(239 days)
No
The description mentions a microprocessor and pre-set programs, but there is no indication of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly "Not Found".
Yes
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for symptomatic relief of acute post-traumatic pain, acute post-surgical pain, and chronic intractable pain, which are therapeutic indications.
No
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for pain relief, not for diagnosing conditions.
No
The device description explicitly states it is a "Transcutaneous Electrical Nerve Stimulator (TENS)" that "delivers a gentle electrical pulse to the underlying nerve through the wires and electrode pads placed on the skin of users." This involves physical hardware components (the stimulator unit, wires, and electrodes) that deliver the therapy, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Electronic Pulse Massager is a Transcutaneous Electrical Nerve Stimulator (TENS). It works by delivering electrical pulses through electrode pads placed on the skin to relieve pain.
- Intended Use: The intended use is for the symptomatic relief of pain, not for analyzing biological specimens.
- Mechanism of Action: The device's mechanism of action is electrical stimulation applied externally, not the analysis of samples taken from the body.
The information provided consistently describes a device that interacts with the body externally for therapeutic purposes, which is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
Symptomatic relief of acute post traumatic pain, acute post surgical pain, and chronic intractable pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
The Electronic Pulse Massager, which includes Models PL009, PL009A, and PL029, is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. TENS can help to relieve the pain caused by trauma or continual strain, and is suitable to be used on the user's back, neck, shoulders, legs, arms, and feet. The proposed Electronic Pulse Massager, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the underlying nerve through the wires and electrode pads placed on the skin of users. According to the need of users, the pulse intensity can be adjustable on the front control panel of the massager. Both Models PL009 and PL009A have five automatic stimulation programs and three manual programs, while Massager PL029 contains five automatic stimulation programs and eight selectable programs. The only difference between Models PL009 and PL009A is the former has a "REPEAT" program function and the latter does not. All these programs as well as the pulse intensity and time remaining can be displayed on the liquid crystal display screen of both massagers.
PL009, PL009A, and PL029 Electronic Pulse Massagers consist of the following:
-
- Stimulation unit with the microprocessor-controlled integrated circuit, liquid crystal display, and ABS plastic shell included
-
- Four AAA batteries for PL009 and PL009A; two AAA batteries for PL029
-
- Two wires
-
- Four pieces electrode pads (FDA-cleared under 510(k) #K100117, manufactured by SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Back, neck, shoulders, legs, arms, and feet.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Electronic Pulse Massager, Models PL009, PL009A, and PL029 do not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical testing was performed in order to validate the design and to assure conformance with the following voluntary design standards:
- (a) EN55014-1: Electromagnetic compatibility-Requirements for household appliances, electric tools, and similar apparatus-Part 1: Emission-Product family standard
- (b) EN55014-2: Electromagnetic compatibility-Requirements for household appliances, electric tools, 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"
- (h) IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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510(k) Summary
JUL 2 7 2012
This 510(k) Summary is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Contact Details
Submitter: Prospera Corporation Address: 405 Boulder Ct, Ste 500, Pleasanton, CA 94566, USA Contact Person: Jane Ding Tel: 925-225-0888; Fax: 925-225-0660; Email: jane@prosperacorp.com Date of Submission: 11/28/2011
Address of the manufacturing facility: Shenzhen Jingkehui Electronic Co., Ltd. 3F, Building 1, B Area, Xifa Industrial Area, Yintian Village, Xixiang Town, Baoan District, Shenzhen, China
2. Proposed Device
Trade Name: Electronic Pulse Massager, Models PL009, PL009A, and PL029 Common Name: Transcutaneous electrical nerve stimulator Classification Name: Stimulator, Nerve, Transcutaneous, For Pain Relief Regulation Description: Transcutaneous electrical nerve stimulator for pain relief Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: GZJ Regulation Number: 21 CFR 882.5890 Device Class: II
3. Predicate device
Predicate Device: TENS 3000 Stimulator 510(k) Number: K102014 Manufacturer: Koalaty Products, Inc.
4. Description of Proposed Device
The Electronic Pulse Massager, which includes Models PL009, PL009A, and PL029, is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. TENS can help to relieve the pain caused by trauma or continual strain, and is suitable to be used on the user's back, neck, shoulders, legs, arms, and feet. The proposed Electronic Pulse Massager, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the underlying nerve through the wires and electrode pads placed on the skin of users. According to the need of users, the pulse intensity can be adjustable on the front control panel of the massager. Both Models PL009 and PL009A have five automatic stimulation programs and three manual programs, while Massager PL029 contains five automatic stimulation programs and eight selectable programs. The only difference between Models PL009 and PL009A is the former has a "REPEAT" program function and the latter does not. All these programs as well as the pulse intensity and time remaining can be displayed on the liquid crystal display screen of both massagers.
1
PL009, PL009A, and PL029 Electronic Pulse Massagers consist of the following:
-
- Stimulation unit with the microprocessor-controlled integrated circuit, liquid crystal display, and ABS plastic shell included
-
- Four AAA batteries for PL009 and PL009A; two AAA batteries for PL029
-
- Two wires
-
- Four pieces electrode pads (FDA-cleared under 510(k) #K100117, manufactured by SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.)
5. Intended Use Statement of Proposed Device
The proposed Electronic Pulse Massager, Models PL009, PL009A, and PL029, is intended for symptomatic relief of acute post traumatic pain, acute post surgical pain, and chronic intractable pain.
The proposed Electronic Pulse Massager, Models PL009, PL009A, and PL029, is intended for prescription use only.
6. Technological Characteristics
Both the proposed and predicate devices have the same intended use and fundamental technology. A side-by-side comparison of these two devices is included in the 510(k) submission, showing the proposed Electronic Pulse Massager, Models PL009, PL009A, and PL029, is substantially equivalent to the predicate device (Table 1, below).
| Table 1. Technological characteristic comparison between the proposed device and | |||||
|---|---|---|---|---|---|
| predicate device |
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| 1 | 510(k) Number | K102014 | |
| 2 | Device Name | Electronic Pulse Massager | |
| Models PL009, PL009A, | |||
| and PL029 | TENS 3000 Stimulator | ||
| 3 | Intended Use | Symptomatic relief of | |
| acute post traumatic pain, | |||
| acute post surgical pain, | |||
| and chronic intractable | |||
| pain | Symptomatic relief of | ||
| chronic intractable pain, | |||
| acute post traumatic | |||
| pain or acute post | |||
| surgical pain | |||
| 4 | Power Source | 6V Battery for PL009 and | |
| PL009A; 3V Battery for | |||
| PL029 | 9V Battery | ||
| 5 | Method of Line | ||
| Current Isolation | Battery Supply N/A | Battery Supply N/A | |
| 6 | Number of Output Channels | 2 | 2 |
| 7 | Method of Channel Isolation | By Enclosure | By Enclosure |
| 8 | Software/Firmware | ||
| /Microprocessor Control | Yes | Yes | |
| 9 | Automatic Overload Trip | No | No |
| 10 | Automatic Over Current Trip | No | No |
| 11 | Automatic No-Load Trip | No | No |
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| 12 | Automatic Shut Off | No | No |
|---|---|---|---|
| 13 | Patient Override Control | No | No |
| 14 | Indicator Display | Yes | Yes |
| 15 | Timer Range | 15 min, continue | 15 min, continue |
| 16 | Waveform | Biphasic or Monophasic | |
| Rectangular Pulse | Biphasic or Monophasic | ||
| Rectangular Pulse | |||
| 17 | Frequency | 2-60 Hz | 2-150 Hz |
| 18 | Compliance with Voluntary | ||
| Standards | EN55014-1, EN55014-2, | ||
| EN60335-1, EN60335-2, | |||
| EN62233, IEC60601-1, | |||
| IEC60601-1-2, IEC60601- | |||
| 2-10 | IEC60601-1, IEC60601- | ||
| 1-2, IEC60601-2-10 | |||
| 19 | Compliance with 21 CFR 898 | Yes | Yes |
| 20 | Weight | 150 grams for PL009 and | |
| PL009A; 125 grams for | |||
| PL029 | 115 grams | ||
| 21 | Dimensions (HxWxT) | 200x55x33mm for PL009 | |
| and PL009A | |||
| 203x63x13mm for PL029 | 95x65x23.5mm | ||
| 22 | Housing Materials & | ||
| Construction | Enclosure: ABS Plastic | Enclosure: ABS Plastic |
7. Non-Clinical Tests Performed for Determination of Substantial Equivalence
The Electronic Pulse Massager, Models PL009, PL009A, and PL029 do not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical testing was performed in order to validate the design and to assure conformance with the following voluntary design standards:
- (a) EN55014-1: Electromagnetic compatibility-Requirements for household appliances, electric tools, and similar apparatus-Part 1: Emission-Product family standard
- (b) EN55014-2: Electromagnetic compatibility-Requirements for household appliances, electric tools, 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"
- (h) IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators"
8. Conclusion
The Electronic Pulse Massager, Models PL009, PL009A, and PL029, has the same intended use and technological characteristics as the predicate device. The comparison of these devices
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demonstrates that the submitted models are as safe, as effective, and perform as well as the predicate device. Therefore, the Electronic Pulse Massager, Models PL009, PL009A, and PL029, is substantially equivalent to the predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 7 2012
Alcon Research, Ltd. % Ms. Jane Ding Chief Executive Officer 405 Boulder Court, Suite 500 Pleasanton, CA 94566
Re: K113544
Trade/Device Name: Electronic Pulse Massager, Models PL009, PL009A and PL029 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: GZJ Dated: June 21, 2012 Received: June 22, 2012
Dear Ms. Ding:
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
5
device-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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Deborah Fair
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K113544
Device Name: Electronic Pulse Massager, Models PL009, PL009A, and PL029
Indications for Use: Symptomatic relief of acute post traumatic pain, acute post surgical pain, and chronic intractable pain.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Foo DXS
(Division Sign Off) (Division Sign-Orr)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K113544
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