabric vest. | Substantially equivalent:
The Electro Flo® 6 system
can be positioned at the
same anatomic locations as
the Monarch System's
actuators, but it is not
limited to those positions. |
| Actuator motion | The electromechanical
actuator of the Electro
Flo® 6 system provides a
vibratory, shaking motion
to the body. | The electromechanical
actuator of the Monarch
system provides a
vibratory, shaking motion
to the body. | Substantially equivalent: |
| Type of device | Durable medical
equipment for home use. | Durable medical
equipment for home use. | Substantially equivalent. |
| Controller
Frequency range | 5 — 25 Hz | 5-20 Hz | Substantially equivalent. |
| Power supply | 120 V, 60 Hz AC | Rechargeable battery. | Substantially equivalent.
Both devices are electrically
powered |
| Weight | 1.5 Kg (Power Head) | 6 Kg (vest) | The lighter weight of the
Electro Flo® 6 system
enables it to be easily
handheld. The Monarch vest
system is worn on the body,
making the higher weight
easily tolerated. |
Comparison of Technical Characteristics
Comparison with Reference Predicate
We compare the Electro Flo® 6 Airway Clearance System our previously cleared device: The Electro Flo Percussor Model 5000 (K021876). The Electro Flo Percussor Model 5000 is also classified in product code BYI, "Percussor, Powered-Electric", classification 868.5665, "Powered Percussor."
8
| Electro Flo® 6 Airway
| Clearance System | Electro Flo Percussor Model 5000 | Commentary |
|---|---|---|
| The Electro Flo® 6 Airway | ||
| Clearance System is | ||
| intended to provide Airway | ||
| Clearance Therapy and | ||
| promote bronchial drainage | ||
| where external manipulation | ||
| of the thorax is the | ||
| physician's choice of | ||
| treatment. It is indicated for | ||
| patients having difficulty | ||
| with secretion clearance, or | ||
| the presence of atelectasis | ||
| caused by mucus plugging. | The intended use of the Med Systems Electro Flo | |
| Percussor Model 5000 is the same as the predicate device, | ||
| which is to provide airway clearance therapy when | ||
| external manipulation of the thorax is the physician's | ||
| choice of treatment. Indications for this form of therapy | ||
| are described by the American Association for | ||
| Respiratory Care (AARC) in the Clinical Practices | ||
| Guidelines for Postural Drainage Therapy (1991). | ||
| According to AARC guidelines, specific indications for | ||
| external manipulation of the thorax include evidence or a | ||
| suggestion of retained secretions, evidence that the patient | ||
| is having difficulty with the secretion clearance, or | ||
| presence of atelectasis caused by mucus plugging. In | ||
| addition, the Med Systems Electro Flo Percussor Model | ||
| 5000 is also indicated for external manipulation of the | ||
| thorax to promote airway clearance or improve bronchial | ||
| drainage for purposes of collecting mucus for diagnostic | ||
| evaluation. | Substantially | |
| equivalent. |
The devices have the same intended use and are the identical technologically, as shown in the following table:
| Characteristic | Electro Flo® 6 Airway
Clearance System | Electro Flo Percussor
Model 5000 | Commentary |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------|
| Mechanism | Variable frequency
electromechanical
actuators. | Variable frequency
electromechanical
actuators. | Identical |
| Anatomic
positions of the
actuator(s) on the
thorax | Determined by the
therapist or patient
manually or aided by a
repositionable fabric self-
administrator strap. | Determined by the
therapist or patient
manually or aided by a
repositionable fabric self-
administrator strap. | Identical |
| Actuator motion | The electromechanical
actuator provides a
vibratory, shaking motion
to the body. | The electromechanical
actuator provides a
vibratory, shaking motion
to the body. | Identical |
| Type of device | Durable medical
equipment for home use. | Durable medical
equipment for home use. | Identical |
| Controller
Frequency range | 5 - 25 Hz | 5 - 25 Hz | Identical |
| Power supply | 120 V, 60 Hz AC | 120 V, 60 Hz AC | Identical |
| Weight | 1.5 Kg (Power Head) | 1.5 Kg (Power Head) | Identical |
Comparison of Technical Characteristics
XI. PERFORMANCE DATA
Safety and Electromagnetic Radiation
The Electro Flo® 6 system meets the following safety and electromagnetic radiation standards:
9
| Standard Reference | Titles |
|---|---|
| UL 60601-1:2003 | |
| Ed.1 +R:26Apr2006 | Medical Electrical Equipment - Part 1: General Requirements for |
| Safety | |
| CSA C22.2 #601.1:1990 | |
| Ed.1+G1;S1;A2;G2] | Medical Electrical Equipment - General Requirements |
| For Safety (R2005) | |
| EN60601-1-2 | Medical electrical equipment - Part 1: General requirements for |
| basic safety and essential performance | |
| EN55011 Class A | Industrial, scientific and medical equipment- Radio-frequency |
| disturbance characteristics, limits, and methods of measurement | |
| FCC Part 15 Subpart B | Unintentional radiators |
Bench Data
Med Systems. Inc. contracted with Aeromethod Precision Engineering and Manufacturing, San Diego, CA, to conduct testing to characterize the Electro Flo® 6 system's mechanical performance. The test objectives were to verify and document that the Electro Flo® 6 system can be described as a high frequency chest wall oscillator (HFCWO) and to demonstrate that the output can be controlled by the force applied by the user to the device, as expected from its force multiplier design principle.
The test assembly was designed to collect one-dimensional vibration data along the axis of the Power Head. The Power Head body was rigidly attached to a linear bearing that could slide along a linear guide track. An elastic material pressed on the Power Head created a Static Load to simulate hand pressure. The Power Head's anvil end was attached to a plastic cvlinder in contact with a load cell that measured the waveforms at a sampling rate of 1000 Hz over a one-second interval. Waveforms were collected at a full factorial sampling with three frequency settings (1,3,6) on the Control Box, three power settings (1,3,5) on the Control Box, and three static loads of one, three, and five pounds of force applied to the Power Head. BioMedical Strategies, White River Junction, VT computed power spectra of the waveforms in arbitrary power units.
Results
At all settings, most of the power generated by the Electro Flo® 6 system was in the acoustic frequency range of 16 - 127 Hz. Varying the static load could control the power output, as predicted by the force multiplier design principle.
Comparison with Predicates
The Electro Flo and the Monarch primary predicate have variable frequency and power output. The Electro Flo has additional control over power output via hand pressure. They operate in overlapping frequency ranges.
The Electro Flo 6 and the reference predicate Electro Flo 5000 are the identical hardware, with the same frequency range, power, and controllability.
SUBSTANTIAL EQUIVALENCE CONCLUSION XII.
Substantial Equivalence between the Electro Flo® 6 Airway Clearance System and the primary predicate Monarch Airway Clearance System is demonstrated by:
- Identical indications statements. ●
- Identical intended use. ●
10
- Substantially equivalent technological characteristics: .
- o Both employ electromechanical actuators;
- Both treat the same anatomic locations of the thorax; O
- Both provide a vibratory, shaking motion to the body; and o
- o Both operate over the same fundamental frequency range.
Substantial Equivalence between the Electro Flo® 6 Airway Clearance System and the reference predicate Electro Flo 5000 system is demonstrated by:
- Substantially equivalent indications statements. ●
- . Identical intended use.
- Identical technological characteristics. ●