(90 days)
Missing K/DEN number in the provided text.
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, or related concepts like image processing, deep neural networks (DNNs), or descriptions of training/test sets typically associated with AI/ML development. The intended uses are standard for electrical muscle stimulation devices.
Yes
The device is indicated for relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, muscle re-education, post-surgical stimulation to prevent venous thrombosis, and maintaining or increasing range of motion, all of which are therapeutic applications.
No
The provided 'Intended Use / Indications for Use' lists therapeutic applications like muscle relaxation, atrophy prevention, circulation increase, and range of motion maintenance. It does not mention any diagnostic functions such as detection, diagnosis, or monitoring of conditions.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The listed indications for use (muscle stimulation, etc.) strongly suggest a hardware component is involved to deliver the therapy, but without a description, this cannot be confirmed.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The listed intended uses (muscle relaxation, preventing atrophy, increasing circulation, muscle re-education, post-surgical stimulation, maintaining range of motion) are all related to physical therapy and rehabilitation, directly acting on the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function appears to be therapeutic or rehabilitative.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's intended uses do not align with this definition.
N/A
Intended Use / Indications for Use
THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :
- Relaxation of muscle spasms 1.
- Prevention or retardation of disuse atrophy 2.
- Increasing local blood circulation 3.
- 4 . Muscle re-education
-
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
-
- Maintaining or increasing range of motion
Product codes
IPF
Device Description
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
AUG 0 6 2002
C. A. Teklinski Home Medical Services 9393 Activity Road. Suite F San Diego, California 92126
K021472 Trade/Device Name: HMS-DHR-3 Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: May 6, 2002 Received: May 8, 2002
Dear Mr. Teklinski:
Re:
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 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 (OS) regulation (21 CFR Part 820); and if
1
Page 2 -- C. A. Teklinski
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Mark N. Millican
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
HMS-DHR-3 NEUROMUSCULAR STIMULATOR
INDICATIONS FOR USE
THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :
- Relaxation of muscle spasms 1.
- Prevention or retardation of disuse atrophy 2.
(510 (k)
- Increasing local blood circulation 3.
- 4 . Muscle re-education
-
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
-
- Maintaining or increasing range of motion
Mark N Millican
Division Sign T) ision of General, Restorative and Neurological Devi
510(k) Number.