(251 days)
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No
The provided text describes a medical device that uses various stimulation and ultrasound modalities for therapeutic purposes. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections. The device appears to be a traditional physical therapy device.
Yes
The "Intended Use / Indications for Use" section explicitly lists several therapeutic applications such as "Relaxation of Muscle Spasms," "Symptomatic relief or management of chronic, intractable pain," "Stroke rehab by muscle re-education," and "Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions."
No.
The "Intended Use / Indications for Use" section primarily describes therapeutic applications such as relaxation of muscle spasms, pain relief, muscle re-education, and increasing blood circulation, which are treatment-oriented. While EMG is mentioned for "determination the activation timing of muscles," this is described in the context of re-education and training, not for disease or condition diagnosis.
No
The intended use and anatomical sites clearly indicate this device is a physical stimulator and ultrasound device, which are hardware-based modalities, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended uses listed for this device involve applying electrical stimulation and ultrasound directly to the patient's body for therapeutic purposes (muscle stimulation, pain relief, etc.). There is no mention of analyzing biological samples like blood, urine, or tissue.
- The device description (though not found) and intended uses clearly point to a physical therapy or rehabilitation device. The modes like VMS, TENS, FES, EMG, and Ultrasound are all modalities used for treating conditions within the body, not for diagnosing conditions by analyzing samples.
Therefore, this device falls under the category of a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS):
Relaxation of Muscle Spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS):
Symptomatic relief or management of chronic, intractable pain
Post-traumatic acute pain
Post-surgical acute pain
For FES:
Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait
For DC Continuous Mode:
Relaxation of muscle spasm
For EMG:
To determination the activation timing of muscles for:
a) retraining of muscle activation
b) coordination of muscle activation
An indication of the force produced by muscle for control and maintenance of muscle contractions
Relaxation muscle training
Muscle re-education
For EMG triggered Stim:
Stroke rehab by muscle re-education
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increase local blood circulation
Muscle re-education
Maintaining or increasing range of motion
For Ultrasound:
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
- Relief of pain, muscle spasms and joint contractures
- Relief of pain, muscle spasms and joint contractures that may be associated with:
a) Adhesive capsulitis
b) Bursitis with slight calcification
c) Myositis
d) Soft tissue injuries
e) Shortened tendons due to past injuries and scar tissues - Relief of sub-chronic and chronic pain and joint contractures resulting from:
a) Capsular tightness
b) Capsular scarring
Product codes
IMG, GZJ, IPF, HCC, GZI, LIH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 - 2004
Ms. Cheryl Bagwell Director of Regulatory Affairs Chattanooga Group A Division of Encore Medical 4717 Adams Road P.O. Box 489 Hixson, Tennessee 37343-0489
Re: K031077
Trade Name: Vectra GENiSYS Regulation Numbers: 21 CFR 890.5860, 882.5890, 890.5850, 882.5050, 882.5810 Regulation Names: Ultrasound and muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator, Biofeedback device, External functional neuromuscular stimulator Regulatory Class: II Product Codes: IMG, GZJ, IPF, HCC, GZI
Trade Name: Vectra GENiSYS Regulation Number: Unclassified Regulation Name: Interferential current therapy stimulator Regulatory Class: II Product Code: LIH
Dear Ms. Bagwell:
:
This letter corrects our substantially equivalent letter of December 11, 2003 regarding the Vectra GENiSYS Indications for use enclosure.
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.
1
Page 2 - Ms. Cheryl Bagwell
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 Register.
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); 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 1000-1050. 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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely vo
Mark A Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K031077 Vectra GENiSYS (Intelect Legend XT) Device Name:
Indications for Use: (Page 1 of 2)
For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS)
Relaxation of Muscle Spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS)
| Symptomatic relief or management of chronic, intractable pain |
|---|
| Post-traumatic acute pain |
| Post-surgical acute pain |
For FES
Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait
For DC Continuous Mode
Relaxation of muscle spasm
For EMG
To determination the activation timing of muscles for:
- a) retraining of muscle activation
- b) coordination of muscle activation
An indication of the force produced by muscle for control and maintenance of muscle contractions
Relaxation muscle training
Muscle re-education
노르트워크로드오 노르드루비스
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
Prescription Use (Per 21 CFR 801.109)
OR
KO31077 510 Ry Ninnberter Use
(Optional Format 1-2-96)
3
510(k) Number (if known): K031077 Vectra GENiSYS (Intelect Legend XT) Device Name:
Indications for Use: (Page 2 of 2)
| For EMG triggered Stim |
|---|
| Stroke rehab by muscle re-education |
| Relaxation of muscle spasms |
| Prevention or retardation of disuse atrophy |
| Increase local blood circulation |
| Muscle re-education |
| Maintaining or increasing range of motion |
For Ultrasound
(Per 21 CFR 801.109)
| Application of therapeutic deep heat for the treatment of selected sub-chronic and | |
|---|---|
| chronic medical conditions such as: | |
| 1. Relief of pain, muscle spasms and joint contractures | |
| 2. Relief of pain, muscle spasms and joint contractures that may be associated | |
| with: | |
| a) Adhesive capsulitis | |
| b) Bursitis with slight calcification | |
| c) Myositis | |
| d) Soft tissue injuries | |
| e) Shortened tendons due to past injuries and scar tissues | |
| 3. Relief of sub-chronic and chronic pain and joint contractures resulting from: | |
| a) Capsular tightness | |
| b) Capsular scarring |
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE JE EDED) Concurrence of CDRH, Office of Device aluatio (Di ision Sign-Off) Division of General, Restorative, and Neurological Devices K031077 Prescription Use Over 1948 Status Post OR
(Optional Format 1-2-96)