TimeWaver Frequency by TimeWaver Production GmbH

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

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.

AI/ML Overview

Sorry, but the provided text from the FDA 510(k) submission for the TimeWaver Frequency device ({0} through {14}) describes a substantial equivalence determination based on non-clinical testing and comparison to a predicate device, rather than a study with acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy.

The document states:

"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." (Page {5})
"All necessary non-clinical testing was conducted on the TimeWaver Frequency device to confirm that the device performs as intended." (Page {13})
The enumerated nonclinical tests include electrical safety and electromagnetic compatibility, biocompatibility verification, and software verification and validation. (Page {14})

There is no information within the provided text about:

Acceptance criteria related to clinical performance (e.g., sensitivity, specificity, accuracy).
A study specifically measuring device performance against such criteria.
Sample sizes for a clinical test set or data provenance.
Number of experts, their qualifications, or adjudication methods for ground truth.
A multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
A standalone algorithm performance study.
The type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for a clinical training set or how its ground truth was established.

The FDA 510(k) clearance process for this type of device (Powered Muscle Stimulator and Transcutaneous Electrical Nerve Stimulator) often relies on demonstrating substantial equivalence to a legally marketed predicate device through engineering and performance bench testing, rather than new clinical trials demonstrating efficacy or safety if the indications for use and technological characteristics are similar and do not raise new questions of safety or effectiveness.

Summary

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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

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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 MuscleStimulator	Primary Code
GZJ	882.5890	Transcutaneouselectrical nervestimulator	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

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DEVICE DESCRIPTION [807.92(a)(4)]

Indication for Use Statement

As an NMES device, indications are for the following conditions:

1. -Relaxation of muscle spasms
1. Retardation or prevention of disuse atrophy
1. Increased local blood circulation
1. -Re-Educating muscles
1. -Immediate post-surgical stimulation of leg and arm muscles
1. Maintaining or increasing range of motion.

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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 s2 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 s5 cycles	1.4 s	1, 2, 3, 4, 5, 6

As a TENS device, indications are for the following conditions:

1. Symptomatic relief and management of chronic intractable pain
1. 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 вવી 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 notraise different questionsof safety andeffectiveness
- 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 andeffectiveness
- Method of Line Current Isolation	Power Supply Adapter	N/A	Different, but does notraise different questionsof safety andeffectiveness
- Patient Leakage Current (uA)			Same
- normal Condition, uA	<100μA	Pass
	- Single Fault Condition, uA	<100μΑ	Pass
	Number of Output Modes	2	2	Same
	Number of Output Channels	2	2	Same
	- Synchronous or Alternating	Alternating	Unknown	Different, but does notraise different questionsof safety andeffectiveness
	- Method of Channel Isolation	galvanic isolation	Unknown	Different, but does notraise different questionsof safety andeffectiveness
	Regulated Current or RegulatedVoltage	both	both	Same
	Software/Firmware/MicroprocessorControl?	yes	yes	Same
	Automatic Overload Trip	yes	yes	Same
	Automatic No Load Trip	yes	yes	Same
	Automatic Shut Off	Yes, PC-software	Yes, PC-software	Same
	User Override Control	Yes, PC-software	Unknown	Different, but does notraise different questionsof safety andeffectiveness
	Indicator Display
	On/Off Status?	yes	yes	Same
	Low Battery?	yes	yes	Same
	Voltage/Current Level?	yes	Unknown	Different, but does notraise different questionsof safety andeffectiveness
Compliance with Voluntarystandards	IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-2-10ISO 10993-1: 2009ISO 10993-5	IEC 60601-1IEC 60606-1-2IEC 60601-2-10IEC 60601-1-6IEC 60601-1-11IEC 62366: 2007ISO 10993-1: 2009ISO 10993-5: 2009ISO 10993-10: 2010ISO 14971: 2007	Different, but does notraise different questionsof safety andeffectiveness

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510(k) Summary: K212832

Output Specification									Comparison
510(k) Number	Current Submission				K150413
Product Code (s)			IPF, GZJ		IPF (NMES), GZJ (TENS)				N/A
Device Name			TimeWaver Frequency		QB1 & QB1000				N/A
Manufacturer			TimeWaver Production GmbH		CyMedica Orthopedics Inc				N/A
Program Modes/Name	pulsedmonophasic	symmetricbiphasic	pulsedmonophasic	symmetricbiphasic	NEMSPost-Op	NEMSStrength	TENS		N/A
Output Mode (voltage or Current)	Current	Current	Voltage	Voltage	Both	Both	Both		Different,but doesnot raisedifferentquestionsof safetyandeffectiveness
Waveform	PulsedMonophasic	SymmetricBiphasic	PulsedMonophasic	SymmetricBiphasic	PulsedMonophasic	PulsedMonophasic	SymmetricBiphasic		Same
Shape	rectangle	rectangle	rectangle	rectangle	Complex	Complex	Complex		Different,but doesnot raise

								differentquestionsof safetyandeffectiveness
Max Output Voltage (V) +/- 20%
500 Ohms	0.25	0.10	5.0	2.0	3.4	3.4	0.180	Different,
2k Ohms	1.2	0.4	5.0	2.0	6.1	6.1	0.190	but doesnot raisedifferentquestionsof safetyandeffectiveness
10k Ohms	12.0	2.0	5.0	2.0	8.5	8.5	0.200
Max Output Current (mA) +/- 20%
500 Ohms	0.5	0.2	10.0	4.0	6.8	6.8	0.36	Different,
2k Ohms	0.5	0.2	2.5	1.0	3.0	3.0	0.10	but doesnot raise
10k Ohms	0.5	0.2	0.5	0.2	0.9	0.9	0.02	differentquestionsof safetyandeffectivenessss
Frequency, Hz	50	100	50	100	50	50	100	Same
Duration of primary (depolarizing)phase (u sec)	5000	1000	5000	1000	5000	5000	N/A(continuous)	Different,but doesnot raisedifferentquestionsof safetyand
								effectiveness
Pulse Duration, uSec	5000	1000	5000	1000	5000	5000	1000	Same
Net Charge uC per pulse	2.5	0(symmetricBiphasic)	50	0(symmetricBiphasic)	126	126	0(symmetricBiphasic)	Different,but doesnot raisedifferentquestionsof safetyandeffectiveness
Maximum Phase Charge (uC), 500Ohms	2.5	0.2	50	4	126	126	43	Different,but doesnot raisedifferentquestionsof safetyandeffectiveness
Maximum Current Density,mA/cm² @ 500 Ohms	0.020	0.008	0.400	0.160	0.270	0.270	0.014	Different,but doesnot raisedifferentquestionsof safetyandeffectiveness
Maximum Average Power Density[mW/cm²] @ 500 Ohms	0.005	0.001	2.000	0.320	1.000	1.000	0.0026	Different,but doesnot raisedifferentquestionsof safetyandeffectiveness

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							of safetyandeffectiveness


50 x 50 mm, 25 cm²	25.86 cm²	Different, but does not
50 x 90 mm, 45 cm²	51.61 cm²	raise different questions
	51.61 cm²	of safety andeffectiveness

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[As required by 21 CFR 807.92]

PREDICATE DEVICE(S) [807.92(a)(3)]

The TimeWaver Frequency device is substantially equivalent to the predicate device, the CyMedica Orthopedics QB1 powered Muscle Stimulator (NEMS) & Transcutaneous Electrical Nerve Stimulator (TENS) with regard to product labeling, intended use, performance testing, technological and safety characteristics.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES, [807.92(a)(6)]

Regarding technological characteristics, the TimeWaver Frequency device is similar to the predicate's functions with only minor technological differences.

The CyMedical QB-1 product is targeted at knee rehabilitation, while the TimeWaver Frequency is more traditional in its approach to NMES and TENS treatment leaving specific treatment options to the judgement of a medical professional. While the treatment areas are different the output parameters of both devices are quite similar.

The CyMedica device provides 3 electrodes, where the TimeWaver Frequency provides 2 electrodes, which is more common in NEMS and TENS devices, and allows the device to be used in multiple locations. The combined surface area of the CyMedica electrodes is 129 cm² and the TimeWaver Frequency is 90 cm². This does not pose new questions of safety or efficacy as the maximum power density and maximum current density is similar to the CyMedica device.

The CyMedica device is used in conjunction with a conductive garment to facilitate electrode placement for knee treatment. As a traditional NEMS/TENS device TimeWaver Frequency does not limit treatment application to the knee area. TimeWaver Frequency use is limited to health care professionals, where CyMedica allows home use, so limiting electrode placement to what is allowable with the garment is not required. This does not pose new questions of safety or efficacy.

The CyMedica device has only limited treatment options available to the user that are activated by simple on product buttons for Post Op or Strength and intensity level adjustment for knee or thigh treatment. The TimeWaver Frequency uses software installed on a PC to control the treatment applications at the direction of the medical professional. As the maximum outputs of the TimeWaver Frequency device are controlled by the software, this does not pose any new questions of safety or efficacy.

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 TimeWaver Frequency also passed all testing requirements for electrical safety and EMC, and the device adhesive electrode has been previously cleared by FDA. 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.

Performance Data [807.92(b)]

All necessary non-clinical testing was conducted on the TimeWaver Frequency device to confirm that the device performs as intended.

Nonclinical Testing Summary:

The nonclinical, bench testing included performance verification to confirm acceptable performance of device features and functions. Other nonclinical safety testing included:

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· 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.

Performance Data: Electromagnetic Compatibility and Electrical Safety

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 applicable electrical and safety standards met are:

IEC 60601-1:	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6	Medical electrical equipment Part 1-6 General requirements for safety - Collateral Standard: Usability
IEC 60601-2-10:	Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
ANSI/AAMI NS4:2013/(R)2017:	Transcutaneous electrical nerve stimulators

Software Validation

The TimeWaver Frequency device software was validated following FDA 's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices.

The applicable software validation standards met are:

EN ISO 13485: 2012 Medical devices -- Quality management systems -- Requirements for regulatory purposes EN ISO 14971: 2012 Medical devices - Application of risk management to medical devices EN 62304: 2006 Medical device software -- Software life cycle processes

Biocompatibility Data

Biocompatibility testing is not required because the primary patient contact surface is through the adhesive electrode which was previously cleared by FDA under K091163.

Conclusion

Based upon the intended use and technical information provided in this pre-market notification, the TimeWaver Frequency device has been shown to be substantially equivalent to the currently marketed predicate device.

Regulation Number and Section

§ 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).