(266 days)
No
The document describes a standard TENS and Powered Muscle Stimulator device with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
Yes
The device is described as a TENS unit and a Powered Muscle Stimulator, both of which are intended for medical purposes such as pain relief, muscle stimulation, and relaxation of muscle spasms, fitting the definition of a therapeutic device.
No
The device is described as a TENS unit and a Powered Muscle Stimulator, both of which are therapeutic devices used for pain relief and muscle stimulation, not for diagnosing medical conditions.
No
The device description explicitly states it transmits electrical pulses through the skin, indicating it includes hardware components (electrodes, pulse generator) beyond just software.
Based on the provided information, this device 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Body Clock Duo is described as a TENS unit and a Powered Muscle Stimulator. Both of these functions involve applying electrical stimulation externally to the body for pain relief and muscle stimulation.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient.
The device's intended use and description clearly indicate it's an external electrical stimulation device, not an IVD.
N/A
Intended Use / Indications for Use
As a TENS unit, the Body Clock Duo is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
As a Powered Muscle Stimulator unit the Body Clock Duo is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:
- Relaxation of muscle spasms; ●
- Prevention or retardation of disuse atrophy; ●
- Increasing local blood circulation; ●
- Muscle re-education; ●
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and .
- Maintaining or increasing range of motion. ●
Product codes
IPF, GZJ
Device Description
The Body Clock Duo has two facilities, enabling it to function as both a TENS unit and as a Powered Muscle Stimulator. As a TENS unit, the Body Clock Duo transmits electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain. As a Powered Muscle Stimulator, the Body Clock Duo can be used to relax muscle spasms, prevent or retard disuse atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.
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
Not Applicable as there are no new or innovative aspects that have been introduced.
Key Metrics
Not Found
Predicate Device(s)
FUJI TENS 804SIII (K893874), Altoona EMS 400 (K913272)
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
MAY 2 0 2003
11 510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K022849
1.1 Submitter's Identification:
Body Clock Health Care Ltd 108 George Lane South Woodford London E18 1AD United Kingdom Tel: +44 (0)20 8532 9551 +44 (0)20 8532 9551 Fax:
Contact: Jonathan Bash August 16th 2002 Date Prepared:
1.2 Name of Device:
Proprietary Name: Body Clock Duo
Common or Usual Name: Transcutaneous Electric Nerve Stimulator and Powered Muscle Stimulator
Classification Name:
Stimulator, Nerve. Transcutaneous, For Pain Relief and Powered Muscle Stimulator.
1.3 Predicate Device Information:
The Body Clock Duo is substantially equivalent to the FUJI TENS 804SIII (K893874) and the Altoona EMS 400 (K913272).
Device Description:
The Body Clock Duo has two facilities, enabling it to function as both a TENS unit and as a Powered Muscle Stimulator. As a TENS unit, the Body Clock Duo transmits electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain. As a Powered Muscle Stimulator, the Body Clock Duo can be used to relax muscle spasms, prevent or retard disuse atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.
1
1.4 -Intended Use:
As a TENS unit, the Body Clock Duo is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
As a Powered Muscle Stimulator unit the Body Clock Duo is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:
- Relaxation of muscle spasms; ●
- Prevention or retardation of disuse atrophy; ●
- Increasing local blood circulation; ●
- Muscle re-education; ●
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and .
- Maintaining or increasing range of motion. ●
1.5 Technological Comparison to Predicate Devices:
The Body Clock Duo has basic technological characteristics that are substantially equivalent to the predicate device(s).
This unit uses dials to change the settings. It also uses shrouded patient cable connectors to comply with the FDA's Final Rule "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables."
1.6 Non-clinical Testing:
- All Units are fully CE marked i.e. compliant with EEC Directive 93/42/EEC Annex V. ● classified as "Internally powered Equipment Type BF. They are intended for continuous operation."
- SO 9002 ●
- ISO 13488 .
- EN 46002 ●
- EN 60601-1-2:1993 (EEC Directive 89/336/EEC) .
1.7 Clinical Testing:
Not Applicable as there are no new or innovative aspects that have been introduced.
1.8 Conclusions:
The information supplied in this 510(k) illustrates that the Body Clock Duo does not pose any new questions of safety and effectiveness. The Body Clock Duo is substantially equivalent to the predicate devices and has the same intended use and same technical characteristics as them.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design resembling an eagle or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2003
Mr. Jonathan Bash Director of IT and Special Projects Body Clock Health Care Ltd. 108 George Lane, South Woodford London, England United Kingdom E18 1AD
Re: K022849
Trade/Device Name: Body Clock Duo Regulation Number: 21 CFR 882.5890, 890.5850 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator Regulatory Class: II Product Code: IPF, GZJ Dated: March 20, 2003 Received: March 24, 2003
Dear Mr. Bash:
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
3
Page 2 – Mr. Jonathan Bash
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 yours.
Mark A. McKenna
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
4
Statement of Indications For Use రు
510 (k) Number (if known): K022849_
Device Name: Body Clock Duo
Indications For Use:
As a TENS unit, the Body Clock Duo is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
As a Powered Muscle Stimulator unit the Body Clock Duo is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:
-
- Relaxation of muscle spasms;
- Prevention or retardation of disuse atrophy; 2.
-
- Increasing local blood circulation;
-
- Muscle re-education;
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and ട്.
-
- Maintaining or increasing range of motion.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Mark A. Millman
ivision Sign-Division of General Neurological Devices 510(k) Number
Prescription Use × (Per 21 CFR 801.109)