As a TENS device, FD TENS 2090 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

As a EMS device. FD TENS 2090 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area. It is intended for:

Prevention or retardation of muscle disuse atrophy.
· Relaxation of muscle spasm.
· Muscle re-education.
· Maintaining or increasing range of motion.
· Increasing local blood circulation.
· Immediate post-surgical of calf muscle to prevent venous thrombosis.

FD TENS 2095 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Description

FD TENS 2090 can provide both TENS treatments and EMS treatments. During TENS treatments, the FD TENS 2090 generates electrical pulses and transmit it to the electrodes which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

During EMS treatments, FD TENS 2090 generates electrical pulses and transmit it to the electrodes attached to the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms. prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, reeducate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.

FD TENS 2095 can provide TENS treatment, During treatment, the FD TENS 2095 generates electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for medical devices named FD TENS 2090 and FD TENS 2095. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (FD TENS 2030 and FD EMS), rather than presenting a study to prove a device meets specific acceptance criteria for a novel AI or diagnostic function.

Therefore, many of the requested elements for an AI-focused study are not present in this document. However, I can extract the information relevant to the device's performance characteristics and how its equivalence was established.

No study proving the device meets specific acceptance criteria in the context of an AI or diagnostic function is described in this document. The document describes a "substantial equivalence" determination based on comparison to predicate devices, focusing on technical characteristics and intended use.

Here's a breakdown of the requested information based on the provided document. Many fields will indicate "Not applicable" or "Not provided" because the document is a 510(k) summary for a non-AI device.

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for TENS/EMS devices and not an AI or diagnostic device, there are no "acceptance criteria" in the traditional sense of diagnostic metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating that the new device's technical specifications and intended use are substantially equivalent to the predicate devices.

The "device performance" in this context is its electrical parameters compared to the predicate devices.

Characteristic	Acceptance Criteria (Predicate Device K052813 for TENS)	Reported Device Performance (FD TENS 2090/2095)	Acceptance Criteria (Predicate Device K063642 for EMS)	Reported Device Performance (FD TENS 2090)
Waveform	Symmetrical Bi-Phasic, Rectangular	Symmetrical Bi-Phasic, Rectangular	Symmetrical Bi-Phasic, Rectangular	Symmetrical Bi-Phasic, Rectangular
Max Voltage (0.5kΩ load)	31.3V	48.8V	48.7V	48.4V
Max Voltage (2kΩ load)	50.7V	70.4V	60.0V	67.2V
Max Voltage (10kΩ load)	85.0V	88.8V	64.7V	87.2V
Max Current (0.5kΩ load)	62.6 mA	97.6 mA	97.40 mA	96.8 mA
Max Current (2kΩ load)	25.35 mA	35.2 mA	30.0 mA	33.6 mA
Max Current (10kΩ load)	8.5 mA	8.88 mA	6.47 mA	8.72 mA
Max Pulse Width (TENS)	250μs	250μs	Not Applicable	Not Applicable
Max Pulse Width (EMS)	Not Applicable	Not Applicable	300μs	300μs
Max Frequency (TENS)	200 Hz	150 Hz	Not Applicable	Not Applicable
Max Frequency (EMS)	Not Applicable	Not Applicable	60 Hz	40 Hz
Max Output Net Charge per Phase (0.5kΩ load, TENS)	5.83μC	10.41 μC	Not Applicable	Not Applicable
Max Output Net Charge per Phase (0.5kΩ load, EMS)	Not Applicable	Not Applicable	3.57 μC	13.05μC
Max Power Density (TENS)	0.00182 W/cm²	0.00525 W/cm²	Not Applicable	Not Applicable
Max Power Density (EMS)	Not Applicable	Not Applicable	0.00614 W/cm²	0.00152 W/cm²
On Time (EMS)	1 to 9 sec adjustable	5 or 10 sec fixed	1 to 9 sec adjustable	5 or 10 sec fixed
Off Time (EMS)	1 to 9 sec adjustable	10 or 30 sec fixed	1 to 9 sec adjustable	10 or 30 sec fixed
Intended Use	Symptomatic relief/management of chronic intractable pain; adjunctive treatment for post-surgical/post-traumatic acute pain	Same	Prevention/retardation of muscle disuse atrophy; Relaxation of muscle spasm; Muscle re-education; Maintaining/increasing range of motion; Increasing local blood circulation; Immediate post-surgical of calf muscle to prevent venous thrombosis.	Same

Note: The subject device's electrical characteristics are sometimes numerically different from the predicate device but are deemed "substantially equivalent" for this type of device, implying they operate within acceptable and safe ranges for their intended therapeutic effect. The FDA clearance confirms this. For EMS's On/Off Time, the subject device has fixed times while the predicate has adjustable, which is a design difference but likely deemed acceptable for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable. This is not a study assessing diagnostic performance on a dataset but a technical comparison of device specifications to predicate devices.
Data provenance: Not applicable for a diagnostic test set. The data presented are engineering specifications of the devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of experts: Not applicable. Ground truth for a diagnostic test set is not relevant for this type of submission.
Qualifications of experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication method: Not applicable. No test set for diagnostic performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: No. This is not an AI-assisted diagnostic device.
Effect size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone performance: No. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of ground truth: Not applicable. The "ground truth" for this submission are the established technical specifications and performance characteristics of the legally marketed predicate devices, against which the new device's specifications are compared. The safety and effectiveness are established by meeting these engineering and performance standards, and through compliance with recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2).

8. The sample size for the training set

Sample size for training set: Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

Ground truth for training set: Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 22, 2016

Fuji Dynamics Ltd. Man Man Chung Product Development Manager 1-3. 23/F.. Laws Commerical Plaza 788 Cheung Sha Wan Road Hong Kong, China

Re: K152676

Trade/Device Name: FD TENS 2090 and FD TENS 2095 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: December 16, 2015 Received: December 21, 2015

Dear Man Man Chung:

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,

Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152676

Device Name FD TENS 2090 and FD TENS 2095

Indications for Use (Describe)

Prevention or retardation of muscle disuse atrophy.
· Relaxation of muscle spasm.
· Muscle re-education.
· Maintaining or increasing range of motion.
· Increasing local blood circulation.
· Immediate post-surgical of calf muscle to prevent venous thrombosis.

FD TENS 2095 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary [As required by 21 CFR 807.92]

Device 510(k) number: K152676

1. Applicant Information

Date prepared:	Aug 3, 2015
Submitter:	Fuji Dynamics Ltd.
	Unit 1-3, 23/F., Laws Commercial Plaza
	788 Cheung Sha Wan Road, Kowloon
	Hong Kong
Contact Person:	Man Man Chung
Tel:	(852) 2786 4218
Fax:	(852) 2744 6775

2. General Device Information/Trade name

Model No:	FD TENS 2090FD TENS 2095
Common Name:	Transcutaneous Elec

trical Nerve Stimulator and Powered Muscle Stimulator GZJ, IPF Product code: Classification: Class II

3. Predicate Device Information

510k number	Device Name	Manufacturer	Date cleared
K052813	FD TENS 2030	Fuji Dynamics	2006
K063642	FD EMS	Fuji Dynamics	2007

4. Device Description

FD TENS 2090

FD TENS 2095

{4}------------------------------------------------

5. Intended Use:

FD TENS 2090

As a EMS device, FD TENS 2090 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area. It is intended for:

· Prevention or retardation of muscle disuse atrophy.
Relaxation of muscle spasm.
· Muscle re-education.
· Maintaining or increasing range of motion.
· Increasing local blood circulation.
· Immediate post-surgical of calf muscle to prevent venous thrombosis.

FD TENS 2095

FD TENS 2095 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

6. Comparison to Predicate Device:

TENS Program comparison between FD TENS 2090, FD TENS 2095 and FD TENS 2030

Characteristic	Subject device K152676	Predicate device K052813
Device	FD TENS 2090 and FD TENS 2095	FD TENS 2030
Waveform	Symmetrical Bi-Phasic	Symmetrical Bi-Phasic
Shape	Rectangular	Rectangular
Maximum VoltageLoad: 0.50 kohm	(0-peak voltage)48.8V	(0-peak voltage)31.3V
02 kohm	70.4V	50.7V
10 kohm	88.8V	85.0V
Maximum CurrentLoad: 0.50 kohm	97.6 mA	62.6 mA
02 kohm	35.2 mA	25.35 mA
10 kohm	8.88 mA	8.5 mA
Maximum pulse width	250μs	250μs
Maximum frequency	150 Hz	200 Hz
Maximum OutputNet charge per phaseLoad: 500 ohm	10.41 μC	5.83μC
Maximum outputCharge per phaseLoad: 500 ohm	22.13μC	15.77μC
1kohm	16.33μC	13.60μC
Maximum outputRMS CurrentLoad: 500 ohm	11.55 mA rms	10.99 mA rms
1kohm	8.49 mA rms	8.95 mA rms
Max Current Density	0.15	0.1

{5}------------------------------------------------

(mA/cm²)	Max Power Density (W/cm²)
	.00525	.00182
Burst Mode	Burst 1	Burst II
a. Pulses per burst	7	7
b. Burst per second	2 bursts per second	2
c. Burst duration	250 ms	250ms
d. Duty cycle	50%	50%
	Burst 2	Burst I
a. Pulses per burst	80	80
b. Burst per second	1 burst per 2 seconds	1 burst per 2 seconds
c. Burst duration	1 second	1 second
d. Duty cycle	50%	50%
Continuous Mode	P1 CONST	CONSTANT
a. Pulse width	59µs default	50µs default
	Adjustable from 50µs to250µs	Adjustable from 25 to 250µs
b. Pulse frequency	120 Hz default	120 Hz default
	Adjustable from 1 to 150 Hz	Adjustable from 1 to 200 Hz
Pulse width modulation	P4 MODUL 1	W. MODUL
a. Pulse width	50µs to 250µs in 5s	25µs to 250µs in 8s
b. Pulse frequency	120Hz default	120 Hz default
	Adjustable from 1 to 150 Hz	Adjustable from 1 to 200 Hz
Frequency modulation	P5 MODUL 2	F. MODUL
a. Pulse frequency	20 to 100 Hz in 5s	20 to 100Hz in 8s
b. Pulse width	150µs default	50µs default
	Adjustable from 50 to 250µs	Adjustable from 25 to 250µs

EMS Program comparison between FD TENS 2090 and FD EMS

Characteristic	Subject device K152676	Predicate device K063642
Trade name	FD TENS 2090	FD EMS
Waveform	Symmetrical Bi-Phasic	Symmetrical Bi-Phasic
Shape	Rectangular	Rectangular
Maximum Voltage	(0 to peak voltage)	(0 to peak voltage)
Load: 500 ohm	48.4 V	48.7 V
2 kohm	67.2 V	60.0 V
10 kohm	87.2 V	64.7 V
Max Output current
Load: 500 ohm	96.8 mA	97.40 mA

{6}------------------------------------------------

2 kohm	33.6 mA	30.0 mA
10 kohm	8.72 mA	6.47 mA
Max pulse width	300μs	300μs
Max frequency	40 Hz	60 Hz
Biphasic waveform	Symmetrical Bi-PhasicRectangular Waveform	Symmetrical Bi-PhasicRectangular Waveform
- Symmetrical phases- Phase Duration	Fixed Pulse width, max 300 μs	Fixed Pulse width, max 300 μs
Maximum Output NetCharge Per PhaseLoad: 500 ohm	13.05μC	3.57 μC
Maximum Output ChargePer PhaseLoad: 500 ohm1 kohm	24.11 μC17.77 μC	48.61 μC28.77 μC
Maximum Output RMSCurrentLoad: 500 ohm1 kohm	6.62 mA rms4.91 mA rms	12.5 mA rms7.40 mA rms
Max Current Density(mA/cm2)	0.046	0.1966
Max Power Density (W/cm2)	0.00152	0.00614
On Time	5 or 10 sec fixed	1 to 9 sec adjustable
Off Time	10 or 30 sec fixed	1 to 9 sec adjustable
Output pattern -EMS Cycle Mode	Fixed pulse frequency, rampup/down and work/rest time.Only pulse width is userselectable.(P6,P8,P9)	Fixed pulse widthandwork/rest time.Selectable frequency and rampup/down time.
EMS Reciprocal Mode	Fixed pulse frequency, rampup/down and work/rest time.Only pulse width is userselectable(P7).	Fixed pulse width andwork/rest time.Selectable pulse frequency and rampup/down time.
Preset Program,P6 of subjectdevice	Program NameP6EMS ModeCycle modePules Freq: 35HzPulse width:300μsRamp up : 2secOn time : 10secRamp down : 2secOff time : 30sec	Program NameCYCLE 2EMS ModeCycle modePules Freq: 50Hz*Pulse width:300μsRamp up : 3secOn time : 9secRamp down : 3secOff time : 15sec
Preset Program,P7of subjectdevice	Program NameP7EMS ModeReciprocal modePules Freq: 40HzPulse width:300μs	Program NameRECIPROCAL 3EMS ModeReciprocalmodePules Freq: 50Hz*Pulse width:300μs

{7}------------------------------------------------

	Ramp up : 4sec	Ramp up : 4sec
	On time : 10sec	On time : 8sec
	Ramp down : 4sec	Ramp down :4sec
	Off time : 10sec	Off time : 14sec
Preset Program, P8	Program Name	Program Name
	P8	CYCLE 2
	EMS Mode	EMS Mode
	Cyclemode	Cycle mode
	Pules Freq: 40Hz	Pules Freq: 50Hz*
	Pulse width:300μs	Pulse width:300μs
	Ramp up : 4sec	Ramp up : 3sec
	On time : 10sec	On time : 9sec
	Ramp down : 4sec	Ramp down : 3sec
	Off time : 10sec	Off time : 15sec
Preset program P9	Program Name	Program Name
	P9	CYCLE 1
	EMS Mode	EMS Mode
	Cyclemode	Cycle mode
	Pules Freq: 20Hz	Pules Freq: 50Hz*
	Pulse width:200μs	Pulse width:300μs
	Ramp up : 2sec	Ramp up : 2sec
	On time : 5sec	On time : 6sec
	Ramp down : 2sec	Ramp down : 2sec
	Off time : 10sec	Off time : 10sec
Preset Program, P1	Program Name	Program Name
	P1	CONSTANT 1
	Pulse width:	Pulse width:
	120µs default	50 µs fixed
	Adjustable from	Pulse freq:
	50µs to 250µs	30Hz fixed
	Pulse freq:	--------------------
	120Hz default	Program Name
	adjustable from 1 to 150Hz	CONSTANT 2
		Pulse width
		200µs fixed
		Pulse freq:
		50Hz

7. Non clinical Testing

IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC 60601-1-2:2007 (Edition 3)

Safety requirement EMC requirement

8. Clinical testing

None

9. Conclusion

FD TENS 2090 and FD TENS 2095 have the same intended use and the same technical characteristics as the predicate device(s), FD TENS 2030 (K052813) and FD EMS (K063642). FD TENS 2090, FD TENS 2095 are as safe and as effective as the predicate device. Therefore, FD TENS 2090 and FD TENS 2095 are substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).