Search Results
Found 1 results
510(k) Data Aggregation
K Number
K110390Device Name
ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
Manufacturer
Date Cleared
2011-07-29
(168 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
HANDELSHAUS DITTMAN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ETG 255 Combo Stimulator,
For TENS mode
Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain.
For EMS mode
1. Relaxation of muscle spasm.
2. Increase of local blood flow circulation
3. Prevention or retardation of disuse atrophy
4. Muscle re-education
5. Maintaining or increasing range of motion.
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
TEN 260 Stimulator
Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain.
Device Description
ETG 255 Combo Stimulator, TEN 260 Combo Stimulator are non-invasive devices. The devices contain the following main parts: TENS stimulation unit, Support Belt, electrode, and snap cable. The electrode is permanently sewn up in the support belt. Each belt is flexible, and is available in range of sizes to ensure good patient contact. A male snap connector is placed within the electrode and is connected via the female snap connector to a short lead wire. The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator. The device can be worn on the low back part of user so as to place the electrode on the treatment location of low back.
Ask a Question
Ask a specific question about this device
Page 1 of 1