(213 days)
No
The device description explicitly states that "all functions are hard-wired and there is no microprocessor or software used." This indicates the absence of AI/ML technology.
Yes
The device is intended for the relief of various types of pain (chronic, acute, osteoarthritis, rheumatoid arthritis), which directly addresses a health condition or symptom to restore physiological function or health, thus qualifying it as a therapeutic device.
No
This device is designed to provide "subthreshold electrical stimulation" to relieve pain, not to diagnose a condition. Its stated uses are for "relief of chronic intractable pain" and "adjunctive treatment," which are therapeutic applications.
No
The device description explicitly states that "While some components are digital, all functions are hard-wired and there is no microprocessor or software used." This indicates it is a hardware-based device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the relief of pain (chronic intractable, post-surgical/traumatic acute, osteoarthritis, rheumatoid arthritis). This is a therapeutic use, not a diagnostic one.
- Device Description: The device provides electrical stimulation through skin-contact electrodes. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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. .
Product codes
84GZJ, NYN
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Applicant: Healthonics, Inc. MedRelief®® ST Series Microcurrent TENS Traditional 510(k) Premarket Notification
Page 1:4
OCT 1 3 2006 Biophysics Health Co
510(k) Summary:
| 510(k) Owner: | Healthonics, Inc.
903 Main Street South
New Ellenton, SC 29803 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James W. Kronberg
Chief Engineer
Phone 803-652-2354
Fax 775-251-0023 |
| Date Prepared: | March 10, 2006 - Revised September 13, 2006 |
| Device Name: | MedRelief ST ("Sub-Threshold") Series, consisting
of models ST-100, ST-150, ST-200 and ST-300. |
| Common or Usual Name: | TENS device. |
| Classification Name: | Transcutaneous Electrical Nerve Stimulator for Pain
Relief. 21 CFR 882.5890, Class II, Product Code
84GZJ (prescription) or Stimulator, Electrical,
Transcutaneous, for Arthritis. 21 CFR 882.5890,
Class II, Product Code NYN (prescription). |
| Predicate Devices: | Healthonics MedRelief® SE-50 for acute and chronic
pain indications (K030998).
Bionicare Model BIO-1000 for osteoarthritis
(K030332) and rheumatoid arthritis (K983228)
indications. |
Description of the Device:
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.
1
page 2:4
Indications and Intended Use:
- . Relief of chronic intractable pain. (All modelse) ;
- . Adjunctive treatment of post-surgical or post-traumatic acute pain. {{{#=====================================================================================================
- Adjunctive therapy in reducing the level of pain and symptoms associated with . osteoarthritis of the knee. (ST-150, ST-200 and ST-300 and ST-300 and ST-300 coment
- . Adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand. (ST-150, ST-200 and ST-300 and ST-300 ember
The indications are the same as for the predicate devices listed. All units are for prescription use only. The ST-100 is a simplified unit meant for home use, with one output channel and a minimal set of signal options, closely similar to the SE-50 predicate device. Other devices in the ST Series™ are meant for a wider range of indications by including a signal modeled on that of the Bionicare BIO-1000 predicate device. The ST-150 is otherwise identical with the ST-100. The ST-200 offers two output channels and more user options. The ST-300 offers four channels, even more options, and is meant for use in a clinical setting only.
Technological Characteristics:
The technological characteristics of the MedRelief® ST Series™ are the same as those of the predicate devices. Each device is battery-powered with no provisions for line power or AC adapters. Each uses solid-state electronics to produce trains of subthreshold electrical pulses, at frequencies within the human audible range (~20 Hz to ~20 KHz), which are applied to the body through self-adhesive or gelled electrodes placed on the skin. Pulses have zero net charge and may be applied either continuously, or divided into pulse bursts alternating with quiet periods. All signal characteristics comply with the safety requirements of AAMI NS4.
Comparison of Features of MedRelief® ST Series™ Models
(s) - user switch selected. (c) - user adjustable through continuous range.
| Characteristic or Feature | ST-100 | ST-150 | ST-200 | ST-300 |
|---|---|---|---|---|
| Intended use | Intractable chronic, postsurgical / posttraumatic acute and arthritis-related pain. | |||
| Intended sale | Prescription only | |||
| Number of output | ||||
| channels | 1 | 1 | 2 | 4 |
| Pulse frequency | 700, 1800 or | |||
| 4150 Hz (s) | 100, 700 or | |||
| 4150 Hz (s) | 100, 230, 700,1800, 4150 | |||
| Hz or 12 KHz (s) | 100 Hz to 20 | |||
| KHz (c) | ||||
| Pulse (short phase) length | 1/7 of long phase or 20 microseconds, whichever is greater | |||
| Burst frequency | 15 Hz in pulse burst mode; N/A in continuous mode. | |||
| Burst duty cycle | 15% or 100%* (s) | 5% up to 100%* (c) | ||
| Timer | None (runs whenever turned on) | 30 min., 8 hrs or cont. (s) | ||
| Dimensions, in. | 2.5 x 2.1 x 0.63 | 3.5 x 2.5 x 1 | 7 x 5 x 2.5 | |
| Weight including battery | 1.7 oz. | 2.5 oz. | 8 oz. | |
| Charger, AC cord or | ||||
| adapter? | None |
- Burst duty cycle of 100% = continuous operation.
2
y 3. 4
Comparison of General and Technical Characteristics to Predicates.
Electrical output measurements assume a 500-ohm load. Timing values cited below are accurate to ±20% or 10 microseconds, whichever is larger. Other cited values are accurate to ±20% unless otherwise stated.
For conciseness, (10), (15), (20) and (30) refer to the ST-100, ST-150, ST-200 and ST-300 respectively. "Same" plus one or more of these labels in a Predicate column means "same as in the indicated ST Series™ device(s)," while without a label it means "same for all." See also notes 1-3 at the bottom of the table.
| Unit Characteristic | Proposed Device | Predicate #1 | Predicate #2 |
|---|---|---|---|
| Device name and model | MedRelief® ST Series | ||
| (ST-100, ST-150, ST-200 and ST-300) | MedRelief® SE-50 | ||
| (in SE Series). | BioniCare® | ||
| Stimulator, Model | |||
| BIO-1000™ | |||
| Manufacturer | Healthonics, Inc. | ||
| 903 Main Street South | |||
| New Ellenton, SC 29803 | Same. | BioniCare Medical | |
| Technologies, Inc. | |||
| 47 R. Loveton Circle | |||
| Sparks, MD 21152 | |||
| 510(k) number | To be assigned | K030998 | K030332, K983228 |
| Procode | GZJ, NYN | GZJ | NYN |
| Intended Use | |||
| (indications; abbreviated, | |||
| see full list above.) | 1. Chronic intractable pain. |
- Post-surgical/post-traumatic acute
pain. - Pain/symptoms from osteoarthritis
of the knee. - Pain/stiffness from rheumatoid
arthritis of the hand. | Same as #1 and #2
for proposed device. | Same as #3 and #4
for proposed device |
| Number of output
modes | One: subthreshold
TENS. | Same. | Same. |
| Number of output
channels. | One (10, 15), two (20), or four (30). | One. | Version A: one.
Version B: two. |
| Pulse shape | Rectangular to exponential,
depending on pulse length and
charge balancing time chosen. | Same. | One phase
exponential, other
phase rectangular. |
| Mono- or biphasic | Biphasic | Biphasic | Biphasic (note 1) |
| Maximum instantaneous
current | 8.62 mA | Same | 24 mA |
| Maximum time averaged
current | 2.27 mA (2.71 mA, note 2) | Same | 2 mA |
| Maximum phase charge | 12.4 µC at 100 Hz;
1.87 µC at 700 Hz (note 2) | 1.87 µC at 700 Hz
(note 2) | 20 µC at 100 Hz |
| Maximum current density
at electrode | 0.41 mA/sq.cm. (note 2) | Same | 0.14 mA/sq.cm.
(note 3) |
| Maximum power density
at electrode | 0.133 mW/sq.cm. (note 2) | Same | 0.83 mW/sq.cm.
(note 3) |
| Regulated current or
regulated voltage? | Regulated current. | Same. | Regulated voltage. |
| Software/ firmware/
/microprocessor control? | No | No | No in Version A; yes
in Version B. |
| Housing materials and
construction. | Flame-retardant ABS plastic. | Same. | Flame-retardant
Cycolac plastic |
| Accessories: - Electrodes. | Pregelled reusable electrode,
25 cm² gel area, with "pigtail" wire
connection. For 100 Hz use (15, 20,
30), same but with 175 cm² gel area. | Pregelled reusable
electrode, 25 cm² gel
area, with "pigtail"
wire connection. | BioniCare special
design, metal mesh,
170-176 cm² gel-
coated area. |
| 2. Conductive
medium (gel) | None | None | Spectra 360 |
3
Applicant: Healthonics, Inc.
x 4:4
| 3. Electrode lead
wires. | 2 mm pin joined to 2mm socket by
flexible wire | Same. | Semicustom wires,
snap connectors |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------|-----------------------------------------|
| 4. Batteries. | 9V lithium batteries: miniature
semicustom (10, 15, 20) ; standard
rectangular (30). | Same (10, 15, 20) | Self-contained
rechargeable battery. |
| 5. Battery charger,
if used. | None. | None. | Plug-in wall
transformer type |
| Note 1. BioniCare claims monophasic pulses, but Healthonics scope measurements show the second phase is not
completely suppressed so the BioniCare pulses are actually biphasic.
Note 2: Taken under conservative worst-case conditions including any single-component failure. | | | |
:
:
:
Note 3. Healthonics measured from predicate device or calculated from information in predicate's 510(k).
.
.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol consists of three human profiles facing right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 2006
Healthonics, Inc. % Mr. James W. Kronberg Chief Engineer 903 Main Street South New Ellenton, South Carolina 29809
Re: K060669
Trade Name: MedRelief ST ("Sub-Threshold") Series consisting of model numbers ST-100. ST-150, ST-200, and ST-300 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: GZJ, NYN Dated: September 13, 2006 Received: September 14, 2006
Dear Mr. Kronberg:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Pegister.
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 not mour 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.
5
Page 2 - Mr. James W. Kronberg
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Melkonian
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
510(k) number (if known): ___K060669
Device Name: MedRelief ST ("Sub-Threshold") Series, consisting of model numbers ST-100, ST-150, ST-200 and ST-300.
Indications for 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. .
| Prescription Use
(21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart D) |
| -------------------------------------------- | -------- | ------------------------------------------------ |
|---|
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | L060669 |
|---|---|
| --------------- | --------- |