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K Number
K231440
Device Name
Combo Electrotherapy Device
Manufacturer
Shenzhen Roundwhale Technology Co., Ltd.
Date Cleared
2023-11-03

(169 days)

Product Code
IPF,GZJ,LIH
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
K171978
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Model:R-C101W:

  • For TENS/IF/MIC mode
    1. Symptomatic relief of chronic intractable pain
    1. Post traumatic pain
    1. Post surgical pain
  • For EMS/RUSS mode
    1. Relaxation of muscle spasm.
    1. Increase of local blood flow circulation
    1. Prevention or retardation of disuse atrophy
    1. Muscle re-education
    1. Maintaining or increasing range of motion.
    1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

Model:R-C101A

  • For TENS/IF mode
    1. Symptomatic relief of chronic intractable pain.
    1. Post traumatic pain.
    1. Post surgical pain.
  • For EMS/RUSS mode
    1. Relaxation of muscle spasm.
    1. Increase of blood flow circulation.
    1. Prevention or retardation of disuse atrophy.
    1. Muscle re-education.
    1. Maintaining or increasing range of motion.
    1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

Model:R-C101B
For TENS/IF mode

    1. Symptomatic relief of chronic intractable pain
    1. Post traumatic pain
    1. Post surgical pain
  • For EMS/RUSS mode
    1. Relaxation of muscle spasm.
    1. Increase of local blood flow circulation
    1. Prevention or retardation of disuse atrophy
    1. Muscle re-education
    1. Maintaining or increasing range of motion.
    1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

Model:R-C101E
For IF mode

    1. Symptomatic relief of chronic intractable pain
    1. Post traumatic pain
    1. Post surgical pain
      For RUSS mode
    1. Relaxation of muscle spasm.
    1. Increase of local blood flow circulation
    1. Prevention or retardation of disuse atrophy
    1. Muscle re-education
    1. Maintaining or increasing range of motion.
    1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

Model:R-C101H
For TENS and IF mode

    1. Symptomatic relief of chronic intractable pain.
    1. Post traumatic pain.
    1. Post surgical pain.

Model:R-C101D
For TENS mode

    1. Symptomatic relief of chronic intractable pain
    1. Post traumatic pain
    1. Post surgical pain

Model:R-C101G
For TENS mode

    1. Symptomatic relief of chronic intractable pain.
    1. Post traumatic pain.
    1. Post surgical pain.
      For EMS mode
    1. Relaxation of muscle spasm.
    1. Increase of local blood flow circulation
    1. Prevention or retardation of disuse atrophy
    1. Muscle re-education
    1. Maintaining or increasing range of motion.
  1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis
Device Description

The Combo Electrotherapy Device (Models: R-C101W, R-C101B, R-C101E, R-C101H, R-C101D, and R-C101G) is a Transcutaneous Electrical Nerve Stimulator. The device features two independent output channels and four selfadhesive electrode gel pads. The stimulator sends a gentle electrical current to the underlying nerves and muscle groups via electrodes applied on the skin. Users can choose from pre-set programs or specify their own to suit their individual needs. All controls and indicators are controlled by software which also controls waveform characteristics. The 7 models have similar housing with a viewable LCD display and an accessible keypad. The LCD is located on the upper half of the rectangular face of the device above the keypad. It is used to display system information to the user. The device is battery-powered but can be connected to an external power supply its internal battery which is a non-user serviceable or accessible 3.7V D.C., Li-ion battery. There are only two external connections on the device - power input and electrode connector - with no connection to any other devices. The Battery Charger is not included in the package; however, users can choose adapters that meet IEC 60601-1 medical stardards.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a "Combo Electrotherapy Device." It establishes substantial equivalence to a predicate device, K171978. The document primarily focuses on non-clinical performance and safety data, as no clinical data was performed.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on demonstrating equivalence to the predicate device (K171978) in technical characteristics and compliance with relevant safety standards. The reported device performance is presented as a comparison to the predicate device.

Acceptance Criteria CategorySpecific Criteria (Implicitly based on Predicate Device)Reported Device Performance (New Device K231440)Discussion
Indications for UseSame indications as predicate: Symptomatic relief of chronic intractable pain, post-traumatic pain, post-surgical pain (TENS/IF/MIC); Relaxation of muscle spasm, increased local blood flow, prevention/retardation of disuse atrophy, muscle re-education, maintaining/increasing range of motion, immediate post-surgical stimulation to prevent venous thrombosis (EMS/RUSS).Primarily the same across all models (R-C101W, R-C101A, R-C101B, R-C101E, R-C101H, R-C101D, R-C101G), with some models having subsets of the modes. For example, R-C101E only has IF and RUSS modes for the specified indications.Same. The document states, "The proposed device has the same intended use... as the predicate device." While some models have fewer modes, the indications for the available modes are identical.
Power Source3.7V Li-ion Battery Charger output: 5.0V DC, 300mA3.7 V Li-ion battery Charger Output: 5V DC, 300mASame.
Patient Leakage CurrentNormal condition: 5 uA; Single fault condition: 5 uANormal condition: 5 uA; Single fault condition: 5 uASame.
Number of Output Channels22Same.
Channel IsolationBy enclosureBy enclosureSame.
Current/Voltage ControlConstant Current: Yes; Constant Voltage: NoConstant Current: Yes; Constant Voltage: NoSame.
Software/Firmware ControlYesYesSame.
Safety FeaturesAutomatic Overload Trip: Yes; Automatic Over Current Trip: Yes; Automatic No-Load Trip: Yes; Automatic Shut-off: Yes; Patient Override Control: NoAll "Yes" for trip/shut-off features, "No" for patient override control.Same.
Indicator DisplayOn/Off Status: Yes; Voltage/Current Level: Yes; Low Battery: YesAll "Yes".Same.
Waveform TypeBiphasic for TENS, EMS, Interferential, Russian; Monophasic for Microcurrent. Shapes are all Square.Bi-phase for all except MIC (Mono-phase). All shapes are Square.Same.
Max Output Voltage (V) ±20% (Various Loads)Ranges provided for Predicate (e.g., TENS 500Ω: 50V, 2kΩ: 102V)Ranges provided for New Device (e.g., TENS 500Ω: 45V, 2kΩ: 96V).Different, but the discussion notes these parameters passed IEC 60601-2-10 tests and do not exceed safety limits (calculated max current density and average power density). No new safety/effectiveness issues.
Max Output Current (mA) ±20% (Various Loads)Ranges provided for Predicate (e.g., TENS 500Ω: 100mA, 2kΩ: 51mA)Ranges provided for New Device (e.g., TENS 500Ω: 90mA, 2kΩ: 48mA).Different, but the discussion notes these parameters passed IEC 60601-2-10 tests and do not exceed safety limits (calculated max current density and average power density). No new safety/effectiveness issues.
Pulse Width RangeRanges provided for Predicate (e.g., TENS: 50-400uS; EMS: 200~400uS)Ranges provided for New Device (e.g., TENS/EMS: 50 to 450 μs; IF: 50µs/100µs; MIC: 2ms - 500ms; RUSS: 200μs).Different, but noted as minor and compliant with 60601-2-10, thus not raising safety/effectiveness issues.
Frequency RangeRanges provided for Predicate (e.g., TENS: 1150Hz; EMS: 1100Hz)Ranges provided for New Device (e.g., TENS/EMS: 2 to 150 Hz; IF Carrier F 5KHz/10KHz Beat F1Hz -200Hz; MIC: 0.1Hz - 150Hz; RUSS Carrier F 2.5KHz Burst F10Hz -70Hz).Different, but noted as minor and compliant with 60601-2-10, thus not raising safety/effectiveness issues.
Beat Frequency (IF)1-200Hz1-200HzSame.
Maximum Phase Charge (uC, 500Ω)TENS: 2.40; EMS: 2.40; IF: 0.79; MIC: 0.48; RUSS: 3.5TENS: 2.73; EMS: 2.73; IF: 0.75; MIC: 0.42; RUSS: 9Different, but stated to have passed IEC 60601-2-10 tests and safety limits (current density

§ 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).