(98 days)
No
The description focuses on standard electrical stimulation principles and software control for program selection, with no mention of adaptive algorithms, learning, or AI/ML terminology.
Yes
The device is described as an electrical stimulation device for treating specific medical conditions (NMES and TENS), which are therapeutic uses.
No
The device is an electrical stimulation device intended for treatment, not for diagnosing conditions. Its indications for use include relaxation of muscle spasms, pain relief, and muscle re-education.
No
The device description explicitly states that the TimeWaver Frequency device is an electrical stimulation device with hardware components (power supply, USB cable, electrode connector cables, electrodes) that deliver the stimulation, even though it is controlled by application software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The TimeWaver Frequency device is an electrical stimulation device that applies currents to the body through electrodes. It is used for therapeutic purposes (muscle stimulation and pain relief) and does not involve the analysis of biological specimens.
- Intended Use: The stated intended uses are for treating various physical conditions through electrical stimulation, not for diagnosing or analyzing samples.
- Device Description: The description focuses on the electrical stimulation capabilities, treatment programs, and application through electrodes. There is no mention of handling or analyzing biological samples.
Therefore, the TimeWaver Frequency device falls under the category of therapeutic electrical stimulation devices (specifically NMES and TENS), not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
As an NMES device, indications are for the following conditions:
-Relaxation of muscle spasms
-Retardation or prevention of disuse atrophy
-Increased local blood circulation
-Re-Educating muscles
-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
-Maintaining or increasing range of motion.
As a TENS device, indications are for the following conditions: -Symptomatic relief and management of chronic intractable pain -Adjunctive treatment for post-surgical and post-traumatic acute pain
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ
Device Description
TimeWaver Frequency is an electrical stimulation device that supports the treatment of specific medical conditions, using currents in the microampere range with different frequencies. It can be applied to different areas of the body and is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that deliver neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulations (TENS).
The TimeWaver Frequency device is a prescription device intended to be used by healthcare providers in a healthcare setting and is not approved for use in a home environment. The use of the device on a particular patient is solely the decision of the medical professional, who is responsible for having the proper training and exercising his or her informed medical judgement.
The principals of electrotherapy correspond to the process observed during voluntary muscle contraction. NMES pulses stimulate motor points of target muscle contraction. This can help reeducate and strengthen muscles following injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways.
The TimeWaver Frequency device provides 6 treatment programs for NEMS and two treatment programs for TENS. The NMES programs are for relaxation of muscle spasms, disuse atrophy, blood circulations, re-educating muscles, stimulation of calf muscles, and range of motion. The TENS programs are for chronic pain and acute pain. In all modes adhesive electrodes are used to deliver the stimulation.
The TimeWaver Frequency is controlled by an application software program. A personal computer or a notebook is necessary to install the application software and is not provided with the TimeWaver Frequency system. The TimeWaver Frequency software must be used as a stand-alone application on its own computer, which is not used for other software applications. The user interface has several sections. The title bar contains the current program version, the lower status bar shows if hardware components are correctly connected, and the menu bar allows selection of the section to work within. The software requires setting up a new client to include relevant patient information. Treatments are conducted by selecting the appropriate treatment from the Programs module.
The TimeWaver Frequency device operates using an external power supply and/or an internal battery. It is supplied with instructions for use, the TimeWaver Frequency device, power supply, USB cable, electrode connector cables, 50mm x 50mm and 50mm x 90 mm adhesive electrodes.
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
healthcare providers in a healthcare setting
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)
The nonclinical, bench testing included performance verification to confirm acceptable performance of device features and functions. Other nonclinical safety testing included: Electrical safety and electromagnetic compatibility testing, Biocompatibility verification, Software verification and validation.
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the TimeWaver Frequency meet the established specifications.
The TimeWaver Frequency device has been thoroughly tested against applicable EN and IEC standards by a third party and found to be compliant with the applicable sections. It was functionally tested and found to be compliant with the specification.
The TimeWaver Frequency device software was validated following FDA 's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices.
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.
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.
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/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2021
TimeWaver Production GmbH % Douglas Herrington Principal Consultant Herrington Consulting LLC 2885 Sanford Ave SW 43083 Grandville, Michigan 49418
Re: K212832
Trade/Device Name: TimeWaver Frequency Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF. GZJ Dated: August 2, 2021 Received: September 7, 2021
Dear Douglas Herrington:
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,
CDR Jitendra Virani, MS Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212832
Device Name TimeWaver Frequency
Indications for Use (Describe)
As an NMES device, indications are for the following conditions:
-Relaxation of muscle spasms
-Retardation or prevention of disuse atrophy
-Increased local blood circulation
-Re-Educating muscles
-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
-Maintaining or increasing range of motion.
As a TENS device, indications are for the following conditions: -Symptomatic relief and management of chronic intractable pain -Adjunctive treatment for post-surgical and post-traumatic acute pain
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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[As required by 21 CFR 807.92]
General Information
Date: December 13, 2021
Type of 510(k) Submission: Traditional 510(k) Notification
Sponsor & Manufacturing Address:
TimeWaver Production GmbH Schloss Kränzlin, Darritzer Straße 6 16818 Kränzlin, Germany Phone: +49 3391 40022-11 FAX: +49 3391 40022-99 Registration Number: 3009411292
Official Contact Name
Douglas Herrington Principal Consultant Herrington Consulting LLC 2885 Sanford Ave, SW#43083 Grandville, MI 49418-1342 Telephone: 1.248.369.5564 Fax: 1.877.881.4412 E-mail: dgls herrington@yahoo.com
Regulatory Information
Device Name: TimeWaver Frequency Model Number: REF 0002
Panel Code: 89 Physical Medicine Classification: Class II Product Code(s) and Regulation Numbers:
| Product Code | Regulations Number | Regulation Name | |
|---|---|---|---|
| IPF | 890.5850 | Powered Muscle | |
| Stimulator | Primary Code | ||
| GZJ | 882.5890 | Transcutaneous | |
| electrical nerve | |||
| stimulator | Secondary Code |
Predicate Device 510k Number: K150413. Manufacturer: CyMedica Orthopedics Model: QB1 Powered Muscle Stimulator System (NMES) & Transcutaneous Electrical Nerve Stimulator (TENS) QB-1000 Classification: Class II
4
DEVICE DESCRIPTION [807.92(a)(4)]
TimeWaver Frequency is an electrical stimulation device that supports the treatment of specific medical conditions, using currents in the microampere range with different frequencies. It can be applied to different areas of the body and is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that deliver neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulations (TENS).
The TimeWaver Frequency device is a prescription device intended to be used by healthcare providers in a healthcare setting and is not approved for use in a home environment. The use of the device on a particular patient is solely the decision of the medical professional, who is responsible for having the proper training and exercising his or her informed medical judgement.
The principals of electrotherapy correspond to the process observed during voluntary muscle contraction. NMES pulses stimulate motor points of target muscle contraction. This can help reeducate and strengthen muscles following injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways.
The TimeWaver Frequency device provides 6 treatment programs for NEMS and two treatment programs for TENS. The NMES programs are for relaxation of muscle spasms, disuse atrophy, blood circulations, re-educating muscles, stimulation of calf muscles, and range of motion. The TENS programs are for chronic pain and acute pain. In all modes adhesive electrodes are used to deliver the stimulation.
The TimeWaver Frequency is controlled by an application software program. A personal computer or a notebook is necessary to install the application software and is not provided with the TimeWaver Frequency system. The TimeWaver Frequency software must be used as a stand-alone application on its own computer, which is not used for other software applications. The user interface has several sections. The title bar contains the current program version, the lower status bar shows if hardware components are correctly connected, and the menu bar allows selection of the section to work within. The software requires setting up a new client to include relevant patient information. Treatments are conducted by selecting the appropriate treatment from the Programs module.
The TimeWaver Frequency device operates using an external power supply and/or an internal battery. It is supplied with instructions for use, the TimeWaver Frequency device, power supply, USB cable, electrode connector cables, 50mm x 50mm and 50mm x 90 mm adhesive electrodes.
Indication for Use Statement
As an NMES device, indications are for the following conditions:
-
- -Relaxation of muscle spasms
-
- Retardation or prevention of disuse atrophy
-
- Increased local blood circulation
-
- -Re-Educating muscles
-
- -Immediate post-surgical stimulation of leg and arm muscles
-
- Maintaining or increasing range of motion.
5
| Treatment Program | Pulse Shape | Duration | Frequency | Pulse Width | Duty Cycle | Work Cycle | Relaxation Time | Contraction Time | Rest Time | Indication Numbers |
|---|---|---|---|---|---|---|---|---|---|---|
| NMES Post-Op | Monophasic | 20 min | 50 pps | 5 ms | 25 % | 13 s | 10 s | 3 s | ||
| 2 cycles | 3.4 s | 1, 2, 3, 4, 5, 6 | ||||||||
| NMES Strength | Monophasic | 20 min | 50 pps | 5 ms | 25 % | 13 s | 10 s | 1 s | ||
| 5 cycles | 1.4 s | 1, 2, 3, 4, 5, 6 |
As a TENS device, indications are for the following conditions:
-
- Symptomatic relief and management of chronic intractable pain
-
- Adjunctive treatment for post-surgical and post-traumatic acute pain
| TENS Pain Management | Biphasic. symmetrical | 20 min 100 pps | 1 ms | 20% | Continuous | 1 4 ms | ставите седание в седание в сединание в седение в седение в сединание в седение в седение в сединание в сединание в седение в сединание в сединание в сединание в сединание в
વી છ |
|----------------------|-----------------------|------------------|------|-----|------------|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
Comparison of Technological Characteristics with the Predicate Device
Considering technological characteristics, the TimeWaver Frequency device is similar to the predicate with only minor differences.
The TimeWaver Frequency and CyMedica QB-1 devices are both electrotherapy devices with the two treatment modes of neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). They are both prescription devices intended for use under the direction of a medical provider and have the same indications for use. In addition, both products have the same product codes IPF (CFR 890.5850) and GZJ (CFR 882.5890).
In general, the TimeWaver Frequency output parameters are substantially the same as the output parameters for CyMedica OB-1. For example, the maximum current density (mA/cm2) for TimeWaver Frequency @ 500 ohms is 0.16, while the CyMedica QB-1 is 0.27. The maximum average power density (mW/cm2) @500 ohms is 2.0 for TimeWaver Frequency, whereas the CyMedica QB-1 maximum average power density @500 ohms is 1.0. The TimeWaver Frequency and CyMedica OB-1 both use pulsed monophasic and symmetric biphasic to deliver treatment programs.
TimeWaver has completed comprehensive design verification testing, electrical safety and electromagnetic compatibility testing, software verification and validation to ensure that the TimeWaver Frequency device performs as intended. The patient-contacting material has been verified to demonstrate acceptable biocompatibility. The electrodes and cables comply with 21 CFR 898, so they do not raise new questions of safety or effectiveness.
The minor differences in labeling and technological characteristics between the proposed device and the predicate device have been evaluated and determined to not raise different questions of safety or effectiveness. As such, the proposed TimeWaver Frequency is substantially equivalent to the predicate device.
The following table summarizes the specifications and features of the proposed TimeWaver Frequency device and the predicate device.
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Substantial Equivalence Summary
| Basic Unit Characteristics | |||
|---|---|---|---|
| 510(k) Number | Current Submission | K150413 | Comparison |
| Device Name/Model | TimeWaver Frequency, REF 0002 | QB1 & QB-1000, (NEMS) & (TENS) | N/A |
| Indications for Use | As an NMES device, indications are for the following conditions: | ||
| -Relaxation of muscle spasms | |||
| -Retardation or prevention of disuse atrophy | |||
| -Increased local blood circulation | |||
| -Re-Educating muscles | |||
| -Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis | |||
| -Maintaining or increasing range of motion. | |||
| As a TENS device, indications are for the following conditions: | |||
| -Symptomatic relief and management of chronic intractable pain | |||
| -Adjunctive treatment for post-surgical and post-traumatic acute pain | The QB1 Powered Muscle Stimulator System (NMES) &Transcutaneous Electrical Nerve Stimulator System (TENS); QB-1000 is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). |
Indications for Use:
As an NMES device, indications are for the following conditions:
- Relaxation of muscle spasms
- Retardation or prevention of disuse atrophy
- Increasing local blood circulation | Same |
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| Manufacturer | TimeWaver Production GmbH | CyMedica Orthopedics Inc | N/A | |
|---|---|---|---|---|
| Power Source: | Power Supply Adapter/Battery | Battery | Different, but does not | |
| raise different questions | ||||
| of safety and | ||||
| effectiveness | ||||
| - Battery | ||||
| - Number | 1 | 1 | ||
| - Size | 3200 mAh, 3.7 V | 3.7V | ||
| - Type | Lithium Polymer | Lithium Ion | ||
| - Power Supply Adapter | Different, but does not | |||
| - Input | 100 - 240 V AC, 50 - 60 Hz, 0.5 A | N/A | raise different questions | |
| - Output | 9 V DC, 2.0 A | N/A | of safety and | |
| effectiveness | ||||
| - Method of Line Current Isolation | Power Supply Adapter | N/A | Different, but does not | |
| raise different questions | ||||
| of safety and | ||||
| effectiveness | ||||
| - Patient Leakage Current (uA) | Same | |||
| - normal Condition, uA |