(435 days)
Not Found
No
The description details a standard TENS device with a microprocessor for control, but no mention of AI or ML capabilities for data analysis, pattern recognition, or adaptive learning.
Yes
The device is intended for the relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain, which are therapeutic applications.
No
The Quadra Bloc TENS Model 101 is described as a device for pain relief, a therapeutic function, not a diagnostic one. It does not mention any function for identifying or analyzing medical conditions.
No
The device description explicitly details hardware components including a battery compartment, display, keypad, electronic system, output channels, and a microprocessor. It is a physical, battery-powered device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a device that delivers electrical stimulation to the body for pain relief. It does not describe a device that analyzes samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening.
The Quadra Bloc TENS Model 101 is a therapeutic device used for pain management.
N/A
Intended Use / Indications for Use
The QuadraBloc TENS Model 101 is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
The Quadra Bloc TENS, Model 101 is a battery powered portable TENS device. The Quadra Bloc TENS, Model 101 is a prescription device that is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. The device is specially designed to be small, portable and lightweight so as to not interfere with users movements and/or functions. The electronics unit consists of a housing that contains a battery compartment, display, entry keypad, electronic system, and output channels.
The Quadra Bloc TENS, Model 101 uses four AA alkaline batteries. The display is a single line 16-character alphanumeric display. The entry keypad is used for turning the device on/off, setting parameters on the device and controlling operation. There are two output channels, designated Left and Right. They have a constant phase relation with each other but are independently set for amplitude. There is a separate two-wire cable for each channel. The electronics consists of a microprocessor (HP) to control and sequence all functions. It also reads the keyboard inputs. Output amplitude and display are under HP control. The electronics also boost the battery voltage to the level required for the stimulation pulse, as well as controls the timing for the pulse width and frequency. The QuadraBloc TENS + Electrode, to be used in conjunction with the QuadraBloc TENS Model 101 is a PMI electrode with an attached QuadraBloc permanent magnet.
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
prescription: device and should be used under continued medical supervision.
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): 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.
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.
Not Found
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).
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
501(k) Summary
OCT 2 0 2011
A. | General Information on Submitter |
---|---|
---- | ---------------------------------- |
Name: | Gradient Technologies, LLC |
---|---|
Address: | 6070 Poplar Avenue, Suite 600 Memphis, TN 38119 |
Telephone: | (901) 767-2384 |
Fax: | (901) 767-1782 |
Name of Contact Person: | John Townsend |
Date Summary Prepared: | February 21, 2007 |
- B. General Information on Device Trace Name: Quadra Bloc TENS, Model 101 Classification Name: Transcutaneous electrical nerve stimulator, for pan relief Product Code: GZJ
- C. Predicate Devices
The current QuadraBloc TENS Model 101 is identical to the original QuadraBloc TENS Model 101; the modification to the QuadraBloc TENS Model 101 is identical to the PMI electrode. The ComboCare 2000 TENS and the QuadraBloc TENS Model 101 are substantially equivalent.
- D. Description of the Device
The Quadra Bloc TENS, Model 101 is a battery powered portable TENS device. The Quadra Bloc TENS, Model 101 is a prescription device that is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. The device is specially designed to be small, portable and lightweight so as to not interfere with users movements and/or functions. The electronics unit consists of a housing that contains a battery compartment, display, entry keypad, electronic system, and output channels.
The Quadra Bloc TENS, Model 101 uses four AA alkaline batteries. The display is a single line 16-character alphanumeric display. The entry keypad is used for turning the device on/off, setting parameters on the device and controlling operation. There are two output channels, designated Left and Right. They
1
have a constant phase relation with each other but are independently set for amplitude. There is a separate two-wire cable for each channel. The electronics consists of a microprocessor (HP) to control and sequence all functions. It also reads the keyboard inputs. Output amplitude and display are under HP control. The electronics also boost the battery voltage to the level required for the stimulation pulse, as well as controls the timing for the pulse width and frequency. The QuadraBloc TENS + Electrode, to be used in conjunction with the QuadraBloc TENS Model 101 is a PMI electrode with an attached QuadraBloc permanent magnet.
Intended Use ﻧﻨﺎ
The Quadra Bloc TENS 101 is intended for use in relief of chronic intractable pain and adjunctive treatment of postsurgical or post-traumatic acute pain. This is a prescription : device and should be used under continued medical supervision.
- Technological Characteristics of Device Compared to Predicate Device-ﺖ
| Brand
Name | Model | Shape | Size | Surface
Area | FDA Number |
|---------------|-------|-------|-------|-----------------|------------|
| PMI | WF2 | Round | 2″x2″ | 2026mm | K070807 |
- V. Indications for Use Statement
510(k) Number: K102278/S1
Device Name: Quadra Bloc TENS Model 101
Indications for Use: Prescription The Quadra Bloc TENS Model 101 is intended for use in relief of chronic intractable pain and adjunction treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Gradient Technologies, LLC c/o Mr. John Townsend, President 6070 Poplar Avenue, Sixth Floor, Memphis, TN 38119
Re: K102278
Trade Name(s): Quadra Bloc TENS Model 101 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: October 17, 2011 Received: October 18, 2011
Dear Mr. Townsend:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
3
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Keiva Alexander
Malvina B. Eydelman, M.D.
Malvina B. Eydelman, 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
K102278 510(k) Number (if known):
Quadra Bloc TENS Model 101 Device Name:
Indications For Use:
The QuadraBloc TENS Model 101 is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision. (Part 21 CFR 801 Sub part D)
X Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sem.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
X102278 510(k) Number_________________________________________________________________________________________________________________________________________________________________