(136 days)
No
The description focuses on standard electrical stimulation technology and software controlling pulse generation, with no mention of AI or ML capabilities for adapting treatment or analyzing data.
Yes
Explanation: The device is explicitly intended for therapeutic purposes, including improving blood circulation, enhancing muscle performance, and pain relief. These are all therapeutic applications.
No
The Revitive IX (OTC) is intended for electrical stimulation of muscles for purposes like supporting muscle function, improving blood circulation, and relieving pain. It is a treatment device, not a diagnostic one, as it does not identify or analyze a condition.
No
The device description clearly outlines multiple hardware components including foot pads, electrode pads, a remote control, and the main body constructed from ABS plastic. While software is mentioned as controlling the pulses, it is an integral part of a physical device.
Based on the provided information, the Revitive IX (OTC) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Revitive IX (OTC) Function: The Revitive IX (OTC) is a neuromuscular electrical stimulation (NMES) device that applies electrical impulses directly to the body's muscles and tissues. It does not analyze any specimens taken from the body.
- Intended Use: The intended use clearly describes stimulating muscles for various therapeutic purposes (improving circulation, muscle function, pain relief). This is a direct interaction with the body, not an analysis of a sample.
- Device Description: The description details foot pads and electrode pads that deliver electrical stimulation, an optional ankle movement feature, and a remote control. These are all components for delivering electrical therapy, not for analyzing biological samples.
Therefore, the Revitive IX (OTC) falls under the category of a therapeutic medical device that interacts directly with the body, rather than an In Vitro Diagnostic device that analyzes samples from the body.
N/A
Intended Use / Indications for Use
The Revitive IX (OTC) is intended to be used for electrical stimulation of the muscles of the lower leg for the purposes of supporting muscle function, and improving blood circulation. In addition Revitive IX (OTC) is intended to be used for electrical stimulation of sore and aching muscles to relieve pain. The device is intended for home use for 30 minutes per treatment with a maximum of 3 hours treatment time per day as required.
Revitive IX (OTC) is indicated for:
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance. ●
- For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.
Product codes
NGX, NUH
Device Description
The Revitive IX (OTC) consists of foot pads and/or electrode pads that deliver electrical stimulation to the lower limb muscles, electrode pads may also deliver electrical stimulation to muscles in the shoulder, waist, back and arms; an optional feature that allows for ankle movement during stimulation; a remote control; dust protectors for the electrode pads; and a user interface. Replacement electrode pads are available separately under 510(k) K132588.
Revitive IX (OTC) is a neuromuscular electrical stimulation (NMES) device that applies electrical impulses that are of sufficient intensity to produce an artificial contraction of the muscle tissue. The device delivers electrical stimulation to the lower limb muscles through foot pads and/or through electrode pads which may be positioned on the lower limb, waist, back or arms. The foot pads are made of conductive black nitrile butyl rubber (NBR) containing carbon, while the electrode pads are made from conductive carbon film coated with an adhesive hydrogel on a cloth backing. It has an optional IsoRocker™ feature that allows ankle movement during stimulation. When enabled, the lsoRocker™ allows Revitive IX (OTC) to tilt back and forth as the muscles contract and relax. The main body of the device is constructed from ABS plastic.
The Revitive IX (OTC) is intended for multiple uses in the home environment and is not provided sterile. The software included in the device controls the pulses generated by the device to stimulate the muscle. The software allows the device to generate various different shapes of pulses with different repetition rates, duration and magnitude. The Revitive IX (OTC) utilizes standard household AC/DC power supply with a 5V DC power adaptor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anatomical sites mentioned for stimulation include: healthy leg muscles, shoulder, waist, back, upper extremities (arms) and lower extremities (legs).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home environment
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
A Usability study was conducted to determine that the intended users can identify they are appropriate users of the device and to assess whether they can operate the device in a safe and effective manner based on their reading and following the directions for use contained in the device labeling. The Revitive IX (OTC) summative protocol design, conduct, and analysis followed FDA's human factors draft guidance for industry entitled, Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility and electromagnetic compatibility and safety testing, and other performance testing were conducted in accordance with the following standards:
- ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: Biological evaluation of medical devices. Tests for irritation and skin sensitization
- BS EN 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance
- BS EN 60601-1-2: Medical electrical equipment - part 1-2: general requirements for safety - collateral standard: electromagnetic compatibility - requirements and tests
- EN 60601-2-10: Medical Electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
- BS EN 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
In all instances, the Revitive IX (OTC) functioned as intended and the results observed were as expected.
A Usability study was conducted to determine that the intended users can identify they are appropriate users of the device and to assess whether they can operate the device in a safe and effective manner based on their reading and following the directions for use contained in the device labeling. The Revitive IX (OTC) summative protocol design, conduct, and analysis followed FDA's human factors draft guidance for industry entitled, Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011). In summary, it was established that the Revitive IX (OTC) device, as labeled, is safe and effective in the hands of the intended population and therefore is suitable for Over-The-Counter use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized symbol of three human profiles facing right, with flowing lines representing the concept of health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2015
Actegy, Ltd % John J. Smith, MD, JD Regulatory Counsel Hogan Lovells US LLP Columbia Square 555 13th Street, NW Washington, DC 20004
Re: K143207
Trade/Device Name: Revitive IX (OTC) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH Dated: November 7, 2014 Received: November 7, 2014
Dear Dr. Smith,
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. 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 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 (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name
Revitive IX (OTC)
Indications for Use (Describe)
- . To temporarily increase local blood circulation in healthy leq muscles.
- To stimulate healthy muscles in order to improve and facilitate muscle performance.
- . For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (leqs) due to strain from exercise or normal household duties.
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
Actegy's Revitive IX (OTC)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Actegy Ltd. Reflex Cain Road Bracknell Berkshire, RG12 1HL UK
| Phone: | +44(0) 1344 636 940 |
|---|---|
| Facsimile: | +44(0) 8452 255 612 |
| Contact Person: | Angela Glover |
|---|---|
| Date Prepared: | March 18, 2015 |
Name of Device and Name/Address of Sponsor
Revitive IX (OTC) - Model: RIX
- Actegy Ltd. Reflex Cain Road Bracknell Berkshire, RG12 1HL UK
Common or Usual Name
Muscle Stimulator, Neuromuscular electrical stimulation (NMES) device
Classification Name
Powered muscle stimulator for muscle conditioning, 21 C.F.R. § 890.5850, product code NGX/NUH
Predicate Devices
OTC EMS Stimulator Model MT1001 Shenzhen Dongdixin Technology Co. Ltd (K133965) Prospera OTC TENS Electronic Pulse Massager - PL009 (K122744) Revitive IX (RX), Model: RIX Actegy Ltd. (K123354)
4
Device Description
The Revitive IX (OTC) consists of foot pads and/or electrode pads that deliver electrical stimulation to the lower limb muscles, electrode pads may also deliver electrical stimulation to muscles in the shoulder, waist, back and arms; an optional feature that allows for ankle movement during stimulation; a remote control; dust protectors for the electrode pads; and a user interface. Replacement electrode pads are available separately under 510(k) K132588.
Revitive IX (OTC) is a neuromuscular electrical stimulation (NMES) device that applies electrical impulses that are of sufficient intensity to produce an artificial contraction of the muscle tissue. The device delivers electrical stimulation to the lower limb muscles through foot pads and/or through electrode pads which may be positioned on the lower limb, waist, back or arms. The foot pads are made of conductive black nitrile butyl rubber (NBR) containing carbon, while the electrode pads are made from conductive carbon film coated with an adhesive hydrogel on a cloth backing. It has an optional IsoRocker™ feature that allows ankle movement during stimulation. When enabled, the lsoRocker™ allows Revitive IX (OTC) to tilt back and forth as the muscles contract and relax. The main body of the device is constructed from ABS plastic.
The Revitive IX (OTC) is intended for multiple uses in the home environment and is not provided sterile. The software included in the device controls the pulses generated by the device to stimulate the muscle. The software allows the device to generate various different shapes of pulses with different repetition rates, duration and magnitude. The Revitive IX (OTC) utilizes standard household AC/DC power supply with a 5V DC power adaptor.
Intended Use / Indications for Use
The Revitive IX (OTC) is intended to be used for electrical stimulation of the muscles of the lower leg for the purposes of supporting muscle function, and improving blood circulation. In addition Revitive IX (OTC) is intended to be used for electrical stimulation of sore and aching muscles to relieve pain. The device is intended for home use for 30 minutes per treatment with a maximum of 3 hours treatment time per day as required.
Revitive IX (OTC) is indicated for:
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance. ●
- For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.
Technological Characteristics
The Revitive IX (OTC) is a mid-frequency (20-53Hz) Electrical Muscle Stimulator providing pulsed symmetrical biphasic, rectangular and bipolar waveforms utilizing Conductive Footpads & Self Adhesive Cutaneous Electrodes and rocker feature. The device provides an output current of 10-14mA@500Ω r.m.s. and maximum output voltage of 32V@500Ω. Intensity is controlled via the user
5
interface in 1-99 incremental steps. The duration of the treatment session can be set between 1 and 60 minutes.
Performance Data
Biocompatibility and electromagnetic compatibility and safety testing, and other performance testing were conducted in accordance with the following standards:
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
|---|---|
| ISO 10993-10 | Biological evaluation of medical devices. Tests for irritation and skin sensitization |
| BS EN 60601-1 | Medical electrical equipment. General requirements for basic safety and essential performance |
| BS EN 60601-1-2 | Medical electrical equipment - part 1-2: general requirements for safety - collateral standard: electromagnetic compatibility - requirements and tests |
| EN 60601-2-10 | Medical Electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators |
| BS EN 60601-1-11 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. |
In all instances, the Revitive IX (OTC) functioned as intended and the results observed were as expected.
A Usability study was conducted to determine that the intended users can identify they are appropriate users of the device and to assess whether they can operate the device in a safe and effective manner based on their reading and following the directions for use contained in the device labeling. The Revitive IX (OTC) summative protocol design, conduct, and analysis followed FDA's human factors draft guidance for industry entitled, Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011). In summary, it was established that the Revitive IX (OTC) device, as labeled, is safe and effective in the hands of the intended population and therefore is suitable for Over-The- Counter use.
Substantial Equivalence
The Revitive IX (OTC) is as safe and effective as its predicate devices. The Revitive IX (OTC) has the same technological characteristics, and principles of operation and similar indications and intended uses, as its predicate devices. The differences in Indications between the Revitive IX (OTC) and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Revitive IX (OTC) is as safe and effective as the predicate devices and is suitable for Over-The- Counter use. Thus, the Revitive IX (OTC) is substantially equivalent.
6
Actegy Ltd's
REVITIVE IX (OTC)
Substantial Equivalence Chart
| OTC TENS Electronic Pulse | ||||
|---|---|---|---|---|
| Revitive IX (OTC) | OTC EMS Stimulator | Massager - PL009 | Revitive IX (Rx) | |
| Candidate | Primary Predicate | Secondary Predicate | Secondary Predicate | |
| 510(k) Number | TBD | K133965 | K122744 | K123354 |
| Device Name, Model | REVITIVE IX (OTC), RIX | OTC EMS Stimulator, MT1001 | OTC TENS Electronic Pulse | |
| Massager - PL009 | REVITIVE IX (RX), RIX | |||
| Product Code: | NGX/NUH | NGX | NUH/NGX | IPF |
| Intended Use | Intended for electrical stimulation of | |||
| the lower leg and other muscles for | ||||
| various indications | Intended for electrical | |||
| stimulation of the lower leg for | ||||
| various indications | Intended for electrical | |||
| stimulation of tired and sore | ||||
| muscles | Intended for electrical | |||
| stimulation of the lower leg for | ||||
| various indications | ||||
| Indications for Use | To temporarily increase local blood | |||
| circulation in healthy leg muscles. | ||||
| To stimulate healthy muscles in order | ||||
| to improve and facilitate muscle | ||||
| performance. | ||||
| For temporary relief of pain | ||||
| associated with sore and aching | ||||
| muscles in the shoulder, waist, back, | ||||
| upper extremities (arms) and lower | ||||
| extremities (legs) due to strain from | ||||
| exercise or normal household duties. | The OTC EMS stimulator | |||
| MT1001 is intended to | ||||
| stimulate healthy muscles of | ||||
| the lower extremity in order to | ||||
| temporarily increase local | ||||
| blood circulation and to | ||||
| stimulate healthy muscles in | ||||
| order to improve and facilitate | ||||
| muscle performance. | To be used for temporary relief | |||
| of pain associated with sore | ||||
| and aching muscles in the | ||||
| shoulder, waist, back, neck, | ||||
| upper extremities (arm) and | ||||
| lower extremities (leg) due to | ||||
| strain from exercise or normal | ||||
| household activities. | 1. 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;
and - Maintaining or increasing
range of motion. |
| Technological Characteristics | Mid Frequency (20-53Hz) Electrical
Muscle Stimulator providing pulsed
symmetrical biphasic, rectangular and
bipolar waveforms utilizing
Conductive Footpads & Self Adhesive
Cutaneous Electrodes and rocker
feature | Mid Frequency (10-36Hz)
Electrical Muscle Stimulator
providing pulsed symmetrical
biphasic, rectangular and
bipolar waveforms utilizing
Conductive Footpads & Self
Adhesive Cutaneous
Electrodes and rocker feature | Mid Frequency (1-63Hz)
Electrical Muscle Stimulator
providing pulsed monophasic,
rectangular waveforms utilizing
Self Adhesive Cutaneous
Electrodes | Mid Frequency (20-53Hz)
Electrical Muscle Stimulator
providing pulsed symmetrical
biphasic, rectangular and
bipolar waveforms utilizing
Conductive Footpads & Self
Adhesive Cutaneous
Electrodes and rocker feature |
| Accessories | Self Adhesive Cutaneous Electrodes | Self Adhesive Cutaneous
Electrodes | Self Adhesive Cutaneous
Electrodes | Self Adhesive Cutaneous
Electrodes |
| | Revitive IX (OTC) | OTC EMS Stimulator | OTC TENS Electronic Pulse
Massager - PL009 | Revitive IX (Rx) |
| Manufacturer | Actegy Ltd | Shenzhen Dongdixin
Technology Co. Ltd. | Prospera Corporation | Actegy Ltd |
| Dimensions (mm) [W x H x D] | Ø360mm x 75mm | 427.3 x 416.5 x 103.7mm | 2.24 x 7.80 x 0.91in | Ø360mm x 75mm |
| Weight | 1725g (not including PSU) | 1910g (device only, excluding
batteries) | 8.21 oz | 1725g (not including PSU) |
| Power Source(s) | Power adaptor
Input: 100-240V, 50/60Hz, 0.18A.
Output: 5.0Vdc, 1.0A | Power adaptor
Input: 100-240V, 50/60Hz,
Output: 6.0Vdc, 300mA
Or 6.0Vdc, 4xC batteries | 6V battery | Power adaptor
Input: 100-240V, 50/60Hz,
0.18A.
Output: 5.0Vdc, 1.0A |
| Safety Features | Automatic Shut off, Override Control | Automatic Shut off, Override
Control | Automatic Shut off, Override
Control | Automatic Shut off, Override
Control |
| Biocompatibility | Yes | Unknown | Yes | Yes |
| Number of Output Modes | 1 | 1 | 3 | 1 |
| Number of Output Channels | 2 (1 for Foot, 1 for body pads) | 3 (2 for foot, 1 for body) | 2 | 2 (1 for Foot, 1 for body pads) |
| Software/Firmware/
Microprocessor Control? | Yes | Yes | Yes | Yes |
| Voltage/Current Level? | Yes: 1-99 intensity indicator | Yes: 1-99 intensity indicator | Yes: 1-10 intensity dial | Yes: 1-99 intensity indicator |
| Timer Range (minutes) | 1 to 60 minutes | 1 - 99 minutes | 15 minutes | 1 to 60 minutes |
| Compliance with Voluntary
Standards? | MDD (93/42EEC), EN 60601-1,
EN60601-1-2, EN 60601-1-11,
EN60601-2-10 | Unknown | IEC60601-1:
IEC60601-1-2;
IEC60601-2-10 | MDD (93/42EEC), EN 60601-1,
EN60601-1-2, EN 60601-1-11,
EN60601-2-10 |
| Compliance with 21 CFR 898? | Yes | Unknown | Yes | Yes |
| Housing Materials and
Construction | Casing/body ABS, footpads NBR | Unknown | Enclosure ABS | Casing/body ABS, footpads
NBR |
| Sterilization | Not provided sterile | Not provided sterile | Not provided sterile | Not provided sterile |
| Biocompatibility | Yes | Unknown | Yes | Yes |
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