Predicate Devices

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a simple electrical stimulator with pre-set modes and manual controls. There is no mention of adaptive algorithms, learning capabilities, or any technology that would typically be associated with AI/ML. The performance studies focus on electrical safety and standard compliance, not AI/ML performance metrics.

Therapeutic

Yes
The device is described as "electrically powered devices intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain," and its intended use is for "temporary relief of pain associated with sore and aching muscles." This fits the definition of a therapeutic device designed for pain relief.

Diagnostic

No

The device is described as applying an electrical current to electrodes on a user's skin to relieve pain, which is a therapeutic function, not a diagnostic one. Its intended use is for "temporary relief of pain associated with sore and aching muscles."

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components including an electrically powered device body, LCD display, attachment pads, and battery power source. While software verification is mentioned, it is in the context of software contained within a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic purpose, not a diagnostic one.
Device Description: The device applies electrical current to the skin to relieve pain. This is a form of electrical stimulation, not a test performed on biological samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific substances, or providing diagnostic information about a disease or condition.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on providing pain relief through electrical stimulation.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 work activities.

Product codes

NUJH, NGX, NUH

Device Description

PL009 and PL009A are electrically powered devices intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. It provides three selectable massage pulse styles with five auto operational modes through two channels with four attachment pads and shows graphic information about massage style, intensity and time remaining on a LCD based display which is incorporated with the device body. The device uses DC 6V power supplied by 4 AAA batteries. It is approximately 0.5lbs with dimensions 8" x 2" x 1" plus attachment pads. The only difference between PL009 and PL009A is the former has a button of "Repeat" representative of the function of repeat.

PL029 is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. It provides eight selectable massage pulse styles with five auto operational modes through two channels with four attachment pads and shows textual message about massage style, intensity and time remaining on a LCD based display which is incorporated with the device body. The device uses DC 3V power supplied by 2 AAA batteries. It is approximately 0.5lb with dimensions 8" x 2" x 1" plus attachment pads.

The differences between PL009 and PL029 include:

(1) PL009's work voltage is 6V supplied by 4 AAA batteries, while PL029's work voltage is 3V supplied by 2 AAA batteries.

(2) PL009 provides three operational modes, i.e., massage, beat and knead, which can be combined into six stimulation programs for WAIST, SHOULDER, JOINT, HAND-FOOT, REPEAT and SOLE, while PL029 provides eight operational, i.e., massage, beat, knead, slim, acupuncture, scraping, cupping and immune.

(3) PL009 uses mechanical potentiometer to control power and intensity, while PL029 uses electronic switches to control power and intensity.

(4) PL009's LCD display shows body parts in graphics when the device is in operation, while PL029's LCD display shows working modes in text only when the device is in operation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

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)

Non-clinical tests were performed on the subject matter device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, electromagnetic compatibility, and particular requirements for the safety of nerve and muscle stimulators:

a. EN55014-1: Electromagnetic compatibility-Requirements for household appliances, electric tocls, and similar apparatus-Part 1: Emission-Product family standard:
b. EN55014-2: Electromagnetic compatibility—Requirements for household appliances, electric tocks, and similar apparatus-Part 2: Immunity-Product family standard;
c. EN60335-1: Household and similar electrical appliances Safety Part 1: General Requirements;
d. EN60335-2: Safety of household and similar electrical appliances-Part 2: Particular requirements for massage appliances;
e. EN62233: Measurement methods for electromagnetic fields of household appliances and similar apparatus with regard to human exposure;
f. IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for safety;
g. IEC 60601-1-2 "Medical electrical equipment Part 1-2: General requirements for safety - Collateral Standard"; and
h. IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators".

In addition to the compliance of voluntary standards, the software verification has been carries out according to the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.

Electrodes, as accessories of the subject matter device, are also meet safety requirement.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K102598, K060846, K112392

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

510(k) K122744

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

I. Submitter's Information - 21 CFR §807.92(a)(1):

Prospera Corporation 405 Boulder Ct., Ste 500 Pleasanton, CA 94566 (925) 225-0888 Tel. (925) 225-0660 Fax Establishment Registration No. 3009049803

Contact Person: Jane Ding Date Prepared: September 6, 2012

II. Trade Name, Common Name & Classification - 21 CFR §807.92(a)(2):

Trade Name:	Prospera OTC TENS Electronic Pulse Massager
Models:	PL009; PL009A; PL029
Common Name:	Transcutaneous electrical nerve stimulator, OTC
Regulation Number:	21 CFR 882.5890
Regulation Name:	Transcutaneous Electrical Nerve Stimulator for pain relief
Regulatory Class:	II
Product Code:	NUJH, NGX
Use:	Over-The-Counter Use

III. Predicate Devices - 21 CFR §807.92(a)(3):

Prospera OTC TENS electronic pulse massager (herein after as "the subject matter device") is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. The subject matter device is substantially equivalent to the following legally marketed devices in safety and effectiveness:

1

510(k) No.	Classification	FDA Dated	Model
K102598	NUH
21 CFR §882.5890
NGX
21 CFR §882.5850
OTC	05/13/2011	JQ-5C	Hi-Dow International, Inc.
K060846	NUH
21 CFR §882.5890
NGX
21 CFR §882.5850
OTC	12/03/2007	T1040	Endurance Therapeutics
K112392	NUH
21 CFR §882.5890
OTC	03/19/2012	PP907	Hivox Biotek Inc.

The OTC predicate devices' description and indications for use:

.

510(k) No.	Description	Indications for Use
K102598	Portable, battery powered (3.7VDC)
multi function device offering both
Transcutaneous Electrical Nerve
Stimulator (TENS) and Powered
Muscle Stimulator (PMS) qualities in
one device. Double channels that
effectively transfers user's desired
choice of programmed electrical pulses
directly through electrode adhesive
pads to the suggested area of the body
where the electrodes are placed,
causing minimal muscle contractions.
There are 6 modes of operation.	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 work activities.
K060846	Pre-programmed electrical pulses are
transferred directly through electrode
adhesive pads to the suggested area
of the body where the electrodes are
placed, causing minimal muscle
contractions.	Temporary relief of pain
associated with sore and aching
muscles in the lower back due to
strain from exercise or normal
household and work activities.
K112392	The stimulator can generate small
pulses of electrical current. Delivered
these pulses pass through the skin and
activated underlying nerves.	Temporary relief of pain
associated with sore and aching
muscles in the lower back as well
as upper and lower extremities
(arm and/or leg) due to strain from
exercise or normal household and
work activities.

2 ・

. .

.

2

IV. Device Description - 21 CFR 21 CFR 21 CFR §807.92(a)(4):

PL009 and PL009A are electrically powered devices intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. It provides three selectable massage pulse styles with five auto operational modes through two channels with four attachment pads and shows graphic information about massage style, intensity and time remaining on a LCD based display which is incorporated with the device body. The device uses DC 6V power supplied by 4 AAA batteries. It is approximately 0.5lbs with dimensions 8" x 2" x 1" plus attachment pads. The only difference between PL009 and PL009A is the former has a button of "Repeat" representative of the function of repeat.

PL029 is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. It provides eight selectable massage pulse styles with five auto operational modes through two channels with four attachment pads and shows textual message about massage style, intensity and time remaining on a LCD based display which is incorporated with the device body. The device uses DC 3V power supplied by 2 AAA batteries. It is approximately 0.5lb with dimensions 8" x 2" x 1" plus attachment pads.

The differences between PL009 and PL029 include:

(1) PL009's work voltage is 6V supplied by 4 AAA batteries, while PL029's work voltage is 3V supplied by 2 AAA batteries.

(2) PL009 provides three operational modes, i.e., massage, beat and knead, which can be combined into six stimulation programs for WAIST, SHOULDER, JOINT, HAND-FOOT, REPEAT and SOLE, while PL029 provides eight operational, i.e., massage, beat, knead, slim, acupuncture, scraping, cupping and immune.

(3) PL009 uses mechanical potentiometer to control power and intensity, while PL029 uses electronic switches to control power and intensity.

(4) PL009's LCD display shows body parts in graphics when the device is in operation, while PL029's LCD display shows working modes in text only when the device is in operation.

3

V. Indication for Use - 21 CFR §807.92(a)(5):

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 work activities.

VI. Technical Characteristics - 21 CFR §807.92(a)(6):

The operational principle of the above listed OTC predicate devices is to generate small pulses of electrical current and deliver the pulses to an ordinary user's skin through electrode adhesive pads such that the underlying nerves are activated and the pain associated with sore and aching muscles is temporarily relieved.

Similarly, the operational principle of the subject matter device manufactured by the submitter is to generate small pulses of electrical current and deliver the pulses to an ordinary user's skin through electrode adhesive pads such that the underlying nerves are activated and the pain associated with sore and aching muscles is temporarily relieved.

Table 1, attached hereto, illustrates PLO09's and PL009A's comparison with the OTC predicate devices.

Table 2, attached hereto, illustrates PL029's comparison with the OTC predicate devices.

The data in Table 1 and Table 2 indicates that the technical characteristics, features, specifications and intended use of the subject matter device are substantially equivalent to those of the OTC predicate devices.

The design differences between the subject matter device and the OTC predicate devices are insignificant and do neither affect the intended use, nor alter the operational principle of the subject matter device.

Non-Clinical Tests Performed - 21 CFR §807.92(b)(1): VII.

Compliance to applicable voluntary standards includes IEC 60601-1 and IEC 60601-1-2.

4

Non-clinical tests were performed on the subject matter device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, electromagnetic compatibility, and particular requirements for the safety of nerve and muscle stimulators:

a. EN55014-1: Electromagnetic compatibility-Requirements for household appliances, electric tocls, and similar apparatus-Part 1: Emission-Product family standard:
b. EN55014-2: Electromagnetic compatibility—Requirements for household appliances, electric tocks, and similar apparatus-Part 2: Immunity-Product family standard;
c. EN60335-1: Household and similar electrical appliances Safety Part 1: General Requirements;
d. EN60335-2: Safety of household and similar electrical appliances-Part 2: Particular requirements for massage appliances;
e. EN62233: Measurement methods for electromagnetic fields of household appliances and similar apparatus with regard to human exposure;
ﺳﺘ IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for safety;
g. IEC 60601-1-2 "Medical electrical equipment Part 1-2: General requirements for safety - Collateral Standard"; and
h. IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators".

In addition to the compliance of voluntary standards, the software verification has been carries out according to the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.

Electrodes, as accessories of the subject matter device, are also meet safety requirement.

Conclusion - 21 CFR §807.92(b)(3): VIII.

The product description, the non-clinical tests performed and the comparison of technical characteristics demonstrate that the subject matter device is as safe, as effective, and performs as well as or better than the foregoing identified OTC predicate devices which are legally marketed in the United States.

5

Parameter	Your Device	Predicate
510(k) Number	K122744	K122744	K122744	K102598	K112392	K060846
Device Name and Model
Manufacturer	PL009
Prospera	PL009
Prospera	PL029
Prospera	JQ-5C
Hi-Dow
international Inc	PP907
HIVOX
BIOTEK INC	T1040
Endurance
Therapeutics
Power Source(s)	6V Battery
Battery Supply N/A	6V Battery
Battery Supply N/A	3V Battery
Battery Supply N/A	3.7V Lithium
Battery Supply N/A	3V Battery
Battery Supply	4.5V Battery
Battery Supply
Patient Leakage Current
- Normal Condition (μA)	1.8μΑ	1.8μΑ	2.0μΑ	2.0μΑ	NA	NA
- Single Fault Condition (μΑ)	3.3μΑ	3.3μΑ	3.0μΑ	4.2μΑ	NA	NA
Average DC current through electrodes when
device is on but no pulses are being applied	ΟμΑ	ΟμΑ	ΟμΑ	ΟμΑ	ΟμΑ	ΟμΑ
Number of Output Modes	3	3	8	6	1	10
Number of Output
Channels:	Synchronous	Synchronous	Alternating	Synchronous	Synchronous	Synchronous
Method of Channel Isolation	ON/OFF switch	ON/OFF switch	By software	ON/OFF switch	ON/OFF switch	ON/OFF switch
Regulated Current or Regulated Voltage?	Voltage control	Voltage control	Voltage control	Voltage control	Voltage control	Voltage control
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Yes	Yes	Yes
Automatic Overload Trip?	No	No	No	No	No	No
Automatic No-Load Trip?	No	No	No	No	No	No
Automatic Shut Off?	Yes	Yes	Yes	Yes	Yes	No
User Override Control?	Yes	Yes	Yes	Yes	Yes	Yes
Indicator Display:
On/Off Status?	Yes	Yes	Yes	Yes	No	Yes
Low Battery?	No	No	No	No	No	No
Voltage/Current	No	No	No	No	No	No
Timer Range (minutes)	15 min	15 min	5 min, 10min,		20min
Compliance with Voluntary Standards?	Yes	yes	Yes.		Yes	Yes
Compliance with 21 CFR 898?	Yes	yes	Yes	Yes	Yes	Yes
Weight (lbs., oz.)	0 lb., 8.21 oz.	0 lb., 8.21 oz.	0 lb., 6.40 oz		0 lb.,0.53 oz.	0lbs, 14.4 oz
Dimensions (in.) [W x H x D]	2.24 x 7.80 x 0.91	2.24 x 7.80 x 0.91	2.32 x 7.87 x 0.83	4.45 x 2.76 x 0..38	3.55 x	6 x 1 x 2.8
Housing Materials and Construction	Enclosure: ABS	Enclosure: ABS	Enclosure: ABS	ABS	silicone	ABS

K122744, 510(K) SUMMARY, TABLE A: Comparisons of PL009/PL009A/PL029 Basic Unit Characteristics with Predicate Devices:

:

6

K122744, 510(K) SUMMARY, TABLE B: PL009 & PL 009A'S COMPARISON WITH PREDICATE DEVICES

.

1 、

:

| Parameter | PL009
K122744 | PL009A
K122744 | JQ-5C
K102598 | PP909
K112392 | PP907
K112392 | PP904
K112392 | T1040
K060846 | |
|---------------------------------------------------|-----------------------------|-------------------------|------------------|-------------------------|-------------------------|-------------------------|------------------|-----|
| Waveform | Monophasic | Monophasic | Monophasic | Symmetrical
biphasic | Symmetrical
biphasic | Symmetrical
biphasic | Biphasic | |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| Maximum output voltage
(Volts +/- 20%) at 500Ω | 12.8 | 12.8 | 62.4 | 40.0 | 68.8 | 57.6 | 40.7 | |
| Maximum output voltage
(Volts +/- 20%) at 2KΩ | 51 | 51 | 79.2 | 84.0 | 88.0 | 89.6 | 105.1 | |
| Maximum output voltage
(Volts +/-20%) at 10kΩ | 368 | 368 | 84 | 92.0 | 95.2 | 96.0 | 154.1 | |
| Maximum output current (mA
+/- 20%) at 500Ω | 15 mA | 15 mA | 124.8 | 80.0 | 137.6mA | 115.2 | 81.4 | |
| Maximum output current (mA
+/- 20%) at 2KΩ | 3.2 mA | 3.2 mA | 39.6 | 42.0 | 44.0mA | 44.8 | 47.8 | |
| Maximum output current (mA
+/- 20%) at 10KΩ | 0.6 mA | 0.6 mA | 8.4 | 9.2 | 9.52mA | 9.6 | 15.4 | |
| Duration of primary
(depolarizing phase (µSec) | 40 nsec | 40 nsec | N/A | N/A | N/A | N/A | N/A | |
| Pulse Duration (µSec) | 120-6800 µSec | 120-6800 µSec | 16.3-781mS | 200 µSec
(fixed) | 200 µSec (fixed) | 200 µSec (fixed) | 4.1~500mS | |
| Frequency (Hz) | 1-100 | 1-100 | 61.3 | 35 | 2 and 40 | 2, 5, and 40 | 245Hz | |
| Net Charge per pulse (µC) at
500Ω | 18000 µC | 18000 µC | N/A | 0.3200 | 1.1008 | 0.2304 | 4.07 | |
| Maximum charge (µC) at
500Ω | 23 µC | 23 µC | 17.92 | 16.0 | 27.52 | 23.04 | 16.9 | |
| Maximum current density
(mA/cm²) at 500Ω | 1.4 mA/cm² | 1.4 mA/cm² | 9.92 | 1.964 | 3.378 | 2.828 | 2.71 | |
| Maximum average power
density (W/cm²) at 500Ω | 0.23 W/cm² | 0.23 W/cm² | 2.72 | 0.078 | 0.232 | 0.163 | 5.35 (mW/cm²) | |
| Burst
Mode | (a) Pulse per burst | 1 | 1 | N/A | 1 | N/A | N/A | N/A |
| | (b) Burst per second | 0-25 | 0-25 | N/A | 4 | N/A | N/A | N/A |
| | (c) Burst-duration
(sec) | 1 | 1 | N/A | 2 | N/A | N/A | N/A |
| | (d) Duty Cycle | 5 | 5 | N/A | 8 | N/A | N/A | N/A |
| ON time (sec) | Potentiometer
switch | Potentiometer
switch | N/A | 120 | 120 | 120 | N/A | |
| OFF time (sec) | Potentiometer
switch | Potentiometer
switch | N/A | 0 | 0 | 0 | N/A | |
| Additional features | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |

.

: :

7

K122744, 510(K) SUMMARY, TABLE C: PL029'S COMPARISON WITH PREDICATE DEVICES

| Parameters | PL029
K122744
Monophasic | JQ-5C
K102598
Monophasic | PP909
K112392
Symmetrical biphasic | PP907
K112392
Symmetrical biphasic | PP904
K112392
Symmetrical biphasic | T1040
K060846
Biphasic | |
|------------------------------------------------|--------------------------------|--------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------|-----|
| Waveform
Shape | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| Maximum output voltage (Volts +/- 20%) at 500Ω | 49.6 | 62.4 | 40.0 | 68.8 | 57.6 | 40.7 | |
| Maximum output voltage (Volts +/- 20%) at 2KΩ | 99.2 | 79.2 | 84.0 | 88.0 | 89.6 | 105.1 | |
| Maximum output voltage (Volts +/- 20%) at 10kΩ | 114 | 84 | 92.0 | 95.2 | 96.0 | 154.1 | |
| Maximum output current (mA +/- 20%) at 500Ω | 18 mA | 124.8 | 80.0 | 137.6mA | 115.2 | 81.4 | |
| Maximum output current (mA +/- 20%) at 2KΩ | 3.2 mA | 39.6 | 42.0 | 44.0mA | 44.8 | 47.8 | |
| Maximum output current (mA +/- 20%) at 10KΩ | 0.6 mA | 8.4 | 9.2 | 9.52mA | 9.6 | 15.4 | |
| Duration of primary (depolarizing phase (µSec) | 40 msec | N/A | N/A | N/A | N/A | N/A | |
| Pulse Duration (µSec) | 100-200 µSec | 16.3-781mS | 200 µSec (fixed) | 200 µSec (fixed) | 200 µSec (fixed) | 4.1~500mS | |
| Frequency (Hz) | 0.5-86Hz | 61.3 | 35 | 2 and 40 | 2, 5, and 40 | 245Hz | |
| Net Charge per pulse (µC) at 500Ω | 18000 µC | N/A | 0.3200 | 1.1008 | 0.2304 | 4.07 | |
| Maximum charge (µC) at 500Ω | 23 | 17.92 | 16.0 | 27.52 | 23.04 | 16.9 | |
| Maximum current density (mA/cm²) at 500Ω | 1.4 mA/cm² | 9.92 | 1.964 | 3.378 | 2.828 | 2.71 | |
| Maximum average power density (W/cm²) at 500Ω | 0.23 W/cm² | 2.72 | 0.078 | 0.232 | 0.163 | 5.35 (mW/cm²) | |
| Burst
Mode | A. Pulse per burst | 1 | N/A | 1 | N/A | N/A | N/A |
| | B.Burst per second | 0-7 | N/A | 4 | N/A | N/A | N/A |
| | C.Burst-duration (sec) | 1 | N/A | 2 | N/A | N/A | N/A |
| | D.Duty Cycle | | N/A | 8 | N/A | N/A | N/A |
| ON time (sec) | 7 | N/A | 120 | 120 | 120 | N/A | |
| OFF time (sec) | 40 ms | N/A | 0 | 0 | 0 | N/A | |
| Additional features | 18 ms | N/A | N/A | N/A | N/A | N/A | |

·

8

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

March 28, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Prospera Corporation % Mr. Leon E. Jew Attorney at Law Dayhee Law Group 5776 Stoneridge Mall Rd., Suite 288 Pleasanton, CA 94588

Re: K122744

Trade/Device Name: OTC TENS Electronic Pulse Massager Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: NUH, NGX Dated: March 15, 2013 Received: March 18, 2013

Dear Mr. Jew:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

9

Page 2 - Leon E. Jew

forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

10

INDICATIONS FOR USE

510(k) Number (if known): K122744

Device Name: PROSPERA OTC TENS Electronic Pulse Massager

Models: PL009: PL009A; PL029

Indications for Use:

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 work activities.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE IDO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Victor Kra 2013.03.28 G

Division of Neurological and Physical Medicine Devices 510(k) Number: _K122744