STIWELL MED4

K080950 · Otto Bock, Austria GmbH · IPF · Apr 2, 2009 · Physical Medicine

Device Facts

• Record ID: K080950
• Device Name: STIWELL MED4
• Applicant: Otto Bock, Austria GmbH
• Product Code: IPF · Physical Medicine
• Decision Date: Apr 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 the STIWELL med4 is indicated for the following conditions: - Relaxation of muscle spasm . - . Prevention or retardation of disuse atrophy - . Increasing local blood circulation - . Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis . - . Maintaining or increasing range of motion As a transcutaneous electrical nerve stimulator for pain relief the 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 the STIWELL med4 is indicated for the following conditions: - Biofeedback, relaxation and muscle re-education purposes As an external functional neuromuscular stimulator the STIWELL med4 is indicated for the following conditions: - Helps to relearn voluntary motor functions of the extremities As a nonimplanted electrical continence device the STIWELL med4 is indicated for the following conditions: - Acute and ongoing treatment of stress, urge or mixed uringry incontinence and where the . following results may improve urinary control: Inhibition of the detruser 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 the abdominal and the gluteus muscles

Device Story

STIWELL med4 is a battery-powered neuromuscular stimulator with four stimulation channels and two EMG measurement channels. Used in clinical or home settings under physician/therapist supervision. Device inputs include EMG signals from patient muscles; device processes these signals using AVR (Average Rectified Value) and delivers electrical stimulation via programmed modes. Physician/therapist adjusts therapy programs and monitors progress via device or PC-based statistics. Output provides muscle stimulation for therapeutic purposes, including incontinence treatment and motor function relearning. Patient can use stop button for override. Benefits include improved muscle control, pain relief, and urinary function.

Clinical Evidence

Bench testing only. No clinical data presented. Device performance verified through compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-10, and 21 CFR 898, alongside manufacturer-defined functional and safety tests including environmental and mechanical stress testing.

Technological Characteristics

Battery-powered (Li-Ion 11.1V) neuromuscular stimulator. 4 stimulation channels, 2 EMG input channels. Bipolar EMG detection (70-480Hz bandwidth, 3kHz sampling). Regulated current output; biphasic symmetrical waveform. Plastic housing. Connectivity via PC software for data retrieval. Microprocessor-controlled. Sterilization not applicable (external use). Complies with IEC 60601-1, 60601-1-2, 60601-2-10.

Indications for Use

Indicated for patients requiring adjunctive therapy for muscle spasm, disuse atrophy, blood circulation, muscle re-education, post-surgical venous thrombosis prevention, range of motion maintenance, chronic/post-surgical/post-traumatic pain management, biofeedback, motor function relearning, and treatment of stress, urge, or mixed urinary incontinence.

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

• Elpha Models II 500, II 1000, II 2000, II 3000 A (K032954)
• Myotrac Infinity Electrical Stimulator (K053434)
• Mentamove (K040849)
• Compex 2 (K940301)
• Elpha 4 Conti (K032988)
• Handmaster (K031900)

Submission Summary (Full Text)

{0}------------------------------------------------

K080950

Otto Bock®

APR - 2 2009

## QUALITY FOR L

# Summary of Safety and Effectiveness STIWELL med4

### Manufacturer: A

Otto Bock Healthcare Product GmbH Kaiserstrasse 39 1070 Vienna Austria

Telephone: [phone] Fax Number: [phone] Juergen Weiss Contact: Regulatory Affairs Manager

### B Contact:

Otto Bock Healthcare Product GmbH Kaiserstrasse 39 1070 Vienna Austria

[phone] Telephone: Fax Number: [phone] Contact: Juergen Weiss Regulatory Affairs Manager

### C Product Name/ Classification Name:

Common or Usual Name: Proprietary or Trade Name: Model Number:

Powered Muscle Stimulator STIWELL med4 900101S

| Class | Regulation No. | Device Classification Name | Product Code | Speciality |
|-------|----------------|---------------------------------------------------------------|--------------|------------------------------|
| II | 890.5850 | Stimulator, Muscle, Powered | IPF | Physical Medicine |
| II | 882.5890 | Stimulator, Nerve,<br>Transcutaneous, For Pain Relief | GZJ | Neurology |
| II | 882.5050 | Device, Biofeedback | HCC | Neurology |
| II | 882.5810 | Stimulator, Neuromuscular,<br>External Functional | GZI | Neurology |
| II | 876.5320 | Stimulator, Electrical, Non-<br>Implantable, For Incontinence | KPI | Gastroenterology/<br>Urology |

Otto Bock Healthcare Products GmbH

Koiserstraße 39 - 1070 Wien - Austria Telefox ([phone] - e-moil: [e-mail] · www.ottobock.at Kundenservice: Telefon [phone] · Teletax ([phone] HG WIEN FN 242378p · UID Nr.: ATU 57528204 · ARA-Nr.; 8864 · ERA-Nr.: 50411

Bonk Austria Creditanstalt Aktiergesellschaft, Filiale Westbahnstraße Switt Code: BKAUATWW BLZ 12 000, Konto-Nr. 09743146400 Erste Bonk, Kommerzcenter Wien West 2 Swift Code: GIBAATWW BLZ 20 111, Konto-Nr. 30001045517

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for Otto Bock. The logo is in a cursive font and is black. There is a registered trademark symbol to the right of the word Bock.

### D Predicate Devices:

| 510(k)<br>No. | Predicate Device | Manufacturer | Regulation<br>Number | Product<br>Code(s) | Clearance<br>Date |
|---------------|--------------------------------------------------------|----------------------------------------------------------------|----------------------|--------------------|-------------------|
| K032954 | Elpha Models II<br>500, II 1000, II<br>2000, II 3000 A | Danmeter A/S | 890.5850 | IPF, GZJ | 08/09/2004 |
| K053434 | Myotrac Infinity<br>Electrical Stimulator | Thought<br>Technology Ltd. | 876.5320 | KPI,<br>HCC, IPF | 03/15/2006 |
| K040849 | Mentamove | Cole &<br>Associates | 890.5850 | IPF, HCC | 10/01/2004 |
| K940301 | Compex 2 | Biodex Medical<br>Systems, Inc. | 890.5850 | IPF, GZJ | 12/28/1994 |
| K032988 | Elpha 4 Conti | Danmeter A/S | 876.5320 | KPI | 12/03/2003 |
| K031900 | Handmaster | Ness-<br>Neuromuscular<br>Electrical<br>Stimulation<br>Systems | 882.5810 | GZI | 08/08/2003 |

### E Description:

The STIWELL med4 is powered by rechargeable batteries. It has four stimulation channels and two EMG measurement channels.

The STIWELL med4 is intended for stationary use in a hospital as well as home use by the patient. The physician/therapist has the flexibility to adjust the programs and monitors the progress of the therapy. Statistics regarding the completed treatments can be retrieved from the STIWELL med4 and from the PC.

In order to gain a proper understanding of STIWELL med4, it is important to read the manual before beginning to use the STIWELL med4.

Otto Bock Healthcare Products GmbH Kaisarstraße 38 - 1070 Wien • Austria • Telefox ([phone] • e-mail: [e-mail] • www.attobock.cl Kundenservice: Telefon [phone] · Telefax ([phone] HG WIEN FN 242378p - UID-Nr.: ATU 57529204 · ARA-Nr.: 8864 · ERA-Nr.: 50411 Bank Austria Creditonstalt Aktiongesellschatt, Filicle Westbanstraße Swift Code: BKAUATWW BLZ 12 000, Konto-Nr. 09743146400 Erste Bonk, Kommerzcenter Wien West 2 Switt Code: GIBAATWW BLZ 20 111, Konto-Nr. 30001045517

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for Otto Bock. The logo is in a cursive font and is black. There is a registered trademark symbol to the right of the word "Bock".

### F Substantial Equivalence:

Powered Muscle Stimulator:

| Characteristics/ Specific,<br>Basic Unit Characteristics | New Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Characteristics/<br>Specifications<br>Basic Unit<br>Chrocteristics | New Device | Predicate<br>Device | New Device | Predicate<br>Device | New Device | Predicate<br>Device | New Device | Predicate<br>Device |
|-------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------|----------------------------------------------|----------------------------------------------|----------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------|------------------------------------|---------------------------------------------------|------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------|
| 510(k) Number | K080950 | K032954 | K053434 | K040849 | K940301 | Program | FES 1<br>Grasp/Release | Exercise Open | FES 2<br>Grasp/Release<br>(EMG) | Exercise Open | FES 3<br>Open/Close | Exercise | FES 4<br>Open/Close<br>(EMG) | Palmar Grasp |
| Manufacturer | Otto Bock | Dannmeler A/S | Thought Technology Ltd. | Mentamove North America, LCC | Comper SA | 510(k) Number | K080950 | K031900 | K080950 | K031900 | K080050 | K031900 | K080950 | K031900 |
| Device Name, Model | STIWELL mad4 | Elpha 113000 | Myotrac Infinity | Mentamove | Compex 2 | Manufacturer | Otto Bock | Ness | Otto Bock | Ness | Otto Bock | Ness | Otto Bock | Ness |
| Power Source(s) | Battery Pack Li-Ion 11,1V | Battery NMH or Alkaline 9V | Battery Pack NiMH rechargeable | Battery Pack NiMH rechargeable | Battery Pack NiMH 7,2 V | Device Name | STIWELL med4 | Handmaster | STIWELL med4 | Handmaster | STIWELL med4 | Handmaster | STIWELL med4 | Handmaster |
| Method of Line Current<br>Isolation | Medical Class II Power<br>Adapter - Mascot<br>(12,6VDC-15,1W) | N/A | Medical Class II Power<br>Adapter (6VDC-15W) | Battery Charger (6VDC-2,1W) | Battery Charger (11VDC-7,2W) | Power Source(s) | Battery Pack Li-<br>Ion 11,1V | Battery Pack Ni<br>Cd 9,6V | Battery Pack Li-<br>Ion 11,1V | Battery Pack Ni<br>Cd 9,6V | Battery Pack Li-<br>Ion 11,1V | Battery Pack Ni<br>Cd 9,6V | Battery Pack Li-<br>Ion 11,1V | Battery Pack Ni<br>Cd 9,6V |
| Patient Leakage Current<br>(normal condition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | Method of Line<br>Current Isolation | Medical Class II<br>Power Adapter | N/A | Medical Class II<br>Power Adapter | N/A | Medical Class II<br>Power Adapter | N/A | Medical Class II<br>Power Adapter | N/A |
| Patient Leakage Current<br>(single fault condition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | Leakage Current<br>(normal condition) | N/A (Battery) | N/A | N/A (Battery) | N/A | N/A (Battery) | N/A | N/A (Battery) | N/A |
| Number of Output Modes | 1 | 1 | 1 | 1 | 1 | Leakage Current<br>(single fault cond.) | N/A (Battery) | N/A | N/A (Battery) | N/A | N/A (Battery) | N/A | N/A (Battery) | N/A |
| Number of Output Channels | 4 | 2 | 2 | 2 | 4 | No. Output Mod. | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Number of EMG (input)<br>Channels | 2 | N/A | 2 | 1 | N/A | No. Output Chan | 3 | 2 | 3 | 2 | 3 | 2 | 5 | 5 |
| EMG sensitivity | N/A | N/A | <0.1μV | 1μV | N/A | Stimulated Muscl. | Wrist extensors<br>Finger flexors<br>Thumb flexor | Finger extensors<br>Thumb extensor | Wrist extensors<br>Finger flexors<br>Thumb flexor | Finger extensors<br>Thumb extensor | Finger/thumb<br>extensors<br>Finger flexors<br>Thumb flexor | Finger extensors<br>Thumb extensor<br>Finger flexors<br>Thumb flexor<br>Thenar muscle | Finger/thumb<br>extensors<br>Finger flexors<br>Thumb flexor | Finger extensors<br>Thumb extensor<br>Finger flexors<br>Thumb flexor<br>Thenar muscle |
| EMG Sampling Rate | 3kHz | N/A | 2.048kHz | Unknown | N/A | No. of EMG Chan. | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 |
| EMG detection (bipolar/<br>monopolar) | Bipolar | N/A | Bipolar | Bipolar | N/A | EMG sensitivity | N/A | N/A | 1μV | N/A | N/A | N/A | 1μV | 1μV |
| EMG range (μV) | 1-2000μV | N/A | 0-2000μV | 2-2000μV | N/A | EMG Sampl. Rate | N/A | N/A | 3kHz | N/A | N/A | N/A | 3kHz | 3kHz |
| EMG bandwidth | 70-480Hz | N/A | 10Hz-1kHz | Unknown | N/A | EMG detection | N/A | N/A | Bipolar | N/A | N/A | N/A | Bipolar | Bipolar |
| EMG signal processing (eg.<br>RMS) | AVR<br>(Average Rectified Value) | N/A | RMS<br>(Root Mean Square) | Unknown | N/A | EMG range (μV) | N/A | N/A | 1-2000μV | N/A | N/A | N/A | 1-2000μV | 1-2000μV |
| Synchronous or Alternating? | Alternating | Unknown | Alternating | N/A | Synchronous | EMG bandwidth | N/A | N/A | 70-480Hz | N/A | N/A | N/A | 70-480Hz | 70-480Hz |
| Method of Channel Isolation | Transformer, Inductive<br>couplers | Unknown | Unknown | Unknown | Transformer | EMG signal proc.<br>Synchr. or Altern.? | N/A<br>Alternating | N/A<br>Alternating | AVR<br>Alternating | N/A<br>Alternating | N/A<br>Alternating | N/A<br>Alternating | AVR<br>Alternating | AVR<br>Alternating |
| Regulated Current or<br>Regulated Voltage? | Regulated Current | Regulated Current | Regulated Current | Regulated Current | Regulated Current | Meth. Chan. Isol. | Transformer,<br>Inductive couplers | Transformer, Opt<br>isolator | Transformer,<br>Inductive couplers | Transformer, Opt<br>isolator | Transformer,<br>Inductive couplers | Transformer, Opt<br>isolator | Transformer,<br>Inductive couplers | Transformer, Opt<br>isolator |
| Software/Firmware/<br>Microprocessor Control? | Yes | Yes | Yes | Yes | Yes | RC or RV? | Regulated Current | Regulated Voltage | Regulated Current | Regulated Voltage | Regulated Current | Regulated Voltage | Regulated Current | Regulated Voltage |
| PC Software? | Yes | No | Yes | No | No | Firmware/?<br>PC Software? | Yes<br>No | Yes<br>No | Yes<br>No | Yes<br>No | Yes<br>No | Yes<br>No | Yes<br>No | Yes<br>No |
| Automatic Overload Trip? | Yes | Yes | Yes | Yes | Yes | Aut. Overload Trip | Yes | Unknown | Yes | Unknown | Yes | Unknown | Yes | Unknown |
| Automatic No-Load Trip? | Yes | Yes | Yes | Yes | Yes | Aut. No-Load Trip | Yes | Unknown | Yes | Unknown | Yes | Unknown | Yes | Unknown |
| Automatic Shut Off? | Yes (10min) | Unknown | Unknown | Unknown | Unknown | Aut. Shut Off | Yes (10min) | No | Yes (10min) | No | Yes (10min) | No | Yes (10min) | No |
| Patient Override Control? | Yes (Stop Button) | Yes | Yes | Yes | Yes | Override Control?<br>Display: On/Off? | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes |
| Indicator Display: On/Off<br>Status? | Yes | Yes | Yes | Yes | Yes | Display: Low Batt? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Indicator Display: Low Batt.? | Yes | Yes | Yes | Yes | Yes | Display: V/C Level | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Indicator Display:<br>Voltage/Current Level? | Yes | Yes | Yes | Yes | Yes | Timer Range | 15-60min | Max. 90min | 15-60min | Max. 90min | 15-60min | Max. 90min | 15-60min | Max. 45min |
| Timer Range [minutes] | 2 - 120min | 5 - 95min and cont. | 1 - 120min | Unknown | 3 - 84min | Compliance with<br>Voluntary<br>Standards? | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Unknown | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Unknown | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Unknown | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Unknown |
| Compliance with Voluntary<br>Standards? (if yes, specify) | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Unknown | Unknown | Unknown | Compliance with<br>21 CFR 898? | Yes | Unknown | Yes | Unknown | Yes | Unknown | Yes | Unknown |
| Compliance with 21 CFR 898? | Yes | Unknown | Unknown | Unknown | Unknown | Weight | 440g | 685g | 440g | 685g | 440g | 685g | 440g | 685g |
| Weight | 440g | 158g | 330g | Unknown | 420g | Dimensions<br>(WxHxD) in (mm) | 175x95x30 | 172x91x40<br>(Control unit) | 175x95x30 | 172x91x40<br>(Control unit) | 175x95x30 | 172x91x40<br>(Control unit) | 175x95x30 | 172x91x40<br>(Control unit) |
| Dimensions (WxHxD) in [mm] | 175x95x30 | 114x60x31 | 102x152x51 | Unknown | 148x80x30 | Housing Material<br>and Construction | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics |
| Housing Material and Constr. | Plastics | Plastics | Plastics | Plastics | Aluminium | Output<br>Specifications | | | | | | | | |
| Output Specifications | | | | | | Waveform | Biphasic<br>symmetrical | Biphasic<br>symmetrical | Biphasic<br>symmetrical | Biphasic<br>symmetrical | Biphasic<br>symmetrical | Biphasic<br>symmetrical | Biphasic<br>symmetrical | Biphasic<br>symmetrical |
| Waveform | Biphasic symmetrical | Biphasic asymmetrical | Biphasic asymmetrical | Biphasic symmetrical | Biphasic symmetrical, Triangular | Shape | Rectangular | Sinusoidal | Rectangular | Sinusoidal | Rectangular | Sinusoidal | Rectangular | Sinusoidal |
| Shape | Rectangular | Rectangular with discharge | Rectangular with discharge | Rectangular | Rectangular | Maximum Output<br>Voltage (500Ω) | 50V | 106V | 50V | 106V | 50V | 106V | 50V | 106V |
| Maximum Output Voltage<br>(500Ω) | 50V | 50V | 50V | Unknown | 50V | Maximum Output<br>Voltage (2kΩ) | 115V | 163V | 115V | 163V | 115V | 163V | 115V | 163V |
| Maximum Output Voltage<br>(2kΩ) | 115V | 164V | Unknown | Unknown | 200V | Maximum Output<br>Voltage (10kΩ) | N/A | Unknown | N/A | Unknown | N/A | Unknown | N/A | Unknown |
| Maximum Output Voltage<br>(10Ω) | N/A | Unknown | Unknown | Unknown | N/A | Maximum Output<br>Current (500Ω) | 100mA | 212mA | 100mA | 212mA | 100mA | 212mA | 100mA | 212mA |
| Maximum Output Current<br>(500Ω) | 100mA | 100mA | 100mA | Unknown | 100mA | Maximum Output<br>Current (2kΩ) | 58mA | 92mA | 58mA | 92mA | 58mA | 92mA | 58mA | 92mA |
| Maximum Output Current<br>(2kΩ) | 58mA | 82mA | Unknown | Unknown | 100mA | Maximum Output<br>Current (10kΩ) | N/A | Unknown | N/A | Unknown | N/A | Unknown | N/A | Unknown |
| Maximum Output Current<br>(10Ω) | N/A | Unknown | Unknown | Unknown | N/A | Pulse Width | 50-400μs | 100-350μs | 50-400μs | 100-350μs | 50-400μs | 100-350μs | 50-400μs | 100-500μs |
| Pulse Width (specify units) | 50μs - 400μs | 100μs - 400μs | 50μs - 400μs | 320μs | 15μs – 999μs | Frequency [Hz] | 1-140Hz<br>Default: 35Hz | 38Hz | 1-140Hz<br>Default: 35Hz | 38Hz | 1-140Hz<br>Default: 35Hz | 38Hz | 1-140Hz<br>Default: 35Hz | 18Hz |
| Frequency (Hz) | 1-140Hz | 2-100Hz | 2-100Hz | 3,1kHz GF, 33Hz AMF | 1-200Hz | Net Charge [μC<br>per pulse]; (500Ω) | 0μC | 0μC | 0μC | 0μC | 0μC | 0μC | 0μC | 0μC |
| For interferential modes only:<br>Beat Frequency (Hz) | N/A | N/A | N/A | N/A | N/A | Maximum Phase<br>Charge [μC]<br>(500Ω) | 40μC | 75μC | 40μC | 75μC | 40μC | 75μC | 40μC | 106μC |
| For multiphasic waveforms<br>only: Symmetrical phases? | N/A | N/A | N/A | N/A | N/A | Maximum Current<br>Density (mA/cm²)<br>(500Ω) | 12,5mA/cm² | 15,9mA/cm² | 12,5mA/cm² | 15,9mA/cm² | 12,5mA/cm² | 15,9mA/cm² | 12,5mA/cm² | 15,9mA/cm² |
| For multiphasic waveforms<br>only: Phase Duration (including<br>units); | N/A | N/A | N/A | N/A | N/A | Maximum Power<br>Density [W/cm²]<br>(500Ω) | 7,9mW/cm² | 0,39 mW/cm² | 7,9mW/cm² | 0,39 mW/cm² | 7,9mW/cm² | 0,39 mW/cm² | 7,9mW/cm² | 0,39 mW/cm² |
| Net Charge [μC per pulse];<br>(500Ω) | 0μC<br>Some positive and negative<br>impulse | 0μC<br>Output capacitor | 0μC<br>Output capacitor | 0μC<br>Some positive and negative<br>impulse | 0μC<br>Some positive and negative<br>impulse | Burst Mode:<br>Pulses per burst | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Maximum Phase Charge [μC]<br>(500Ω) | 40μC | 40μC | 60μC | Unknown | 80μC | Burst Mode:<br>Bursts per second | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Maximum Current Density<br>[mA/cm²] (500Ω) | 12.5mA/cm² | 5.3mA/cm² | 20.4mA/cm² | Unknown | 5.0mA/cm² | Burst Mode: Burst<br>duration (seconds) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Maximum Power Density<br>[W/cm²] (500Ω) | 7.9mW/cm² | 1.7mW/cm² | 6.5mW/cm² | Unknown | 39.9mW/cm² | Burst Mode: Duty<br>Cycle | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Burst Mode (i.e., pulse trains):<br>Pulses per burst | N/A | N/A | N/A | N/A | N/A | ON Time (sec.) | 1 - 20s | Unknown | 1 - 20s | Unknown | 1 - 20s | Unknown | 1 - 20s | Trigger controlled |
| Burst Mode (i.e., pulse trains):<br>Bursts per second | N/A | N/A | N/A | N/A | N/A | OFF Time (sec.) | 1 - 30s | Unknown | Trigger controlled<br>(min. 1 - 30s) | Unknown | 1 - 30s | Unknown | Trigger controlled<br>(min. 1 - 30s) | Trigger controlled |
| Burst Mode (i.e., pulse trains):<br>Burst duration (seconds) | N/A | N/A | N/A | N/A | N/A | | | | | | | | | |
| Burst Mode (i.e., pulse trains):<br>Duty Cycle [Line (b) ÷ Line (c)] | N/A | N/A | N/A | N/A | N/A | | | | | | | | | |
| ON Time [seconds] | 1 - 20s | 2 - 20s | 2 - 20s | Default 6s | Unknown | | | | | | | | | |
| OFF Time [seconds] | 1 - 50s | 2 - 20s | 2 - 50s | Default 12s | Unknown | | | | | | | | | |

Otto Bock Hoolthcore Products

HG WIEN FN 242378p UID-Nr.: ATU 57529204 ARA-Nr.: 8864 ERA-Nr.: 5041

Bonk Austria Creditorstalt Aktiengesellschett, Filiale Westball Crown BLZ 12 000, Konto. Nr. 08743146400

{3}------------------------------------------------

Otto Bock®

## QUALITY FOR LIFE

Functional Electrical Stimulation Programs:

### Otto Bock Healthcare Products GmbH

Kaiserstraße 39 · 1070 Wien · Austrio · Telefox ([phone] · e-mail: vertrieb.austria@[e-mail] · www.ottobock.ct Kundenservice: Telefon [phone] · Telefox ([phone]

HG WIEN FN 242378p · UID-Nr.: ATU 57529204 · ARA-Nr.: 8864 · ERA-Nr.: 5041

HO WEN FN 242376 - SUDN: : ATU 5752920 - ARA-N: : 884 - ERA-N: 5041
Bonk Austria Creditors (Alicel Vestbohstrode Swit Code: BKAUATWW BLZ 12 000, Konto-Nr. 08743146400

{4}------------------------------------------------

Otto Bock®

Incontinence Programs:

| Characteristics/<br>Specifications | New Device | Predicate<br>Device | New Device | Predicate<br>Device | New Device | Predicate<br>Device | New Device | Predicate<br>Device | |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|-----------------------------------|-----------------------------------|-------------|
| Basic Unit<br>Characteristics | | | | | | | | | |
| Program | U1 | P2, P3 | U2 | P1 | U3 | P4 | U4 | EMG Script | |
| 510(k) Number | K080950 | K032988 | K080950 | K032988 | K080950 | K032988 | K080950 | K053434 | |
| Manufacturer | Otto Bock | Donnermeter A/S | Otto Bock | Donnermeter A/S | Otto Bock | Donnermeter A/S | Otto Bock | Thought<br>Technology Ltd. | |
| Device Name | STIWELL med4 | Elpha 4 Conti | STIWELL med4 | Elpha 4 Conti | STIWELL med4 | Elpha 4 Conti | STIWELL med4 | Myotroc Infinity | |
| Power Source(s) | Battery Pack Li-<br>Ion 11,1V | Battery NMH or<br>Alkaline 9V | Battery Pack Li-<br>Ion 11,1V | Battery NMH or<br>Alkaline 9V | Battery Pack Li-<br>Ion 11,1V | Battery NMH or<br>Alkaline 9V | Battery Pack Li-<br>Ion 11.1V | Battery Pack<br>NIMH | |
| Method of Line<br>Current Isolation | Medical Class II<br>Power Adapter | N/A | Medical Class II<br>Power Adapter | N/A | Medical Class II<br>Power Adapter | N/A | Medical Class II<br>Power Adapter | Medical Class II<br>Power Adapter | |
| Leakage Current<br>(normal condition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | |
| Leakage Current<br>(single fault cond.) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | |
| No. Output Mod. | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | |
| No. Output Chan | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| No. of EMG Chan.<br>EMG sensitivity | N/A | N/A | N/A | N/A | N/A | N/A | 1μV | <0,1μV | |
| EMG Sampl. Rate | N/A | N/A | N/A | N/A | N/A | N/A | 3kHz | 2,048kHz | |
| EMG detection | N/A | N/A | N/A | N/A | N/A | N/A | Bipolar | Bipolar | |
| EMG range (μV) | N/A | N/A | N/A | N/A | N/A | N/A | 1-2000μV | 0-2000μV | |
| EMG bandwidth | N/A | N/A | N/A | N/A | N/A | N/A | 70-480Hz | 10Hz-1kHz | |
| EMG signal proc. | N/A | N/A | N/A | N/A | N/A | N/A | AVR | RMS | |
| Synchr. or Altern.? | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Math. Chan. Isol.<br>RC or RV7 | Regulated Current | Regulated Current | Regulated Current | Regulated Current | Regulated Current | Regulated Current | N/A | N/A | |
| Firmware/? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Aut. Overload Trip | Yes | Yes | Yes | Yes | Yes | Yes | N/A | N/A | |
| Aut. No-Load Trip | Yes | Yes | Yes | Yes | Yes | Yes | N/A | N/A | |
| Aut. Shut Off | Yes (10min) | Yes | Yes (10min) | Yes | Yes (10min) | Yes | Yes (10min) | Unknown | |
| Override Control? | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes | |
| Display: On/Off? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Display: Low Batt? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Timer Range | 5 - 25min | 5 - 95min | 5 - 25min | 5 - 95min | 5 - 25min | 5 - 95min | 2-4min | 1-120min | |
| Compliance with<br>Voluntary<br>Standards? | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | IEC 60601-1<br>IEC 60601-1-2 | Unknown | |
| Compliance with<br>21 CFR 898? | Yes | Unknown | Yes | Unknown | Yes | Unknown | Yes | Unknown | |
| Weight | 440g | 158g | 440g | 158g | 440g | 158g | 440g | 330g | |
| Dimensions<br>(WxHxD) in (mm) | 175x95x30 | 114x60x31 | 175x95x30 | 114x60x31 | 175x95x30 | 114x60x31 | 175x95x30 | 102x152x51 | |
| Housing Material<br>and Construction | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics | |
| Output<br>Specifications | | | | | | | | | |
| Waveform | Biphasic<br>symmetrical | Pulsed biphasic<br>asymmetrical | Biphasic<br>symmetrical | Pulsed biphasic<br>asymmetrical | Biphasic<br>symmetrical | Pulsed biphasic<br>asymmetrical | N/A | N/A | |
| Shape | Rectangular | Rectangular with<br>discharge | Rectangular | Rectangular with<br>discharge | Rectangular | Rectangular with<br>discharge | N/A | N/A | |
| Maximum Output<br>Voltage (500Ω) | 50V | 50V | 50V | 50V | 50V | 50V | N/A | N/A | |
| Maximum Output<br>Voltage (2kΩ) | 115V | 150V | 115V | 150V | 115V | 150V | N/A | N/A | |
| Maximum Output<br>Voltage (10kΩ) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Maximum Output<br>Current (500Ω) | 100mA | 100mA | 100mA | 100mA | 100mA…