(170 days)
Not Found
No
The document describes a traditional neuromuscular and TENS stimulator with pre-programmed operating modes stored in internal memory. There is no mention of AI, ML, or any learning or adaptive capabilities.
Yes
The device is indicated for various therapeutic benefits such as relaxation of muscle spasms, prevention of muscle disuse atrophy, increasing local blood circulation, muscle re-education, prevention of venous thrombosis, maintaining/increasing range of motion, and symptomatic pain relief.
No.
The device description and intended use indicate that the VEINOPLUS® Neuromuscular Stimulator is used for therapeutic purposes like muscle stimulation and pain relief, not for diagnosing medical conditions.
No
The device description explicitly states it is a "traditional battery powered muscle stimulator" and a "single channel device," indicating it is a hardware device with internal memory for operating modes.
Based on the provided information, the VEINOPLUS® Neuromuscular Stimulator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- VEINOPLUS® Function: The VEINOPLUS® is a neuromuscular stimulator and TENS device. It applies electrical stimulation directly to the body (muscles and nerves) for therapeutic purposes (muscle relaxation, atrophy prevention, circulation increase, pain relief, etc.). It does not analyze any biological specimens.
Therefore, the VEINOPLUS® falls under the category of a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The VEINOPLUS® Neuromuscular Stimulator is indicated for the following:
In the Primary Mode of Action (PMOA) when the Operating Mode number 1 for muscle stimulation is activated, the Indications for Use are:
- · Relaxation of muscle spasms.
- · Prevention or retardation of muscle disuse atrophy.
- · Increasing local blood circulation.
- · Muscle re-education.
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Maintaining or increasing range of motion.
In the other Mode of Action (MOA), when the Operating Mode number 2 for Transcutaneous Electrical Nerve Stimulation (TENS) stimulation is activated, the Indication for Use is :
· Providing symptomatic pain relief for chronic, acute or post operative pain.
Product codes
89 IPF and GZJ
Device Description
The VEINOPLUS® Neuromuscular Stimulator is a traditional battery powered muscle stimulator and it is combined with the TENS stimulator. It is a single channel device with its Operating Modes stored in the internal memory. The VEINOPLUS® provides two separate and switchable independent Operating Modes of stimulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
§ 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
Image /page/0/Picture/0 description: The image shows the logo for Ad Technology. The logo consists of a stylized eye symbol on the left, followed by the words "Ad" in a larger font size. Below "Ad" is the word "TECHNOLOGY" in a smaller, all-caps font. The logo is simple and modern, with a focus on the company's name and its association with technology.
162, rue du Fbg Saint Honoré 75008 Paris, France Tél : +33 (0)1 42 60 00 22 Fax: +33 (0)1 42 60 00 63 info@adremtechnology.com
SUMMARY OF SAFETY AND EFFECTIVENESS
ADMINISTRATIVE INFORMATON 1-0
SPONSOR IDENTIFICATION (510(k) OWNER) 1-1 AdRem Technology JAN 30 2003 162 rue du Fauburg St. Honore PARIS Postal Code 75012 France Mr. Olivier Huon, Chief Executive Officer Mr. Thierry Tavidian, President Telephone 011-331-4260 0022 Fax 011-331-4260 0063 tt@adremtechnology.com oh@adremtechnology.com 1-2 ESTABLISHMENT REGISTRATION NUMBER: Pending OFFICIAL CONTACT PERSON / OFFICIAL 1-3 CORRESPONDENT / AGENT Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, MD 20854 estrin@yourFDAconsultant.com Tel: (301) 279 -2899 Fax: (301) 294-0126 DATE OF PREPARATION OF THIS SUMMARY 1-4 August 9 2007 । -- PROPRIETARY (TRADE) NAME VEINOPLUS® Neuromuscular Stimulator
1-6 COMMON NAME
Muscle Stimulator, Neuromuscular Stimulator, NMS, EMS (when used in Mode 1); Nerve Stimulator, TENS, Pain Control Stimulator (when used in Mode 2)
0012
1
SARL au CAPITAL 123 970€ - APE514S - TVA : FR70 453 317 265 - RCS PARIS B 453 317 265
1
1-7 CLASSIFICATION NAME
Powered muscle stimulator; Stimulator, nerve, transcutaneous, for pain relief
- 1-8 REGULATION NUMBERS: 21 CFR 890.5850; 21 CFR 882.5890
- 1-9 PROPOSED REGULATORY CLASS: Class 2
- 1-10 DEVICE PRODUCT CODES: 89 IPF and GZJ
- 1-11 MEDICAL SPECIALTIES: Physical Medicine; Neurology
2-0 DESCRIPTION OF DEVICE
The VEINOPLUS® Neuromuscular Stimulator is a traditional battery powered muscle stimulator and it is combined with the TENS stimulator. It is a single channel device with its Operating Modes stored in the internal memory. The VEINOPLUS® provides two separate and switchable independent Operating Modes of stimulation.
3-0 INDICATIONS FOR USE:
The VEINOPLUS® Neuromuscular Stimulator is indicated for the following:
In the Primary Mode of Action (PMOA) when the Operating Mode number 1 for muscle stimulation is activated, the Indications for Use are:
- · Relaxation of muscle spasms.
- · Prevention or retardation of muscle disuse atrophy.
- · Increasing local blood circulation.
- · Muscle re-education.
· Immediate post-surgical stimulation of calf muscles to
prevent venous thrombosis
- · Maintaining or increasing range of motion.
In the other Mode of Action (MOA) when the Operating Mode number 2 for Transcutaneous Electrical Nerve Stimulation (TENS) stimulation is activated. the Indications for Use are:
· Providing symptomatic pain relief for chronic, acute or post operative pain.
4-0 PREDICATE DEVICES
K022175 Trade/Device Name: VALMED P4-PHYSIO. Regulation Number: 21 CFR 890.5850
00013
2
Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF The equivalence is claimed only for the Operational Mode number 1 of the VEINOPLUS®
K040253 Trade/Device Name: EASYMED TN-28C T.E.N.S. Unit Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ The equivalence is claimed only for the Operational Mode number 2 of the VEINOPLUS®
ર-0 SUBSTANTIAL EQUIVALENCE
The VEINOPLUS® Neuromuscular Stimulator is substantially equivalent to the VALMED P4-PHYSIO (K022175) in mode number 1 (neuromuscular stimulation) and to the EASYMED TN-28C T.E.N.S. Unit (K040253) in mode number 2 (TENS stimulation). Both VEINOPLUS®, the VALMED P4-PHYSIO the EASYMED TN-28C T.E.N.S. Unit comply with the Voluntary Standards: ANSI/AAMI NS4-1985, IEC 60601-2-10, PART 2 and MDD 93/42/EEC and to 21 CFR § 898.
6.0. CONCLUSION
The AdRem VEINOPLUS® Neuromuscular Stimulator meets appropriate standards and raises no safety/efficiency issues or claims that differ from the predicate device cited.
000014
000346
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
JAN 30 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AdRem Technology SARL % Estrin Consulting Group, Inc. Dr. Norman Estrin 9109 Copenhaven Drive Potomac, MD 20854
Re: K072252
Trade/Device Name: Veinoplus Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: December 11, 2007 Received: December 21, 2007
Dear Dr. Estrin:
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 (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.
4
Page 2 - Dr. Norman Estrin
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Trade/Proprietary Name: VEINOPLUS® Neuromuscular Stimulator
Indications for Use:
The VEINOPLUS® Neuromuscular Stimulator is indicated for the following:
In the Primary Mode of Action (PMOA) when the Operating Mode number 1 for muscle stimulation is activated, the Indications for Use are:
- · Relaxation of muscle spasms.
- · Prevention or retardation of muscle disuse atrophy.
- · Increasing local blood circulation.
- · Muscle re-education.
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Maintaining or increasing range of motion.
In the other Mode of Action (MOA), when the Operating Mode number 2 for Transcutaneous Electrical Nerve Stimulation (TENS) stimulation is activated, the Indication for Use is :
· Providing symptomatic pain relief for chronic, acute or post operative pain.
Page 1__ of_1__
December 13, 2003) ___________________________________________________________________________________________________________________________________________________________
| Prescription Use
(Part 21 CFR 801 Subpart D) | X AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| ------------------------------------------------- | ---------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | 1072257 |
|---|---|
| --------------- | --------- |
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