(52 days)
Not Found
No
The summary describes a conductive garment for TENS therapy and electrode placement, with no mention of AI or ML capabilities.
Yes
The device is intended for symptomatic relief and management of chronic pain, which is a therapeutic function. It is used in conjunction with TENS, a recognized therapeutic modality.
No
The device is described as providing symptomatic relief and assisting in the positioning of electrodes for TENS. It does not mention detection, diagnosis, or assessment of a medical condition.
No
The device description explicitly states that the device includes a conductive belt and electrodes, which are hardware components.
Based on the provided information, the Lumbofix® Conductive Garment is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Lumbofix® Function: The Lumbofix® Conductive Garment is a physical garment used externally on the body. Its function is to facilitate the application and positioning of electrodes for Transcutaneous Electrical Nerve Stimulation (TENS) therapy, which is a non-invasive method for pain relief. It does not analyze any biological samples.
The intended use and device description clearly indicate its role in supporting TENS therapy for pain management, which is an external therapeutic application, not an in vitro diagnostic process.
N/A
Intended Use / Indications for Use
The Lumbofix® Conductive Garment provides symptomatic relief and management of chronic and intractable pain in the lower back region and assists in the frequent and correct positioning and repositioning of pads on difficult to reach and/or large locations of the lower back. It is intended for prescription use only.
Product codes
GZJ
Device Description
The Lumbofix® Conductive Garment is a conductive garment intended for use in conjunction with transcutaneous electrical nerve stimulation (TENS). It aids in the placement of electrodes and secures them in place. Contents include a conductive belt, a pack of hook backed electrodes and instructions for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back region
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)
No new clinical studies have been submitted as part of this premarket notification.
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
Image /page/0/Picture/0 description: The image shows a logo with the letters "BMR" in a stylized font. The letters are arranged horizontally, with a curved line above and below them. The logo has a textured appearance, as if it were printed on a rough surface. The logo is simple and modern, and it would be suitable for a variety of businesses or organizations.
+353 (0)91 774300 Fax: +353 (0)91 774301
99121
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92
1. Contact Details
| Name: | Anne-Marie Keenan |
|---|---|
| Address: | Bio-Medical Research Ltd., |
| Parkmore Business Park, West | |
| Galway, Ireland | |
| Telephone: | +353 91 774300 |
| Fax: | +353 91 774301 |
| E-Mail: | akeenan@bmr.ie |
| Prepared: | 30th April 2009. |
2. Device Name
| Trade Name of Device: | Lumbofix® Conductive Garment, Type 420 Back |
|---|---|
| Common Name: | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Classification: | Class II |
| Product Code: | G̀ZJ |
3. Identification of Equivalent Legally Marketed Device
| Device Trade Name: | Baxolve XP Conductive Garment Accessory & Lumbar
Support Kit |
|--------------------|-----------------------------------------------------------------|
| Manufacturer: | Bio-Medical Research Ltd |
| 510(k) No: | K082190 |
4. Description of Device
The Lumbofix® Conductive Garment is a conductive garment intended for use in conjunction with transcutaneous electrical nerve stimulation (TENS). It aids in the placement of electrodes and secures them in place. Contents include a conductive belt, a pack of hook backed electrodes and instructions for use.
1
5. Indications for Use
The Lumbofix® Conductive Garment provides symptomatic relief and management of chronic and intractable pain in the lower back region and assists in the frequent and correct positioning and repositioning of pads on difficult to reach and/or large locations of the lower back. It is intended for prescription use only.
6. Technological Characteristics
There are no new technological characteristics that could affect safety or effectiveness of the Lumbofix® Conductive Garment. Substantial Equivalence has been demonstrated as part this 510k submission.
7. Clinical and Non-Clinical Tests
Bio-Medical Research 1.td. ("BMR") has over 30 years experience in the research, design, manufacture and marketing of medical grade products for both muscle strengthening and pain relief. Bio-Medical Research Ltd. (Slendertone & Neurotech) complies with 21 CFR 820 and is registered to I.S. EN ISO 13485:2003 Medical Device Quality Management System for the design, manufacture and distribution of electro-medical devices.
No new clinical studies have been submitted as part of this premarket notification. The Lumbofix® Conductive Garment has been CE marked under the EU Medical Device Directive 93/42/EEC (NB No. 0366).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right side.
Public Health Service
JUN 25 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bio-Medical Research Ltd c/o Ms. Anne-Marie Keenan Quality/Regulatory Engineer Parkmore Business Park West Galway Ireland
Re: K091317
Trade Name: Lumbofix® Conductive Garment, Type 420 Back Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: April 30, 2009 Received: May 28, 2009
Dear Ms. Keenan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your coetermined the device is substantially equivalent (for the indications forcronood above and in rise enclosure) to legally marketed predicate devices marketed in interstate 101 too surver in the May 28, 1976, the enactment date of the Medical Device Amendments, or to eoninored prior of ride 2011-11-2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic (110-) the researce, subject to the general controls provisions of the Act. The r ou may, merelore, maines of the Act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is classifical controls. Existing major regulations affecting your device can be finay be subject to cademical Regulations, Title 21, Parts 800 to 898. In addition, FDA may round in the over of concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Toast of advised that 1 Dris assumes over device complies with other requirements of the Act that I Dr has intact a and regulations administered by other Federal agencies. You must or any I cacal statuted und regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CITY art 607); idocing (21 OFR 803); good manufacturing practice requirements as set device-related daverse ovents) (21 CFR Part 820); and if applicable, the electronic form in the quant) systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Anne-Marie Keenan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Keira Alexander for
Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name:
Lumbofix® Conductive Garment
Indications for Use:
The Lumbofix® Conductive Garment:
- 『 provides symptomatic relief and management of chronic and intractable pain in the lower back region and
- assists in the frequent and correct positioning and repositioning of pads on difficult to . reach and/or large locations of the lower back.
Prescription Use X (Part 21 CFR 801 Subpart D)
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)
Dexter 6/24/09
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number ___$\qquad$ K091317