(267 days)
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No
The description details a standard TENS device with pre-programmed modes and manual adjustments. There is no mention of adaptive learning, data analysis for personalized treatment, or any other characteristic typically associated with AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use for pain relief," which is a therapeutic purpose.
No.
The device is described as an electrical nerve stimulator indicated for pain relief, not for diagnosing medical conditions.
No
The device description explicitly details hardware components such as an electronic stimulatory module, battery, lead wires, electrodes, display screen, keys, and an outlet socket. It is a physical device that delivers electrical current.
Based on the provided text, the Jiajian® TENS device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "pain relief by applying an electrical current to electrodes on a patient's skin to treat pain." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details how the device works by sending electrical current through electrodes on the skin to nerves and muscles. This is consistent with a therapeutic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens from the human body to provide information for diagnostic purposes. The Jiajian® TENS device directly interacts with the patient's body for treatment, not for diagnosis.
N/A
Intended Use / Indications for Use
Jiajian® TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post surgical and post traumatic pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
Jiajian® TENS, is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin.
It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires and 9 volt type 6F22 battery.
When using this device, the physician should select and use 510(k) cleared electrodes. The area of electrodes must be larger than 8cm2.
The electronic stimulatory module has the operating elements of (1) Display screen, 2 Menu keys, 3 Modification keys, 4 On/Off key, 5 Battery compartment and (6) Outlet socket.
The display screen can show (a) battery power, (b) selected program, (c) lasting time or left time of a program, (d) current intensity for each channel, (e) program phase and (f) locking state.
The menu key "P" is for selecting standard program or user-program, and for locking; the menu key "E" is for editing program when the device is not being locked.
The modification key "3A" and "3B" are for intensity level adjustment during stimulation.
The outlet socket is used to connect skin electrodes by lead wires.
The device has 12 selectable programs, which can be grouped into 4 output modes, i.e. Normal mode (P1, P2, P3, P4, P5, P6), Burst mode (P7, P12), Rate & width modulation (P8), and Intensity modulation (P9, P10, P11).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The new device has passed testing according to the safety standards:
- IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995;
- IEC 60601-2-10 1987/Amendment 1 2001, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators; and
- IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests
The conclusion drawn from the safety testing is that the new device is substantially equivalent to the predicate device. Furthermore, the new device complies with the recognized standards and performs its intended tasks as well as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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).
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§ 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).
0
Wuxi Jiajian Medical Instrument Co., Ltd Qinghong Rd., Ehu Town, Xishan District, Wuxi, China Phone: 86 510-88745788 | Fax: 86 510-88746629 | URL: http://www. jjmed.cn
ILA (/an a
Section 5 510(k) Summary [As required by 21 CFR 807.92]
[As required by 21 CFR 807.92
| 1. Submission Information: | |
|---|---|
| 510(k) Number: | K112288 |
| Date: | March 15th, 2012 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |
| Qinghong Rd., Ehu Town, Xishan District, Wuxi, China 214116 | |
| Contactor: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add.: Room 1706 Yuesha, No. 128 Songle Rd., Songjiang, Shanghai, China 201600 | |
| E-mail: doris_d@126.com | |
| Tel: 86 21-31261348 | |
| Fax: 86 21-37824346 | |
- Device Description: Proprietary Name: Common Name: Classification Name: Regulation Number: Product Code: Device Class: Review Panel: Device Description:
Jiajian® TENS TENS (Transcutaneous Electrical Nerve Stimulator) Transcutaneous electrical nerve stimulator for pain relief 882.5890 GZJ II Neurology
Jiajian® TENS, is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin.
It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires and 9 volt type 6F22 battery.
When using this device, the physician should select and use 510(k) cleared electrodes. The area of electrodes must be larger than 8cm2.
The electronic stimulatory module has the operating elements of (1) Display screen, 2 Menu keys, 3 Modification keys, 4 On/Off key, 5 Battery compartment and (6) Outlet socket.
The display screen can show (a) battery power, (b) selected program, (c) lasting time or left time of a program, (d) current intensity for each channel, (e) program phase and (f) locking state.
The menu key "P" is for selecting standard program or user-program, and for locking; the menu key "E" is for editing program when the device is not being locked.
The modification key "3A" and "3B" are for intensity level adjustment during stimulation.
The outlet socket is used to connect skin electrodes by lead wires.
l
1
Wuxi Jiajian Medical Instrument Co., Ltd na (Juan a Qinghong Rd., Ehu Town, Xishan District, Wuxi, China Phone: 86 510-88745788 | Fax: 86 510-88746629 | URL: http://www.jjmed.cn The device has 12 selectable programs, which can be grouped into 4 output modes, i.e. Normal mode (P1, P2, P3, P4, P5, P6), Burst mode (P7, P12), Rate & width modulation (P8), and Intensity modulation (P9, P10, P11). Jiajian® TENS is an electrical nerve stimulator indicated for use for pain relief Indications for use: by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post surgical and post traumatic pain.
3. Substantial Equivalence to Predicate device:
Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) submission.
| Parameters | New Device | Predicate Device | ||
|---|---|---|---|---|
| 1. | 510(k) Number: | K112288 | K071951 | |
| 2. | Device Name | Jiajian® TENS | TENS, Model EV-804 | |
| 3. | Manufacturer | Wuxi Jiajian Medical | ||
| Instrument Co., Ltd | Everyway Medical Instruments | |||
| Co., Ltd | ||||
| 4. | Accessories | Electrode cables and batteries | Electrodes, gel, electrode | |
| cables and batteries | ||||
| 5. | Intended use | For symptomatic relief of | ||
| chronic intractable pain and | ||||
| adjunctive treatment in the | ||||
| management of post surgical | ||||
| and post traumatic pain. | For symptomatic relief and | |||
| management of chronic | ||||
| intractable pain, adjunctive | ||||
| treatment in the management | ||||
| of post surgical and post | ||||
| traumatic pain | ||||
| 6. | Power Source(s) | 9V Battery type 6F22 | 9V Battery type 6F22 | |
| - Method of Line Current Isolation | N/A | N/A | ||
| - Patient Leakage Current | ||||
| - Normal Condition (μA) | 2μA | N/A | ||
| - Single Fault Condition (μA) | N/A | N/A | ||
| 7. | Average DC current through electrodes | |||
| when device is on but no pulses are being | ||||
| applied (μA) |