(248 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that both PA&PR series and S&Q series are for "adjunctive therapy in the treatment of medical diseases and conditions" and list several therapeutic indications such as "relaxation of muscle spasms," "prevention or retardation of disuse atrophy," and "symptomatic relief and management of chronic (long-term), intractable pain."
No
The provided text describes the devices as "neuromuscular electrical stimulator" and "powered muscle stimulator" for therapeutic purposes (e.g., relaxation of muscle spasms, pain relief), not for identifying or diagnosing medical conditions.
No
The device description explicitly states that the devices are "electrical stimulating devices," which are hardware components. The summary also mentions electrical safety, EMC, and biocompatibility testing, which are relevant to hardware devices.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications for both the PA&PR series and S&Q series clearly describe the devices as neuromuscular electrical stimulators and transcutaneous electrical nerve stimulators. Their purpose is to apply electrical stimulation to the body for therapeutic purposes (muscle stimulation, pain relief).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The device description confirms that these are "electrical stimulating devices."
- Lack of Mention of Biological Samples: There is no mention of the device interacting with or analyzing biological samples.
The information provided consistently points to these devices being external electrical stimulators used for physical therapy and pain management, not for analyzing samples in vitro.
N/A
Intended Use / Indications for Use
PA&PR series:
The PA&PR series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, PA&PR series are indicated for the following conditions:
- · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation,
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- · Maintaining or increasing range of motion,
- · Muscle re-education.
Environments of Use: Clinics, hospital. Patient population: Adults
S&Q series:
The S&O series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, S&Q series are indicated for the following conditions:
- · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation,
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- · Maintaining or increasing range of motion,
- · Muscle re-education.
As a transcutaneous electrical nerve stimulator for pain relief, S&Q series are indicated for the following conditions:
· Symptomatic relief and management of chronic (long-term), intractable pain,
- · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
Environments of Use: Clinics, hospital and home environments.
Patient population: Adults
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ
Device Description
Subject device have four series, which are PA series, PR series, Q series and S series. These four series are all electrical stimulating devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Environments of Use: Clinics, hospital. (for PA&PR series)
Environments of Use: Clinics, hospital and home environments. (for S&Q series)
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 data:
Electrical safety and electromagnetic compatibility (EMC)
Study Type: Conformity assessment
Electrical safety and electromagnetic compatibility (EMC) tests were conducted in accordance with:
- ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/R) 2012.
- IEC 60601-1-2 Edition 4.1 2020-09.
Performance testing-Bench
Study Type: Functional and system level testing
Performance testing was conducted in accordance with:
- IEC 60601-2-10 Edition 2.1 2016-04.
- IEC 60601-2-40 Edition 2.0 2016-08.
- IEC 60601-1-11 Edition 2.1 2020-07.
Key results: The subject device meets its accuracy specification and relevant consensus standards.
Biocompatibility testing
Study Type: Biocompatibility testing
Conducted in accordance with FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1.
Software Verification and Validation Testing
Study Type: Software verification and validation
Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Clinical data: Not applicable.
Overall Summary: The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device. The bench testing data and software verification demonstrate that subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 16, 2024
Edan Instruments, Inc. Tracy Yue Regulatory Affairs Engineer #15 Jinhui Road, Pingshan District Shenzhen, Shenzhen 518122 China
Re: K232786
Trade/Device Name: Stimulation System (PA series, S series and Q series) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: September 08, 2023 Received: September 11, 2023
Dear Tracy Yue:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
1
change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jitendra V. Virani -S
CDR Jitendra Virani, MS, MBA Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232786
Device Name
Stimulation System
Model: PA4 Pro: PA4: PA36: PR4 Pro: PR4: PR36; PR38: O3: O9: O10: 012: S6; S9: S10: S12:
Indications for Use (Describe)
PA&PR series:
The PA&PR series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, PA&PR series are indicated for the following conditions:
- · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation,
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- · Maintaining or increasing range of motion,
- · Muscle re-education.
Environments of Use: Clinics, hospital. Patient population: Adults
S&Q series:
The S&O series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, S&Q series are indicated for the following conditions:
- · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation,
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- · Maintaining or increasing range of motion,
- · Muscle re-education.
As a transcutaneous electrical nerve stimulator for pain relief, S&Q series are indicated for the following conditions:
· Symptomatic relief and management of chronic (long-term), intractable pain,
- · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
Environments of Use: Clinics, hospital and home environments.
Patient population: Adults
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.
3
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4
510(K) Summary Prepared in accordance with the content and format regulatory Requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community,
Kengzi Sub-District, Pingshan District,
Shenzhen, 518122 P.R.China.
Tel: +86(0755) 26858736
Fax: +86(0755) 26882223 | | | | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Contact person: | Liu Yongying | | | | | | |
| Preparing date: | April 29, 2024 | | | | | | |
| 2. Device name and
classification: | Trade Name: Stimulation System
Common/Usual Name: PA series, PR series, Q series, S series
Model:
PA series: PA4 Pro; PA4; PA36; PA38;
PR series: PR4 Pro; PR4; PR36; PR38;
Q series: Q3; Q9; Q10; Q12;
S series: S6; S9; S10; S12; | | | | | | |
| | Classification Name Product code 21 CFR 890.5850 Physical Medicine IPF 21 CFR 882.5890 Neurological GZJ | | | | | | |
| | Regulatory Class: Class II | | | | | | |
| 3. Predicate Device(s): | 1) Otto Bock Healthcare Product GmbH, STIWELL med4, cleared under
K080950 (Predicate device). | | | | | | |
| 4. Device Description: | Subject device have four series, which are PA series, PR series, Q series and
S series. These four series are all electrical stimulating devices. | | | | | | |
| 5. Indication for Use | PA&PR series:
The PA&PR series are a neuromuscular electrical stimulator indicated for use
under medical supervision for adjunctive therapy in the treatment of medical
diseases and conditions.
As a powered muscle stimulator, PA&PR series are indicated for the following
conditions: | | | | | | |
5
- · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- · Maintaining or increasing range of motion,
- Muscle re-education.
Environments of Use: Clinics, hospital. Patient population: Adults
S&Q series:
The S&Q series are a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, S&Q series are indicated for the following conditions:
- Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation,
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- · Maintaining or increasing range of motion,
- · Muscle re-education.
As a transcutaneous electrical nerve stimulator for pain relief, S&Q series are indicated for the following conditions:
- · Symptomatic relief and management of chronic (long-term), intractable pain,
• Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
Environments of Use: Clinics, hospital and home environments. Patient population: Adults
6
6. Predicate Device Comparison
Comparison to the predicate devices, the subject device has the same intended use, similar performance effectiveness, the different technological characteristics of Subject device dose not raise different questions of safety and effectiveness. The summary is as following tables:
Subject device (PA&PR series)compares with predicate device
The following tabulation indicates the detailed differences between the subject device (PA&PR series) and the predicate device, we use the maximum configurations to compare with predicate device, and it can cover all other models.
| Item | Comparison Result | ||
|---|---|---|---|
| STIWELL med4 | PA&PR series | ||
| Manufacturer | |||
| /K# | K080950 | Current Submission | — |
| Indication for use | The STIWELL med4 is a neuromuscular electronic | ||
| stimulator indicated for use under medical | |||
| supervision for adjunctive therapy in the treatment | |||
| of medical diseases and conditions. | |||
| As a powered muscle stimulator, STIWELL | |||
| med4 is indicated for the following conditions: | |||
| • Relaxation of muscle spasms, | |||
| • Prevention or retardation of disuse atrophy, | |||
| • Increasing local blood circulation, | |||
| • Immediate post-surgical stimulation of calf | |||
| muscles to prevent venous thrombosis, | |||
| • Maintaining or increasing range of motion, | |||
| • Muscle re-education. | The PA&PR series are a neuromuscular electronic | ||
| stimulator indicated for use under medical | |||
| supervision for adjunctive therapy in the treatment | |||
| of medical diseases and conditions. | |||
| As a powered muscle stimulator, PA&PR series | |||
| are indicated for the following conditions: | |||
| • Relaxation of muscle spasms, | |||
| • Prevention or retardation of disuse atrophy, | |||
| • Increasing local blood circulation, | |||
| • Immediate post-surgical stimulation of calf | |||
| muscles to prevent venous thrombosis, | |||
| • Maintaining or increasing range of motion, | |||
| • Muscle re-education. | Similar, | ||
| The | |||
| indications | |||
| for use of | |||
| the targeted | |||
| device is | |||
| within that | |||
| of the | |||
| predicate | |||
| device |
7
| As a transcutaneous electrical nerve stimulator
for pain relief, STIWELL med4 is indicated for the
following conditions:
• Symptomatic relief and management of chronic
(long-term), intractable pain,
• Adjunctive treatment in the management of
| post-surgical pain and post traumatic acute pain. |
|---|
| As a biofeedback device, STIWELL med4 is |
| indicated for: |
| • Biofeedback, relaxation, and muscle re-education. |
| As an external functional neuromuscular |
| stimulator, STIWELL med4 is indicated for the |
| following conditions: |
- Helps to relearn voluntary motor functions of the
extremities. |
| As a non-implanted electrical continence device,
STIWELL med4 is indicated for the following
conditions:
• Acute and ongoing treatment of stress, urge or
mixed urinary incontinence and where the
following results may improve urinary control:
inhibition of the detrusor muscles through reflexive
mechanisms and strengthening of pelvic floor
muscles.
• Incontinence treatment for assessing EMG
activity of the pelvic floor and accessory muscles
such as abdominal and the gluteus muscles |
8
Traditional 510(k) of Stimulation System
| Product codes | IPF, GZJ, HCC, GZI, KPI | IPF | Similar |
|---|---|---|---|
| Environment of Use | Clinics, hospital and home environments | Clinics, hospital | Similar |
| Patient population | Adults | Adults | Same |
| Power Source | Battery Pack Li-Ion 11.1 V | AC or Lithium-ion Battery 14.4V | Different |
| Method of Line Current Isolation | Medical Class II Power Adapter | Medical Class I Power Adapter | Note(1) |
| Patient Leakage Current (normal condition) | Compariso | ||
| n Result | |||
| Item | STIWELL med4 | PA&PR series | |
| Manufacturer | |||
| /K# | K080950 | Current Submission | / |
| Output specifications | |||
| Waveform | Biphasic symmetrical | Biphasic symmetrical | Same |
| Shape | Rectangular | Rectangular | Same |
| Maximum output | |||
| Voltage(500Ω) | 50V | 50V | Same |
| Maximum output | |||
| current(500Ω) | 100mA | 100mA | Same |
| Maximum output | |||
| Voltage(2kΩ) | 115V | 145V | |
| Maximum output | |||
| current(2kΩ) | 58mA | 72.5mA | Similar |
| Maximum output | |||
| Voltage(10kΩ) | 125V | 150V | Note 1 PMS |
| Maximum output | |||
| current(10kΩ) | 14mA | 15mA | |
| Pulse duration | 50-400μs | 50-400μs | Same |
| Pulse frequency | 1-140Hz | 2-140Hz | Similar |
| For interferential | |||
| modes only: | |||
| -Beat Frequency (Hz) | N/A | N/A | Same |
| For multiphasic | |||
| waveforms only: | |||
| -Symmetrical phases? | N/A | N/A | Same |
| For multiphasic | N/A | N/A | Same |
| Traditional 510(k) of Stimulation System | |||
| waveforms only: | |||
| -Phase Duration | |||
| Net Charge(per pulse) | |||
| (500Ω) | 0μC | 0μC | Same |
| Maximum Phase | |||
| Charge (500Ω) | 40μC | 40μC | Same |
| Maximum current | |||
| density (500Ω) | 12.5mA/cm² | 12.5mA/cm² | Same |
| Maximum power | |||
| density (500Ω) | 7.9mW/cm² | 7.9mW/cm² | Same |
| Burst Mode | N/A | N/A | Same |
| ON Time | 1 - 20 s | 1 - 20 s | Same |
| OFF Time | 1 - 50 s | 1 - 20 s | Different |
| Treatment Time range | 2-120min | 1-60min, adjustable | Note2 PMS |
| Item | |||
| STIWELL med4 | |||
| S&Q series | Comparison Result | ||
| Manufacturer | |||
| /K# | K080950 | Current Submission | — |
| Indication for use | The STIWELL med4 is a neuromuscular electronic | ||
| stimulator indicated for use under medical | |||
| supervision for adjunctive therapy in the treatment | |||
| of medical diseases and conditions. |
As a powered muscle stimulator, STIWELL med4
is indicated for the following conditions:
• Relaxation of muscle spasms,
• Prevention or retardation of disuse atrophy,
• Increasing local blood circulation,
• Immediate post-surgical stimulation of calf
muscles to prevent venous thrombosis,
• Maintaining or increasing range of motion.
• Muscle re-education,
As a transcutaneous electrical nerve stimulator for
pain relief, STIWELL med4 is indicated for the
following conditions:
• Symptomatic relief and management of chronic | The S&Q series are a neuromuscular
electronic stimulator indicated for use
under medical supervision for
adjunctive therapy in the treatment of
medical diseases and conditions.
As a powered muscle stimulator, S&Q
series are indicated for the following
conditions:
• Relaxation of muscle spasms,
• Prevention or retardation of disuse
atrophy,
• Increasing local blood circulation,
• Immediate post-surgical
stimulation of calf muscles to prevent
venous thrombosis,
• Maintaining or increasing range of
motion.
• Muscle re-education, | Similar,
The indications
of the targeted device
is within that of the
predicate device |
| | • Adjunctive treatment in the management of
post-surgical pain and post traumatic acute pain. | As a transcutaneous electrical nerve
stimulator for pain relief, S&Q series
are indicated for the
following conditions: | |
| | As a biofeedback device, STIWELL med4 is
indicated for: | • Symptomatic relief and management
of chronic (long-term), intractable pain, | |
| | • Biofeedback, relaxation, and muscle re-education. | • Adjunctive treatment in the
management of post-surgical pain and
post traumatic acute pain. | |
| | As an external functional neuromuscular
stimulator, STIWELL med4 is indicated for the
following conditions: | | |
| | - Helps to relearn voluntary motor functions of the
extremities. | | |
| | | | |
| | As a non-implanted electrical continence device,
STIWELL med4 is indicated for the following
conditions: | | |
| | • Acute and ongoing treatment of stress, urge or
mixed urinary incontinence and where the
following results may improve urinary control:
inhibition of the detrusor muscles through reflexive
mechanisms and strengthening of pelvic floor
muscles. | | |
| | • Incontinence treatment for assessing EMG
activity of the pelvic floor and accessory muscles
such as abdominal and the gluteus muscles. | | |
| Product codes | IPF, GZJ, HCC, GZI, KPI | IPF, GZJ | Similar |
| | | Clinics, hospital and home | |
| Environment of Use | Clinics, hospital and home environments | environments | Same |
| Patient population | Adults | Adults | Same |
11
Note1 PMS:
At impedances of 2kΩ and 10kΩ, the Maximum output current is determined by the Maximum output Voltage of the subject device. The
Maximum output Voltage of the subject device is slightly higher than that of the maximum output current is also slightly higher than that of predicate device, but the maximum output current is within the range of 100mA.
Also, the working principle of the subject device is to electrically stimulate the human body through and performance is determined by the current density. The maximum current density of subject device is the same.
Therefore, the different technological characteristics of Subject device do not raise any different questions of safety and effectiveness.
Note2 PMS:
The "OFF Time" and "Treatment Time range" of Subject device are covered by the predicate device, thus the different technological characteristics of Subject device do not raise different questions of safety and effectiveness.
12
Subject device (S&Q series) compares with predicate devices
The following tabulation indicates the detailed comparison between the subject device(S&Q series) and the predicate device, we use the Maximum configuration to compare with predicate device, and it can cover all other models.
13
14
Traditional 510(k) of Stimulation System
| Power Source | Battery Pack Li-Ion 11.1 V | Lithium-ion Battery 3.7V | |
|---|---|---|---|
| Method of Line Current Isolation | Medical Class II Power Adapter | Internal Power Supply, Charging for class II | Different Note(1) |
| Patient Leakage Current (normal condition) | Comparison Result | ||
| STIWELL med4 | S&Q series | / | |
| Manufacturer /K# | K080950 | Current Submission | |
| Output specifications | |||
| Waveform | Biphasic symmetrical | Biphasic symmetrical | Same |
| Shape | Rectangular | Rectangular | |
| Maximum output | |||
| Voltage(500Ω) | 50V | 50V | Same |
| Maximum output | |||
| current(500Ω) | 100mA | 100mA | Same |
| Maximum output | |||
| Voltage(2kΩ) | 115V | 110V | |
| Maximum output | |||
| current(2kΩ) | 58mA | 55mA | Similar |
| Note 1 PMS | |||
| Maximum output | |||
| Voltage(10kΩ) | 125V | 115V | |
| Maximum output | |||
| current(10kΩ) | 14mA | 11mA | |
| Pulse duration | 50-400μs | 50-400μs | Same |
| Pulse frequency | 1-140Hz | 2-140Hz | Similar |
| For interferential | |||
| modes only: | |||
| -Beat Frequency (Hz) | N/A | N/A | Same |
| For multiphasic | |||
| waveforms only: | |||
| -Symmetrical phases? | N/A | N/A | Same |
| For multiphasic | |||
| waveforms only: | |||
| -Phase Duration | N/A | N/A | Same |
| Net Charge(per pulse) | 0μC | 0μC | Same |
| (500Ω) | |||
| Maximum Phase | |||
| Charge (500Ω) | 40μC | 40μC | Same |
| Maximum current | |||
| density (500Ω) | 12.5mA/cm² | 12.5mA/cm² | Same |
| Maximum power | |||
| density (500Ω) | 7.9mW/cm² | 7.9mW/cm² | Same |
| Burst Mode | N/A | N/A | Same |
| ON Time | 1 - 20 s | 1 - 20 s | Same |
| OFF Time | 1 - 50 s | 1 - 20 s | Different Note 2 PMS |
| Treatment Time range | 2-120min | ≤60min |
16
Traditional 510(k) of Stimulation System
17
Note1&2 PMS:
These parameters of Subject device are covered by predicate device, thus the different technological characteristics of Subject device do not raise different questions of safety and effectiveness.
As a transcutaneous electrical nerve stimulator(TENS)
| Item |
STIWELL med4 |
S&Q series | Comparison Result |
|-----------------------------------------|--------------------------------------|----------------------------------|-------------------------|
| Manufacturer
/K# | K080950 | Current Submission | / |
| Output specifications | | | |
| Waveform | Biphasic symmetrical | Biphasic symmetrical | Same |
| Shape | Rectangular | Rectangular | Same |
| Maximum output
Voltage(500Ω) | 50V | 50V | Same |
| Maximum output
current(500Ω) | 100mA | 100mA | Same |
| Maximum output
Voltage(2kΩ) | 115V | 110V | Similar
Note1 TENS |
| Maximum output
current(2kΩ) | 58mA | 55mA | |
| Maximum output
Voltage(10kΩ) | 125V | 115V | |
| Maximum output
current(10kΩ) | 14mA | 11mA | |
| Pulse duration | 150-200μs | 150-200μs | Same |
| Pulse frequency | 2-100Hz | 2-100Hz | Same |
| For interferential
modes only: | N/A | N/A | Same |
| -Beat Frequency (Hz) | | | |
| For multiphasic
waveforms only: | N/A | N/A | Same |
| -Symmetrical phases? | | | |
| For multiphasic
waveforms only: | N/A | N/A | Same |
| -Phase Duration | | | |
| Net Charge(per pulse)
(500Ω) | 0μC | 0μC | Same |
| Maximum Phase
Charge (500Ω) | 20μC | 20μC | Same |
| Maximum current
density (500Ω) | 12.5mA/cm² | 12.5mA/cm² | Same |
| Maximum power
density (500Ω) | 1.0mW/cm² | 1.0mW/cm² | Same |
| Burst Mode: Pulses per
burst | 8 | 8 | Same |
| Burst Mode: Bursts
per second | 2 | 2 | Same |
| Burst Mode: Burst
duration (seconds) | 100ms | 100ms | Same |
| Burst Mode: Duty Cycle | 20% | 20% | Same |
| ON Time | Continuous or Burst | Continuous or Burst | Same |
| OFF Time | N/A | N/A | Same |
| Treatment Time range | 10-120min |