(202 days)
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.
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.
Here's an analysis of the provided 510(k) summary for the Prospera OTC TENS Electronic Pulse Massager, structured to address your specific questions.
Important Note: The provided document is a 510(k) Summary, which is designed to demonstrate substantial equivalence to previously marketed devices, not necessarily to provide full clinical study reports with acceptance criteria and detailed performance metrics as one might find for a novel or high-risk device. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing performed to show compliance with electrical safety and electromagnetic compatibility standards, and comparison to predicate devices, rather than a clinical trial evaluating pain relief efficacy with specific performance targets.
1. Table of Acceptance Criteria and Reported Device Performance
For this device (a TENS unit), "acceptance criteria" are primarily established by compliance with recognized medical device standards for electrical safety, electromagnetic compatibility, and specific requirements for nerve and muscle stimulators. The "reported device performance" refers to the measurements taken during these non-clinical tests and the comparison of key technical characteristics with predicate devices.
| Parameter/Acceptance Criteria | Reported Device Performance (Prospera OTC TENS) | Basis for Acceptance (Standard/Predicate Comparison) |
|---|---|---|
| Electrical Safety (IEC 60601-1) | Compliance confirmed. | Demonstrated by non-clinical testing against IEC 60601-1. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliance confirmed. | Demonstrated by non-clinical testing against IEC 60601-1-2. |
| Safety of Nerve & Muscle Stimulators (IEC 60601-2-10) | Compliance confirmed. | Demonstrated by non-clinical testing against IEC 60601-2-10. |
| Patient Leakage Current (Normal Condition) | PL009: 1.8 µA; PL029: 2.0 µA | Within limits of recognized standards and comparable to predicate devices (K102598: 2.0 µA). |
| Patient Leakage Current (Single Fault Condition) | PL009: 3.3 µA; PL029: 3.0 µA | Within limits of recognized standards and comparable to predicate devices (K102598: 4.2 µA). |
| Average DC Current through Electrodes (device on but no pulses) | 0 µA for all models. | Meets expectation for TENS devices to prevent continuous DC current. Comparable to predicate devices (0 µA). |
| General Construction and Materials | Enclosure: ABS | Comparable to predicate devices (ABS, silicone). |
| Software Verification | Carried out according to FDA guidance. | Compliance with FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices. |
| Electrodes Safety Requirements | Meet safety requirements. | Mentioned as compliant, specific standard not detailed in summary. |
| Intended Use & Operational Principle | "Temporary relief of pain associated with sore and aching muscles..." | Substantially equivalent to predicate devices with similar indications and operational principles (generating electrical pulses through electrodes to activate nerves for pain relief). |
| Technical Characteristics (e.g., Output Voltage, Current, Pulse Duration, Frequency) | Values presented in Tables B and C (e.g., Max Output Voltage at 500Ω: PL009: 12.8V, PL029: 49.6V; Pulse Duration: PL009: 120-6800 µSec, PL029: 100-200 µSec) | These values are compared to predicate devices (e.g., K102598: Max Output Voltage at 500Ω 62.4V, Pulse Duration 16.3-781mS). The argument is for substantial equivalence despite numerical differences, based on the overall effect and safety profile being similar. The summary states "The design differences... are insignificant and do neither affect the intended use, nor alter the operational principle." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a "test set" in the context of clinical data. For non-clinical (engineering/bench) testing, the sample size typically involves a small number of devices (often 1-3 units) tested against standards. The document does not specify the number of devices tested for compliance with the enumerated standards.
- Data Provenance: The data is generated from non-clinical tests performed on the subject device. This refers to bench testing in a laboratory setting to evaluate electrical safety, EMC, and performance characteristics. There is no mention of country of origin for the non-clinical test data, but it would typically be conducted by a certified testing lab. The study is not a retrospective or prospective clinical study but rather a technical verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this 510(k) submission.
- Nature of the Device: The Prospera OTC TENS Electronic Pulse Massager is a hardware device for pain relief, and its approval relies on demonstrating electrical safety, functional performance, and substantial equivalence to existing predicate devices, not on the output of an algorithm or diagnosis by experts.
- "Ground Truth": For this type of device, "ground truth" relates to the objective measurements of electrical parameters, safety compliance with standards, and functional specifications, not expert consensus on medical diagnoses or interpretations. These are typically established by objective physical measurements and adherence to engineering standards.
4. Adjudication Method for the Test Set
This information is not applicable to this 510(k) submission. Adjudication methods like 2+1 or 3+1 are used in clinical trials, especially when evaluating subjective endpoints or interpretations (e.g., radiological reads), to resolve discrepancies or ensure consistency in expert assessment. This submission relies on objective physical measurements and comparisons to predicate device specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary.
- Device Type: This is a Transcutaneous Electrical Nerve Stimulator (TENS), which is a direct-to-patient therapy device. It does not involve human readers interpreting output or an AI component that assists human readers in diagnosis or treatment planning.
- Purpose of 510(k): The 510(k) pathway focuses on demonstrating substantial equivalence, primarily through non-clinical testing for devices like TENS units. Clinical studies of efficacy (e.g., "how much human readers improve with AI vs without AI assistance") are typically not required for such devices unless there are significant technological differences or new indications for use that cannot be supported by equivalence.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
No, a standalone "algorithm only" performance study was not done or reported in this 510(k) summary.
- Nature of the Device: The Prospera OTC TENS is a hardware device with embedded software for controlling its electrical pulses and modes. It is not an "algorithm" in the sense of a diagnostic or predictive AI tool, and its function is not meant to be separated from the human user's interaction (e.g., selecting modes and intensity) for pain relief. Software verification was indeed performed, but this is to ensure the control software functions correctly and safely, not to evaluate its performance as a standalone interpretative algorithm.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Compliance with recognized electrical safety and EMC standards: This involves objective measurements against established thresholds defined in standards like IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10.
- Comparison to predicate device specifications: The technical characteristics (e.g., voltage, current, frequency, pulse duration) of the subject device are measured and compared to those of legally marketed predicate devices to establish substantial equivalence.
- Functional verification: Ensuring that the device operates as described (e.g., selection of massage styles, intensity, timer function).
There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this particular 510(k) submission because it's a TENS device seeking approval via substantial equivalence based on technical and safety characteristics.
8. Sample Size for the Training Set
This information is not applicable to this 510(k) submission.
- No AI/Machine Learning Training: The device does not employ machine learning or AI models that require a "training set." The embedded software controls the device's pre-programmed electrical pulse patterns and operational modes.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for an AI/ML model for this device. The "ground truth" for the device's functionality is its design specifications and compliance with established engineering and medical device safety standards.
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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:
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| 510(k) No. | Classification | FDA Dated | Model | Manufacturer |
|---|---|---|---|---|
| K102598 | NUH21 CFR §882.5890NGX21 CFR §882.5850OTC | 05/13/2011 | JQ-5C | Hi-Dow International, Inc. |
| K060846 | NUH21 CFR §882.5890NGX21 CFR §882.5850OTC | 12/03/2007 | T1040 | Endurance Therapeutics |
| K112392 | NUH21 CFR §882.5890OTC | 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 bothTranscutaneous Electrical NerveStimulator (TENS) and PoweredMuscle Stimulator (PMS) qualities inone device. Double channels thateffectively transfers user's desiredchoice of programmed electrical pulsesdirectly through electrode adhesivepads to the suggested area of the bodywhere the electrodes are placed,causing minimal muscle contractions.There are 6 modes of operation. | Temporary relief of painassociated with sore and achingmuscles in the shoulder, waist,back, neck, upper extremities(arm), and lower extremities (leg)due to strain from exercise ornormal household work activities. |
| K060846 | Pre-programmed electrical pulses aretransferred directly through electrodeadhesive pads to the suggested areaof the body where the electrodes areplaced, causing minimal musclecontractions. | Temporary relief of painassociated with sore and achingmuscles in the lower back due tostrain from exercise or normalhousehold and work activities. |
| K112392 | The stimulator can generate smallpulses of electrical current. Deliveredthese pulses pass through the skin andactivated underlying nerves. | Temporary relief of painassociated with sore and achingmuscles in the lower back as wellas upper and lower extremities(arm and/or leg) due to strain fromexercise or normal household andwork activities. |
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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.
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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.
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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.
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| Parameter | Your Device | Predicate | ||||
|---|---|---|---|---|---|---|
| 510(k) Number | K122744 | K122744 | K122744 | K102598 | K112392 | K060846 |
| Device Name and ModelManufacturer | PL009Prospera | PL009Prospera | PL029Prospera | JQ-5CHi-Dowinternational Inc | PP907HIVOXBIOTEK INC | T1040EnduranceTherapeutics |
| Power Source(s) | 6V BatteryBattery Supply N/A | 6V BatteryBattery Supply N/A | 3V BatteryBattery Supply N/A | 3.7V LithiumBattery Supply N/A | 3V BatteryBattery Supply | 4.5V BatteryBattery 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 whendevice 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 OutputChannels: | 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:
:
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K122744, 510(K) SUMMARY, TABLE B: PL009 & PL 009A'S COMPARISON WITH PREDICATE DEVICES
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| Parameter | PL009K122744 | PL009AK122744 | JQ-5CK102598 | PP909K112392 | PP907K112392 | PP904K112392 | T1040K060846 | |
|---|---|---|---|---|---|---|---|---|
| Waveform | Monophasic | Monophasic | Monophasic | Symmetricalbiphasic | Symmetricalbiphasic | Symmetricalbiphasic | 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) at500Ω | 18000 µC | 18000 µC | N/A | 0.3200 | 1.1008 | 0.2304 | 4.07 | |
| Maximum charge (µC) at500Ω | 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 powerdensity (W/cm²) at 500Ω | 0.23 W/cm² | 0.23 W/cm² | 2.72 | 0.078 | 0.232 | 0.163 | 5.35 (mW/cm²) | |
| BurstMode | (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) | Potentiometerswitch | Potentiometerswitch | N/A | 120 | 120 | 120 | N/A | |
| OFF time (sec) | Potentiometerswitch | Potentiometerswitch | N/A | 0 | 0 | 0 | N/A | |
| Additional features | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
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K122744, 510(K) SUMMARY, TABLE C: PL029'S COMPARISON WITH PREDICATE DEVICES
| Parameters | PL029K122744Monophasic | JQ-5CK102598Monophasic | PP909K112392Symmetrical biphasic | PP907K112392Symmetrical biphasic | PP904K112392Symmetrical biphasic | T1040K060846Biphasic | |
|---|---|---|---|---|---|---|---|
| WaveformShape | 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) | |
| BurstMode | 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 |
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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
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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
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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
§ 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).