(204 days)
No
The summary describes a standard electrical muscle stimulation (EMS) device with pre-set programs and does not mention any adaptive, learning, or intelligent features. The testing focuses on electrical safety and performance specifications, not on AI/ML model validation.
No
The device explicitly states it is "not intended to be used in conjunction with therapy or treatment of medical conditions of any kind" and must be used for "healthy muscles and clients, not for rehabilitation purposes."
No
Explanation: The device description and intended use clearly state that WIEMSPRO is for stimulating healthy muscles to improve performance and is "not intended to be used in conjunction with therapy or treatment of medical conditions of any kind" and "not for rehabilitation purposes." Diagnostic devices are used to identify or analyze medical conditions.
No
The device description explicitly states it is an "electro-medical device" and a "machine with electronic muscle stimulation based on EMS technology," indicating it includes hardware components for electrical stimulation. The performance studies also detail testing related to electrical safety and electromagnetic compatibility, which are relevant to hardware.
Based on the provided text, the WIEMSPRO device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- WIEMSPRO Function: The WIEMSPRO is described as an electro-medical device that uses electrical muscle stimulation (EMS) technology to stimulate healthy muscles externally. It does not involve testing samples from the body.
- Intended Use: The intended use is to "stimulate healthy muscles in order to improve or facilitate muscle performance." This is a physical intervention, not a diagnostic test.
- Device Description: The description reinforces that it's an "electro-medical device intended for stimulating healthy muscles."
- Lack of IVD Characteristics: The text does not mention any aspects related to sample collection, analysis of biological samples, or diagnostic purposes.
Therefore, the WIEMSPRO falls under the category of an electro-medical device for muscle stimulation, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
WIEMSPRO is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSPRO is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
WIEMSPRO electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
Product codes
NGX
Device Description
The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances.
WIEMSero is a device with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes. The device must be used over user's cotton undergarments and is therefore not patient-contacting
WIEMSPRO system cannot be used while the user is in motion or lifting weights.
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
Not Found
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
The proposed device has been subject to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a wireless electro muscle stimulation device for fitness.
Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:
- Electrical safety (including particular requirements for the basic safety and essential performance of nerve and muscle stimulator and for medical electrical equipment)
- Electromagnetic compatibility
- FCC Radio Frequency Testing The WiEMSpro device was tested to FCC requirements and found to comply with the requirements of 47 CFR Part 15 §15.107 and §15.109.
No clinical studies are submitted.
Key Metrics
Not Found
Predicate Device(s)
E-Fit EF-1280 (K133225), Compex Wireless USA (K170903)
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).
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February 12, 2019
Medical Cables, S.L. José Fuertes Peña Manager Duque de la Victoria 6, 1º Malaga, Spain 29015
Re: K181955
Trade/Device Name: WIEMSPRO Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 18, 2018 Received: January 16, 2019
Dear José Fuertes Peña:
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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181955
Device Name WIEMSPRO
Indications for Use (Describe)
WIEMSPRO is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSPRO is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
WIEMSPRO electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
| 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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3
510(k) Premarket medicalcables WIEMSpro Notification DATE OF SUBMISSION: 2018-03-02 SUBMITTER NAME: Medical Cables, S.L. SUBMITTER ADDRESS: Duque de la Victoria 6, 1º 29015, Malaga SPAIN CONTACT: José Fuertes Peña TELEPHONE: +34 95 221 89 91 E-mail: ifuertes@medicalcables.eu DEVICE TRADE NAME: WIEMSpro COMMON NAME: Powered muscle stimulator. Stimulator, Muscle, Powered, For Muscle Conditioning CLASSIFICATION NAME: (21 CFR 890.5850) E-Fit EF-1280 (K133225) PREDICATE DEVICE(S): Compex Wireless USA (K170903)
DEVICE DESCRIPTION:
The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances.
WIEMSero is a device with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes. The device must be used over user's cotton undergarments and is therefore not patient-contacting
WIEMSPRO system cannot be used while the user is in motion or lifting weights.
SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
In the establishment of substantial equivalence, the WIEMSPRO device is compared with the following previously cleared devices:
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510(k) Premarket Notification
Comparison of the proposed devices with the predicate devices is summarized in the following table:
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||||
|---|---|---|---|---|
| Characteristic / | ||||
| Feature | PROPOSED DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | Comparison |
| WIEMSPRO | E-Fit EF-1280 | Compex Wireless USA | ||
| GENERAL COMPARISON | ||||
| Classification | ||||
| name | Powered muscle stimulator | Powered muscle | ||
| stimulator | Powered muscle stimulator | Same | ||
| Product code | NGX | NGX | NGX | Same |
| Regulation | ||||
| number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Panel | Physical Medicine | Physical Medicine | Physical Medicine | Same |
| Class | Class II | Class II | Class II | Same |
| 510(K) Number | -- | K133225 | K170903 | N/A |
| INTENDED USE | ||||
| Indication for | ||||
| use | WIEMSPRO is intended to | |||
| stimulate healthy muscles in | ||||
| order to improve or facilitate | ||||
| muscle performance. The | ||||
| WIEMSPRO is not intended to | ||||
| be used in conjunction with | ||||
| therapy or treatment of medical | ||||
| diseases or medical conditions | ||||
| of any kind. None of | ||||
| WIEMSPRO training programs is | ||||
| designed for injured or ailing | ||||
| muscles and its use on such | ||||
| muscles is contraindicated. |
WIEMSPRO is a machine with
electronic muscle stimulation
based on EMS technology.
Regarding its use, the device is
specifically designed as an
addition to other sports and for
training muscles. It must be
used for only healthy muscles
and clients, not for
rehabilitation purposes.
WIEMSPRO electrical impulses
allow the triggering of action
potentials on motoneurones of
motor nerves (excitations).
These excitations of
motoneurones are transmitted
to the muscle fibers via the
motor endplate where they
generate mechanical muscle
fiber responses that
correspond to muscle work.
Depending on the parameters
of the electrical impulses
(pulse frequency, duration of
contraction, duration of rest,
total session duration),
different types of muscle work | E-fit EF-1280 is a machine
with electronic muscle
stimulation based on EMS
technology. Regarding its
use, the device is
specifically designed as an
addition to other sports
and for training muscles. It
must be used for only
healthy muscles and
clients, not for
rehabilitation purposes.
The E-Fit EF-1280
intended to stimulate
healthy muscles in order to
improve or facilitate
muscle performance. The
E-Fit EF-1280 is not
intended to be used in
conjunction with therapy or
treatment of medical
diseases or medical
conditions of any kind.
None of the E-Fit EF-1280
training programs is
designed for injured or
ailing muscles and its use
on such muscles is
contraindicated.
The E-Fit EF-1280
electrical impulses allow
the triggering of action
potentials on
motoneurones of motor
nerves (excitations).
These excitations of
motoneurones are
transmitted to the muscle
fibers via the motor | The Compex Wireless USA is an
Over-The-Counter device
intended to stimulate healthy
muscles in order to improve or
facilitate muscle performance. It
is to be used by adults only.
The Compex Wireless USA is not
intended for adjunctive therapy in
the treatment of medical
diseases and conditions of any
kind. None of the Compex
Wireless USA stimulation
programs are designed for
injured or disease afflicted
muscles. Its use on such
muscles is contraindicated. The
work imposed on the muscles by
the Compex Wireless USA
programs is definitely not suitable
for rehabilitation and
physiotherapy. The Compex
Wireless USA electrical impulses
allow the triggering of action
potentials on motoneurones of
motor nerves (excitations). These
excitations of motoneurones are
transmitted to the muscle fibers
via the motor endplate where
they generate mechanical
muscle fiber responses that
correspond to muscle work.
Depending on the parameters of
the electrical impulses (pulse
frequency, duration of
contraction, duration of rest, total
session duration), different types
of muscle work can be imposed
on the stimulated muscles. The
Compex Wireless USA may
therefore be considered a
technique of muscle training. | Same
WIEMSPRO
does not
include
TENS |
| | | | | |
| Intended use | can be imposed on the stimulated muscles. | endplate where they
generate mechanical
muscle fiber responses
that correspond to muscle
work. Depending on the
parameters of the
electrical impulses (pulse
frequency, duration of
contraction, duration of
rest, total session
duration), different types of
muscle work can be
imposed on the stimulated
muscles.
The various types of
muscle work that the E-Fit
EF-1280 can impose on
the stimulated muscles are
able to improve or facilitate
muscle performance. The
E-Fit EF-1280 may
therefore be considered a
technique of muscle
training.
Must be used for only
healthy muscles and
client. It is not intended to
be used in conjunction
with therapy or treatment
of medical diseases or | The Compex Wireless USA
TENS is used for:
· temporary relief of pain
associated with sore and aching
muscles due to strain from
exercise or normal household
and work activities.
· the symptomatic relief and
management of chronic,
intractable pain and relief of pain
associated with arthritis.
Must be used for only healthy
muscles and client. It is not
intended to be used in
conjunction with therapy or
treatment of medical diseases or
medical conditions of any kind. | Similar.
Difference
is the
software
application
which
controls the
device |
| | Must be used for only healthy
muscles and client. It is not
intended to be used in
conjunction with therapy or
treatment of medical diseases
or medical conditions of any
kind.
It is designed to be used
together with a WIEMSPRO
Mobile Application. | medical conditions of any
kind. | | which
controls the
device |
| | Mobile Application. | TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE | | |
| Powered Muscle | | | | |
| Stimulator | YES | YES | YES | Same |
| Power Source | Battery: 3.7 V – 2,4AH (LiPo) | 12V (3,4Ah) lead Acid | Remote: : Lithium
Polymer (LiPo)
rechargeable 3.7[V] / ≥
1500[mAh
Stimulation Modules:
Lithium Polymer (LiPo)
rechargeable 3.7[V] / ≥
450[mAh] | Similar |
| Method of line
current isolation | N/A (battery operated device) | N/A (battery operated
device) | N/A (battery operated device) | Same |
| Patient leakage | | | | Same |
| current
-Normal
condition | N/A (battery operated device)
N/A (battery operated device) | N/A (battery operated
device)
N/A (battery operated
device) | N/A (battery operated device)
N/A (battery operated device) | |
| condition
-Single fault | | N/A (battery operated
device) | | |
| condition | | | | |
| Battery operated | YES | YES | YES | Same |
| Number of
output modes | One output mode, but with
varying stimulation frequency | One output mode, but with
varying stimulation | Two (NMES/TENS) | Similar as
Efit |
| | and duty cycle ranges. | frequency and duty cycle
ranges | | Different
than
Compex
WIEMSPRO
does not
include
TENS |
| Regulated
current or
regulated
voltage? | YES, regulated current | YES, regulated current | YES, regulated current | Same |
| Software/Firmwa
re/Microprocess
or Control? | YES | YES | YES | Similar as
Efit |
| Automatic
Overload Trip? | YES | YES | YES | Similar as
Compex
Similar as
Efit |
| Automatic No-
Load Trip? | YES | YES | YES | Similar as
Compex
Similar as
Efit |
| Automatic Shut
Off? | On/Off switch | On/Off switch | On/Off switch | Same as
Efit
Same as
Compex |
| Patient Override
Control? | Yes, push on On/Off button
directly pause the program | Yes, push on On/Off
button directly pause the
program | Yes, push on On/Off button
directly pause the program | Same as
Efit
Same as
Compex |
| Indicator display | Yes | Yes | Yes | Same as
Efit
Same as
Compex |
| Device weight | 300 g | N/A | Remote: 110 [g]
Stimulation
Module:2x60 [g]
Docking Station 800
[g] | Similar as
Compex |
| Dimensions (in.)
[W x H x D] | [6,66 x 3,27 x 1,18] in | Not available | Not available | Similar as
Compex
No exact
information |
| | | | | |
| Waveform (e.g.,
pulsed
monophasic,
biphasic)
(program per
program) | Symmetrical biphasic (all
programs) | Symmetric Biphasic (all
programs) | -Endurance:
Symmetrical Biphasic
-Resistance:
Symmetrical Biphasic
-Strength :
Symmetrical Biphasic
-Explosive Strength:
Symmetrical Biphasic
-Potentiation:
Symmetrical Biphasic
-Training Recovery (same
as Active Recovery):
Symmetrical Biphasic
-Competition
Recovery (same as
Recovery Plus):
Symmetrical Biphasic
-Pre-Warmup Program:
Symmetrical Biphasic
-Muscle Relaxation (same
as Massage):
Symmetrical Biphasic
-Pain relief TENS (same
as FM): Balanced,
asymmetrical Biphasic | from
predicate
devices but
not
relevant for
SE
determinati
on
Similar as
Efit
Similar as
Compex
No TENS
included in
the
WIEMSPRO
device |
| Number of
programs | 20 | 5+5 | 22 | Different
than Efit |
| Current / Voltage | 125mA/62.5V | 72mA/36V | 116mA/60V | Similar as
Compex
Different
than Efit |
| Plastic Housing
Materials | PLASTIC | STAINLESS STEEL | PLASTIC | Similar as
Compex
The
housing is
not in direct
contact
with the
client as
used over
sportswear |
| Maximum output
voltage | 170V | 66V-100V | 165V | Similar |
| Maximum output
current | 125mA | 72mA | 116mA | Similar |
| density | | | | |
| Maximum
current density | 1,92mA/cm2
Smallest electrode size: 65 cm2 | 0,85mA/cm² | 3,84mA/cm²
Smallest electrode size: 25 cm 2 | Similar |
| Number of
Output channels | 1 CHANNEL | 1 CHANNEL | 4 CHANNELS | Same as
Efit |
| Independent
channels with
possibility to
regulate the
current
individually | 10 CHANNELS | 12 CHANNELS | 4 CHANNELS | Similar as
Efit
Different
than
Compex
WIEMSPRO
only 1
channel |
| Pulse duration
(width) | 100-400usec | 100-500usec | 200 or 400usec | Similar |
| Frequency | 1-100 HZ | 5-120 HZ | 1-120 HZ | Similar
Same as
Efit |
| Reusable pads | YES | YES | NO | Different
than
Compex |
| Compliance with
voluntary
standards / LAB
tests performed | IEC 60601-1-2:2007
IEC 60601-1-6:2010
IEC 60601-2-10:2012
FCC 47 CFR Part 15
IEC 62304:2006
ISO 14971:2007
ANSI/AAMI ES60601-1:
2005 / A2:2010 | IEC 60601-1-2:2007
IEC 60601-1-11:2010
IEC 60601-2-10:2012
ISO 14971:2007 | IEC 60601-1-2:2007
IEC 60601-1-6:2013
IEC 60601-1-11:2010
IEC 60601-2-10:2012
IEC 62304:2006
ISO 14971:2007 | Similar as
Efit and
Compex
The
collateral
standard
IEC 60601-
1-11 is not
applied in
WIEMSPRO
device |
5
medicalcables
510(k) Premarket Notification
WIEMSpro
6
medicalcables
510(k) Premarket Notification
7
medicalcables
510(k) Premarket Notification
WIEMSpro
8
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510(k) Premarket Notification
Maximum output current value is higher in the WIEMSPRO device: 125 mA compared to 72 mA (E-fit) and 116 mA (Compex Wireless USA), however maximum output current density for the WIEMSpro device is of 1,92 mA/cm² much lower than that of Compex Wireless USA (3,84mA/cm²).
Also, upon analysis of the comparison of the different characteristics presented in the table above, none of the differences spotted impact the equivalence of the subject device when compared to the predicate devices.
9
INTENDED USE:
As established in the Indications for Use Statement:
WIEMSPRO intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSpro is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
WIEMSPRO electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The proposed device has been subject to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a wireless electro muscle stimulation device for fitness.
Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:
- Electrical safety (including particular requirements for the basic safety and essential performance of nerve and muscle stimulator and for medical electrical equipment)
- Electromagnetic compatibility -
- FCC Radio Frequency Testing The WiEMSpro device was tested to FCC requirements and found to comply with the requirements of 47 CFR Part 15 §15.107 and §15.109.
The new device is designed and manufactured in accordance with the following standards:
- IEC 60601-1-2:2007 ●
- IEC 60601-2-10:2012 ●
- IEC 60601-1-6 Edition 3.1 2013-10 ●
10
- ISO 14971 Second Edition 2007-03-01 ●
- EN ISO 13485:2003 /AC2009 ●
- IEC 62304:2006 ●
- ANSI/AAMI ES60601-1: 2005 / A2:2010 ●
SUMMARY DISCUSSION OF CLINICAL DATA:
Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted.
CONCLUSIONS:
We believe the intended use, the indications for use and principle of operation of WIEMSpRo are the same as the intended use, indications for use and performance of the predicate devices. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).
-
- General information of both devices is the same
-
- Intended use and indications/principle of operations of both devices are the same.
-
- There are minimum differences in the technological characteristic/performance data of the proposed device and those of the predicate devices, nevertheless, all of them comply with IEC 60601-1-2, IEC 60601-2-10. Thus the SE is not affected.
Based on the information provided in this premarket notification. Medical Cables, S.L. concludes that WIEMSER is substantially equivalent to the predicate devices with regard to safety and effectiveness.