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510(k) Data Aggregation
K Number
K060669Device Name
MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300
Manufacturer
HEALTHONICS, INC.
Date Cleared
2006-10-13
(213 days)
Product Code
GZJ, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
HEALTHONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Prescription Use Model SE-100:
- Relief of chronic intractable pain. .
- Adjunctive treatment of post-surgical or post-traumatic acute pain. .
For Prescription Use Models ST-150, ST-200 and ST-300:
- Relief of chronic intractable pain. .
- Adjunctive treatment of post-surgical or post-traumatic acute pain. .
- Adjunctive therapy in reducing the level of pain associated with osteoarthritis of the ● knee.
- Adjunctive therapy in reducing the level of pain from rheumatoid arthritis of the hand. .
Device Description
The MedRelief" ST Series™, consisting of models ST-100, ST-150, ST-200 and ST-300, is designed to provide subthreshold electrical stimulation for acute and chronic pain, including pain, including pain from osteoarthritis and rheumatoid arthritis, in a single compact, lightweight and user-friendly package. "Subthreshold" stimulation does not normally cause sensation or muscle contraction, but acts at a cellular level to relieve pain.
Each device in the ST Series is comprised of the following main components.
- A power section consisting of battery, switch, test and conditioning components; .
- A dosing timer, initialized at power-on and providing a choice of treatment times; .
- A control oscillator, providing pulse-burst timing; .
- A pulse oscillator, providing timing for individual pulses; and .
- An output section, providing filtering, DC blocking and intensity control.
While some components are digital, all functions are hard-wired and there is no microprocessor or software used. Output is by means of lead wires and skin-contact electrodes already commercially available and legally sold by others.
The member devices in the ST Series™ differ only in the complexity of their controls and number of physician or user options which each model offers.
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K Number
K030998Device Name
MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300
Manufacturer
HEALTHONICS, INC.
Date Cleared
2003-10-10
(193 days)
Product Code
IPF, GZJ, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
HEALTHONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedRelief SE-50 and SE-100. and the MedRelief SE-200 and SE-300 in subthreshold and interferential modes, are intended for the following indications:
- Relief of chronic intractable pain. .
- Adjunctive treatment of post-surgical or post-traumatic acute pain. .
The MedRelief SE-200 and SE-300 in muscle stimulation mode are intended for the following indications:
- Relaxation of muscle spasms. ●
- Prevention or retardation of disuse atrophy. .
- Muscle re-education. .
- . Increasing local blood circulation.
- Maintaining or increasing range of motion .
- . Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (SE-300 only).
For the SE-200 and SE-300 in muscle stimulation mode, the lowest three intensity settings may not provide effective muscle contractions to achieve the indications for use, especially when applied to large muscles or muscle groups. These settings are provided so that the intensity may be ramped up slowly for improved user comfort.
Device Description
The MedRelief SE Series™ provides a selection of both high-level and subthreshold electrotherapeutic modes in a compact, lightweight and userfriendly package. "Subthreshold" as used here means electrical stimulation not strong enough to cause nerve depolarization or muscle contraction, but still active at a cellular level, as in microcurrent TENS. Healthonics' proprietary version of subthreshold stimulation has been named Structured Energy™
Devices in the MedRelief SE Series™ provide combinations of these stimulation modes as follows:
| Model<br>number | Includes: muscle<br>stimulation | interferential<br>stimulation | Structured<br>EnergyTM | Controls |
|-----------------|---------------------------------|-------------------------------|------------------------|----------|
| SE-300 | X | X | X | Rotary |
| SE-200 | X* | X* | X | Rotary |
| SE-100 | -- | -- | X | Rotary |
| SE-50 | -- | -- | X | Recessed |
* - Output provided over reduced intensity range.
Models SE-200™ and SE-300™ provide all three stimulation modes, while Models SE-50™ and SE-100™ are miniaturized, single-mode Structured Eneray™-only versions. All devices are completely powered by 9-volt batteries, without provisions for line power or AC adapters. All devices are single-channel only.
All SE Series ™ devices produce trains of brief electrical pulses which are applied to the body through self-adhesive electrodes placed on the skin. Pulses recur at a nominal 4150 Hz and may be either 30 microseconds or 120 microseconds long. These pulses form a carrier wave which may then be modulated by one of three different envelopes, yielding respectively Structured Energy™, muscle stimulation, or premodulated interferential stimulation. Envelope frequencies range from 0.25 Hz to 130 Hz, depending on the mode being used.
All functions for a particular mode are preset, and accessed through a single rotary switch which also turns the device on and off. In the SE-200™ and SE-300™, a second rotary switch provides intensity control. In the SE-100™, all control functions are integrated into a single rotary switch, while in the SE-50™ this switch is replaced by two recessed, miniature slide switches.
While the MedRelief SE Series™ incorporates some ancillary digital components such as frequency dividers, its primary functioning is analog, with all digital functions hard-wired. Since there is no microprocessor, no software is needed.
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K Number
K003507Device Name
MEDRELIEF
Manufacturer
HEALTHONICS, INC.
Date Cleared
2001-02-21
(100 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
HEALTHONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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