(240 days)
Not Found
No
The summary describes a device that uses electrical stimulation for muscle therapy and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for medical purposes such as relaxation of muscle spasms, prevention of disuse atrophy, increasing blood circulation, muscle re-education, prevention of venous thrombosis, and maintaining or increasing range of motion, which are all therapeutic benefits.
No
Explanation: The Revitive IX's intended uses are therapeutic (e.g., relaxation of muscle spasms, increasing blood circulation, preventing disuse atrophy) rather than diagnostic. It does not mention identifying, analyzing, or classifying diseases or conditions.
No
The device description explicitly lists hardware components such as foot pads, electrode pads, an IsoRocker feature, and a remote control, indicating it is not a software-only device.
Based on the provided information, the Revitive IX is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed for the Revitive IX are all related to physical therapy and muscle stimulation. These are therapeutic applications, not diagnostic tests performed on samples taken from the body.
- Device Description: The device description details components that deliver electrical stimulation to muscles. This aligns with a therapeutic device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples like blood, urine, tissue, etc., which is the defining characteristic of an IVD.
In summary, the Revitive IX is a therapeutic device used for muscle stimulation and related physical benefits, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Revitive IX is indicated for:
- 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. .
Product codes
IPF
Device Description
The Revitive IX consists of foot pads and/or electrode pads that deliver electrical stimulation to the muscles; an optional feature that allows for ankle movement during stimulation (IsoRocker); a remote control; and a user interface.
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
Not Found
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)
Biocompatibility and electromagnetic compatibility and safety testing, and other performance testing were conducted. In all instances, the Revitive IX functioned as intended and the results observed were as expected.
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
K 123354
510(k) SUMMARY Actegy's Revitive IX
JUN 2 8 2013
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Actegy Ltd. 8 Queen Square, Ascot Business Park Lyndhurst Road Ascot Berkshire SL5 9FE വന
| Phone: | +44(0) 1344 636 940 |
|---|---|
| Facsimile: | +44(0) 8452 255 612 |
| Contact Person: | Josh Penny |
| Date Prepared: | June 27, 2013 |
Name of Device and Name/Address of Sponsor
Revitive IX
Actegy Ltd. 8 Queen Square, Ascot Business Park Lyndhurst Road Ascot Berkshire SL5 9FE UK
Common or Usual Name
Muscle Stimulator, Neuromuscular electrical stimulation (NMES) device
Classification Name
Powered muscle stimulator, 21 C.F.R. § 890.5850, Product code IPF
Predicate Devices
IF 3Wave Interferential Stimulator System, Model 711 OS, Compex Technologies, Inc. (K050046) Lifecare Garment Electrodes, Everyway Medical Instruments Co. Ltd. (K103719)
1
Intended Use / Indications for Use
The Revitive IX is indicated for:
- 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
The Revitive IX consists of foot pads and/or electrode pads that deliver electrical stimulation to the muscles; an optional feature that allows for ankle movement during stimulation (IsoRocker); a remote control; and a user interface. See the table below for a technological comparison with the predicate IF 3Wave.
Both Revitive IX and Compex IF 3Wave are mid-frequency (20-80Hz) muscle stimulator devices with biphasic pulses, and both operate in a range which balances between comfort and effective contractions. While there are minor differences in the values for certain of the technological features, the key parameters of the Revitive IX and Compex IF 3Wave are within the same range.
Performance Data
Biocompatibility and electromagnetic compatibility and safety testing, and other performance testing were conducted. In all instances, the Revitive IX functioned as intended and the results observed were as expected.
Substantial Equivalence
The Revitive IX is as safe and effective as the IF 3Wave Interferential Stimulator System and the Lifecare Garment Electrodes. The Revitive IX has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Revitive IX and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Revitive IX is as safe and effective as the predicate devices. Thus, the Revitive IX is substantially equivalent.
| Basic Unit Characteristics | ||
|---|---|---|
| Compex IF 3Wave - | ||
| NMES mode | Revitive IX | |
| 510(k) Number | K050046 | |
| Device Name, Model | IF 3Wave Model 7110S | REVITIVE IX, RIX |
| Manufacturer | Compex Technologies, Inc | Actegy Ltd |
| Power Source(s) | 3.6Vdc Lithium Ion | |
| Polymer rechargeable | ||
| battery, 3000mAh | Power adaptor | |
| Input: 100-240V, 50/60Hz, | ||
| 0.18A. | ||
| Output: 5.0Vdc, 1.0A | ||
| Method of Line Current Isolation | Transformers isolation | Transformers isolation |
| Basic Unit Characteristics | ||
| Compex IF 3Wave - | ||
| NMES mode | Revitive IX | |
| Patient Leakage Current2 | ||
| Normal condition ( $\mu$ A) |