Stimulation System (PA series, PR series, S series and Q series)
Device Facts
| Record ID | K232786 |
|---|---|
| Device Name | Stimulation System (PA series, PR series, S series and Q series) |
| Applicant | Edan Instruments, Inc. |
| Product Code | IPF · Physical Medicine |
| Decision Date | May 16, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications 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: 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. 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.
Device Story
Stimulation System (PA, PR, Q, S series) comprises neuromuscular electrical stimulators and TENS devices. Devices deliver biphasic symmetrical rectangular electrical pulses to patients via electrodes. PA/PR series used in clinics/hospitals; S/Q series used in clinics, hospitals, and home environments. Operated under medical supervision. Devices feature microprocessor control, automatic overload/no-load trips, and patient override stop buttons. Output parameters (frequency, pulse duration, intensity) are adjustable. Healthcare providers use device to treat muscle conditions or manage pain; output affects muscle contraction or nerve signaling to provide therapeutic benefit. Devices are powered by AC or internal Lithium-ion batteries.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical safety (ANSI AAMI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing per IEC 60601-2-10 and IEC 60601-2-40. Biocompatibility evaluated per ISO 10993-1. Software verification and validation performed per FDA guidance.
Technological Characteristics
Materials: Injection molded ABS plastic. Energy: AC or Lithium-ion battery (14.4V or 3.7V). Output: Biphasic symmetrical rectangular waveforms; regulated current. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-2-40, IEC 60601-1-11. Software: Microprocessor-controlled with automatic safety trips (overload, no-load, shut-off).
Indications for Use
Indicated for adults requiring neuromuscular electrical stimulation for muscle spasm relaxation, disuse atrophy prevention, local blood circulation improvement, post-surgical venous thrombosis prevention, range of motion maintenance, or muscle re-education. S&Q series additionally indicated for symptomatic relief of chronic intractable pain and adjunctive management of post-surgical or post-traumatic acute pain.
Regulatory Classification
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.
Predicate Devices
- STIWELL med4 (K080950)
Submission Summary (Full Text)
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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
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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
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# 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)
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# 510(K) Summary Prepared in accordance with the content and format regulatory Requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc.<br>#15 Jinhui Road, Jinsha Community,<br>Kengzi Sub-District, Pingshan District,<br>Shenzhen, 518122 P.R.China.<br>Tel: +86(0755) 26858736<br>Fax: +86(0755) 26882223 | | | | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Contact person: | Liu Yongying | | | | | | |
| Preparing date: | April 29, 2024 | | | | | | |
| 2. Device name and<br>classification: | Trade Name: Stimulation System<br>Common/Usual Name: PA series, PR series, Q series, S series<br>Model:<br>PA series: PA4 Pro; PA4; PA36; PA38;<br>PR series: PR4 Pro; PR4; PR36; PR38;<br>Q series: Q3; Q9; Q10; Q12;<br>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<br>K080950 (Predicate device). | | | | | | |
| 4. Device Description: | Subject device have four series, which are PA series, PR series, Q series and<br>S series. These four series are all electrical stimulating devices. | | | | | | |
| 5. Indication for Use | PA&PR series:<br>The PA&PR series are a neuromuscular electrical stimulator indicated for use<br>under medical supervision for adjunctive therapy in the treatment of medical<br>diseases and conditions.<br>As a powered muscle stimulator, PA&PR series are indicated for the following<br>conditions: | | | | | | |
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- · 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
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#### 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 | < Predicate Device > | < Subject Device > | Comparison Result |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | STIWELL med4 | PA&PR series | |
| Manufacturer<br>/K# | K080950 | Current Submission | — |
| Indication for use | The STIWELL med4 is a neuromuscular electronic<br>stimulator indicated for use under medical<br>supervision for adjunctive therapy in the treatment<br>of medical diseases and conditions.<br>As a powered muscle stimulator, STIWELL<br>med4 is indicated for the following conditions:<br>• Relaxation of muscle spasms,<br>• Prevention or retardation of disuse atrophy,<br>• Increasing local blood circulation,<br>• Immediate post-surgical stimulation of calf<br>muscles to prevent venous thrombosis,<br>• Maintaining or increasing range of motion,<br>• Muscle re-education. | The PA&PR series are a neuromuscular electronic<br>stimulator indicated for use under medical<br>supervision for adjunctive therapy in the treatment<br>of medical diseases and conditions.<br>As a powered muscle stimulator, PA&PR series<br>are indicated for the following conditions:<br>• Relaxation of muscle spasms,<br>• Prevention or retardation of disuse atrophy,<br>• Increasing local blood circulation,<br>• Immediate post-surgical stimulation of calf<br>muscles to prevent venous thrombosis,<br>• Maintaining or increasing range of motion,<br>• Muscle re-education. | Similar,<br>The<br>indications<br>for use of<br>the targeted<br>device is<br>within that<br>of the<br>predicate<br>device |
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| As a transcutaneous electrical nerve stimulator<br>for pain relief, STIWELL med4 is indicated for the<br>following conditions:<br>• Symptomatic relief and management of chronic<br>(long-term), intractable pain,<br>• Adjunctive treatment in the management of<br>post-surgical pain and post traumatic acute pain. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| As a biofeedback device, STIWELL med4 is<br>indicated for:<br>• Biofeedback, relaxation, and muscle re-education. |
| As an external functional neuromuscular<br>stimulator, STIWELL med4 is indicated for the<br>following conditions:<br>- Helps to relearn voluntary motor functions of the<br>extremities. |
| As a non-implanted electrical continence device,<br>STIWELL med4 is indicated for the following<br>conditions:<br>• Acute and ongoing treatment of stress, urge or<br>mixed urinary incontinence and where the<br>following results may improve urinary control:<br>inhibition of the detrusor muscles through reflexive<br>mechanisms and strengthening of pelvic floor<br>muscles.<br>• Incontinence treatment for assessing EMG<br>activity of the pelvic floor and accessory muscles<br>such as abdominal and the gluteus muscles |
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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) | <100 μ A | <100μA | Same |
| Patient Leakage Current (single fault condition) | <100 μ A | <100μA | Same |
| Number of Output Modes | 4 | 3 | Different Note(2) |
| Number of Output Channels | 4 | 4 | Same |
| Synchronous or Alternating | Alternating | Alternating | Same |
| Method of channel isolation | Transformer, inductive couplers | Transformer | Different Note(3) |
| Regulated Current or Regulated Voltage | Regulated Current | Regulated Current | Same |
| Software/Firmware/Microprocessor Control | Yes | Yes | Same |
| Automatic Overload trip | Yes | Yes | Same |
| Automatic no-load trip | Yes | Yes | Same |
| Automatic Shut Off | Yes | Yes | Same |
| Patient override control | Yes(Stop Button) | Yes(Stop Button) | Same |
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| method | | | |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|-----------|
| Indicator display<br>-On/Off status<br>-Low battery<br>-Voltage/current level | Yes | Yes | Same |
| Compliance with<br>voluntary standards | IEC 60601-1;<br>IEC 60601-1-2;<br>IEC 60601-2-10;<br>IEC 60601-2-40; | IEC 60601-1;<br>IEC 60601-1-2;<br>IEC 60601-2-10;<br>IEC 60601-2-40; | Same |
| Compliance with 21<br>CFR 898 | YES | YES | Same |
| Dimensions | 175×95×30mm | 270mm*232mm*55mm | Different |
| Weight | 440g | ≤3 kg | Note(4) |
| Housing material<br>and Construction | Plastic (Injection Molded ABS) | Plastic (Injection Molded ABS) | Same |
## Note (1):
Although the "Power Source" and "Method of Line Current Isolation" are different from predicate device is compliant with IEC 62133 standard. Moreover, the Subject device is IEC 60601-1 compliant and has been tested for electrical safety. The difference between them does not raise different questions of safety and effectiveness of Subject device
# Note (2):
The "Number of Output Modes" of Subject device are covered by predicate device, the difference between them does not raise different questions of safety and effectiveness of Subject device.
# Note (3):
The "Method of chamel isolation" of Subject device is different from predicate device is IEC 60601-1 compliant and has been tested for electrical safety. Thus the different questions of safety and effectiveness of Subject device.
# Note (4):
Although "Weight" and "Dimensions" of Subject device are different from predicate devices, they all comply with IEC 60601-2-10 requirements, thus the difference between them different questions of safety and effectiveness of Subject device.
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| As a powered muscle stimulator (PMS) | | | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | < Predicate Device > | < Subject Device > | Compariso<br>n Result |
| Item | STIWELL med4 | PA&PR series | |
| Manufacturer<br>/K# | K080950 | Current Submission | / |
| Output specifications | | | |
| Waveform | Biphasic symmetrical | Biphasic symmetrical | Same |
| Shape | Rectangular | Rectangular | Same |
| Maximum output<br>Voltage(500Ω) | 50V | 50V | Same |
| Maximum output<br>current(500Ω) | 100mA | 100mA | Same |
| Maximum output<br>Voltage(2kΩ) | 115V | 145V | |
| Maximum output<br>current(2kΩ) | 58mA | 72.5mA | Similar |
| Maximum output<br>Voltage(10kΩ) | 125V | 150V | Note 1 PMS |
| Maximum output<br>current(10kΩ) | 14mA | 15mA | |
| Pulse duration | 50-400μs | 50-400μs | Same |
| Pulse frequency | 1-140Hz | 2-140Hz | Similar |
| For interferential<br>modes only:<br>-Beat Frequency (Hz) | N/A | N/A | Same |
| For multiphasic<br>waveforms only:<br>-Symmetrical phases? | N/A | N/A | Same |
| For multiphasic | N/A | N/A | Same |
| Traditional 510(k) of Stimulation System | | | |
| waveforms only:<br>-Phase Duration | | | |
| Net Charge(per pulse)<br>(500Ω) | 0μC | 0μC | Same |
| Maximum Phase<br>Charge (500Ω) | 40μC | 40μC | Same |
| Maximum current<br>density (500Ω) | 12.5mA/cm² | 12.5mA/cm² | Same |
| Maximum power<br>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 | < predicate Device ><br>STIWELL med4 | < Subject Device ><br>S&Q series | Comparison Result |
| Manufacturer<br>/K# | K080950 | Current Submission | — |
| Indication for use | The STIWELL med4 is a neuromuscular electronic<br>stimulator indicated for use under medical<br>supervision for adjunctive therapy in the treatment<br>of medical diseases and conditions.<br><br>As a powered muscle stimulator, STIWELL med4<br>is indicated for the following conditions:<br>• Relaxation of muscle spasms,<br>• Prevention or retardation of disuse atrophy,<br>• Increasing local blood circulation,<br>• Immediate post-surgical stimulation of calf<br>muscles to prevent venous thrombosis,<br>• Maintaining or increasing range of motion.<br>• Muscle re-education,<br><br>As a transcutaneous electrical nerve stimulator for<br>pain relief, STIWELL med4 is indicated for the<br>following conditions:<br>• Symptomatic relief and management of chronic | The S&Q series are a neuromuscular<br>electronic stimulator indicated for use<br>under medical supervision for<br>adjunctive therapy in the treatment of<br>medical diseases and conditions.<br><br>As a powered muscle stimulator, S&Q<br>series are indicated for the following<br>conditions:<br>• Relaxation of muscle spasms,<br>• Prevention or retardation of disuse<br>atrophy,<br>• Increasing local blood circulation,<br>• Immediate post-surgical<br>stimulation of calf muscles to prevent<br>venous thrombosis,<br>• Maintaining or increasing range of<br>motion.<br>• Muscle re-education, | Similar,<br>The indications<br>of the targeted device<br>is within that of the<br>predicate device |
| | • Adjunctive treatment in the management of<br>post-surgical pain and post traumatic acute pain. | As a transcutaneous electrical nerve<br>stimulator for pain relief, S&Q series<br>are indicated for the<br>following conditions: | |
| | As a biofeedback device, STIWELL med4 is<br>indicated for:…
