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510(k) Data Aggregation
K Number
K181645Device Name
StimaWELL 120MTRS
Manufacturer
Date Cleared
2020-08-13
(783 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Pierenkemper GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TENS mode:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-tramautic acute pain and post surgical pain
Russian mode:
- Temporary relaxation of muscle spasms in back area
- Prevention or retardation of disuse atrophy of the lumbar paraspinal muscles
Device Description
The StimaWELL 120MTRS has been designed for the use of medium frequency electro-therapy for muscle stimulation and pain relief therapy as well as for the warming and wellness application in the back region.
The device consists of a 12 channel (electrodes) Stimulation Mat, a Controller and a Remote Control Unit. Various accessories (see 11.3.2 below) support the StimaWELL. The warming is provided through controlled resistive heating of the stimulation mat.
Interaction with the device is via a touchscreen on the controller. Selection and set-up of various treatment sequences is via the controller touchscreen or can be recalled from chip cards. The patient can interact with the device by using the remote control unit. With that he can pause the treatment at any time and also adjust the overall intensity.
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