(364 days)
Not Found
No
The summary describes a neuromuscular electronic stimulator with biofeedback capabilities. It mentions adjustable programs and data retrieval, but there is no mention of AI, ML, or any technology that would adapt or learn based on data. The device appears to be based on pre-programmed stimulation and biofeedback protocols.
Yes
The device is indicated for various medical conditions and treatments, including muscle spasm relaxation, pain relief, and urinary incontinence treatment, all of which fall under therapeutic applications.
No
The device description primarily highlights its use as a stimulator for therapeutic applications (neuromuscular stimulation, TENS, biofeedback, functional stimulation, continence device). While it has "two EMG measurement channels" and can "assess EMG activity," which involves measurement, its stated "intended use" and "indications for use" are all related to treatment, therapy, or management of conditions, not diagnosis. It's used to monitor progress of therapy, not to identify a disease or condition.
No
The device description explicitly states it is a "neuromuscular electronic stimulator" with "four stimulation channels and two EMG measurement channels," indicating it is a hardware device that delivers electrical stimulation and measures EMG signals.
Based on the provided information, the STIWELL med4 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- STIWELL med4 Function: The STIWELL med4 is a neuromuscular electronic stimulator, transcutaneous electrical nerve stimulator, biofeedback device, external functional neuromuscular stimulator, and nonimplanted electrical continence device. Its functions involve applying electrical stimulation to the body, measuring electrical activity (EMG), and providing biofeedback. These actions are performed on the body (in vivo or externally), not on specimens taken from the body.
- Intended Use: The intended uses listed are all related to treating medical conditions through electrical stimulation, biofeedback, and muscle re-education. None of the indications involve analyzing biological samples.
- Device Description: The description focuses on the device's hardware (stimulation and EMG channels) and its use in a clinical and home setting, not on laboratory analysis of samples.
Therefore, the STIWELL med4 falls under the category of a therapeutic or diagnostic device used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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 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 urinary 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
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ, HCC, GZI, KPI
Device Description
The STIWELL med4 is powered by rechargeable batteries. It has four stimulation channels and two EMG measurement channels.
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
Not Found
Intended User / Care Setting
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.
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)
Functional and safety tests were carried out according to the following standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-10, IEC 721-3-2, ISO 2248, ISO 2876, IEC 60512-8, IEC 60512-9, IEC 68-1 +Corr.+A1, IEC 68-2-1 +A1+A2, IEC 68-2-2 +IEC68-2-2A+A2, IEC 68-2-30, IEC 68-2-33, IEC 68-2-36, IEC 68-2-78, 21 CFR 898.
The conclusion is that "The STIWELL med4 stimulation device is safe and effective for its intended use. The STIWELL med4 is substantially equivalent to the predicate devices."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K032954, K053434, K040849, K940301, K032988, K031900
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: +43 1 523 37 86 692 Fax Number: +43 1 523 22 64 Juergen Weiss Contact: Regulatory Affairs Manager
B Contact:
Otto Bock Healthcare Product GmbH Kaiserstrasse 39 1070 Vienna Austria
+43 1 523 37 86 692 Telephone: Fax Number: +43 1 523 22 64 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, | ||
| Transcutaneous, For Pain Relief | GZJ | Neurology | ||
| II | 882.5050 | Device, Biofeedback | HCC | Neurology |
| II | 882.5810 | Stimulator, Neuromuscular, | ||
| External Functional | GZI | Neurology | ||
| II | 876.5320 | Stimulator, Electrical, Non- | ||
| Implantable, For Incontinence | KPI | Gastroenterology/ | ||
| Urology |
Otto Bock Healthcare Products GmbH
Koiserstraße 39 - 1070 Wien - Austria Telefox (+43-1) 523 22 64 - e-moil: vertreb.austria@ottobock.com · www.ottobock.at Kundenservice: Telefon (+43-1) 526 95 48 · Teletax (+43-1) 526 79 85 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)
No. | Predicate Device | Manufacturer | Regulation
Number | Product
Code(s) | Clearance
Date |
|---------------|--------------------------------------------------------|----------------------------------------------------------------|----------------------|--------------------|-------------------|
| K032954 | Elpha Models II
500, II 1000, II
2000, II 3000 A | Danmeter A/S | 890.5850 | IPF, GZJ | 08/09/2004 |
| K053434 | Myotrac Infinity
Electrical Stimulator | Thought
Technology Ltd. | 876.5320 | KPI,
HCC, IPF | 03/15/2006 |
| K040849 | Mentamove | Cole &
Associates | 890.5850 | IPF, HCC | 10/01/2004 |
| K940301 | Compex 2 | Biodex Medical
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-
Neuromuscular
Electrical
Stimulation
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 (+43 1) 523 22 64 • e-mail: vertrieb.costria@ottobock.com • www.attobock.cl Kundenservice: Telefon (+43-1) 526 95 48 · Telefax (+43-1) 526 79 85 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,
Basic Unit Characteristics | New Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Characteristics/
Specifications
Basic Unit
Chrocteristics | New Device | Predicate
Device | New Device | Predicate
Device | New Device | Predicate
Device | New Device | Predicate
Device |
|-------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------|----------------------------------------------|----------------------------------------------|----------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------|------------------------------------|---------------------------------------------------|------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------|
| 510(k) Number | K080950 | K032954 | K053434 | K040849 | K940301 | Program | FES 1
Grasp/Release | Exercise Open | FES 2
Grasp/Release
(EMG) | Exercise Open | FES 3
Open/Close | Exercise | FES 4
Open/Close
(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
Isolation | Medical Class II Power
Adapter - Mascot
(12,6VDC-15,1W) | N/A | Medical Class II Power
Adapter (6VDC-15W) | Battery Charger (6VDC-2,1W) | Battery Charger (11VDC-7,2W) | Power Source(s) | Battery Pack Li-
Ion 11,1V | Battery Pack Ni
Cd 9,6V | Battery Pack Li-
Ion 11,1V | Battery Pack Ni
Cd 9,6V | Battery Pack Li-
Ion 11,1V | Battery Pack Ni
Cd 9,6V | Battery Pack Li-
Ion 11,1V | Battery Pack Ni
Cd 9,6V |
| Patient Leakage Current
(normal condition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | Method of Line
Current Isolation | Medical Class II
Power Adapter | N/A | Medical Class II
Power Adapter | N/A | Medical Class II
Power Adapter | N/A | Medical Class II
Power Adapter | N/A |
| Patient Leakage Current
(single fault condition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | Leakage Current
(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
(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)
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 |