BODY CLOCK STIMPLUS AND STIMPLUS PRO

{0}------------------------------------------------ KC41354 # AUG 2 0 2004 # 10 510(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: _______________________________________________________________________________________________________________________________________________ # 10.1 Submitter's Identification: Body Clock Health Care Ltd 108 George Lane South Woodford London E18 1AD United Kingdom Tel: +44 (0)20 8532 9551 Fax: +44 (0)20 8532 9551 Rashelle Preston Contact: 18 May 2004 Date Prepared: # 10.2 Name of Device: #### Proprietary Name: - Body Clock Stimplus Pro 1. - II. Body Clock Stimplus # Common or Usual Name: TENS unit (Transcutaneous Electrical Nerve Stimulator) #### Classification Name: Stimulator, Nerve, Transcutaneous, For Pain Relief. #### 10.3 Predicate Device Information: The Body Clock Stimplus Pro is identical to the Solitens Modified (Stimplus Pro) (K913522) The Body Clock Stimplas is very similar to the Solitens Modified (Stimplus Pro) (K913522) #### 10.4 Device Description: The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of the pain signal travelling to the brain. {1}------------------------------------------------ ### 10.5 Intended Use: TENS is used for the symptomatic relief and management of chronic intractable pain and/or as TENS is used for the symptomatio roller and wants of post-traumatic acute pain. # 10.6_Technological Comparison to Predicate Device: The Body Clock Stimplus Pro is identical to the predicate device (the Solitens Modified -The Body Olock Othinblus is very similar to the predicate device and has Rorrouze). The Bouy Choics that are substantially equivalent to the predicate device. Each of the units is made from the same mould and feature the same number of function Each or the units is made them the edentical, namely the Intensity Switch, the Power Switch, Switches. The fancilent and the Time Selector Switches. The timer selection on the units differ the Ulinbladel. On the Body Clock Stimplus Pro and predicate device, the user can choose to very cally 15 seconds or 30 seconds. On the Body Clock Stimplus, the user can choose between manual, 30 seconds and 60 seconds. Both units also have switches providing the user with adjustable stimulation control. On the predicate unit and Body Clock Stimplus Pro is the Frequency Switch. On the Body Clock Stimplus, there is a Rhythm Switch. Each of the units have their remaining features in common, including a low battery indicator, stimulation switch and LED display on the tope of the unit, passive contact plate and battery compartment on the underside of the unit and gold plate tip. In essence the predicate device oon the Body Clock Stimplus Pro are almost identical to the Body Clock Stimplus and are technically substantially equivalent. # 10.7 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." - 150 9002 . - ISO 13488 . - EN 46002 . - EN 60601-1-2:1993 (EEC Directive 89/336/EEC) . - IEC 601-1:1988 + A1:1991 + A2:1995 . - EN60601-1:90 + A1:93 + A2:95 + A13:96 . # 10.8 Clinical Testing: Not Applicable as there are no new or innovative aspects that have been introduced. #### 10.9 Conclusions: The Body Clock Stimplus Pro and the Body Clock Stimplus have the same intended use and similar technical characteristics to the Solitens Modified (Stimplus Pro) (K913522). The information supplied in this 510(k) illustrate that the device does not pose any new questions of safety and effectiveness. The Body Clock Stimplus is substantially equivalent to the predicate device. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows a logo with three stylized birds in flight, arranged diagonally from the upper right to the lower left. The birds are depicted with simple, curved lines, suggesting movement and freedom. The birds are enclosed within a partial circle, which appears to be a border or frame for the logo. The logo has a minimalist design, focusing on the essence of flight and nature. AUG 2 0 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Rashelle Preston Director of Special Projects Body Clock Health Care Ltd 108 George Lane South Woodford London E18 1AD England Re: K041359 K041339 Trade/Device Name: Body Clock Stimplus and Body Clock Stimplus Pro Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: May 18, 2004 Received: May 21, 2004 Dear Ms. Preston: We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 910(x) premained instantially equivalent (for the indications referenced and nave uctchilliou the devices marketed predicate devices marketed in interstants for use stated in the encrosule) to regally manation in the Medical Device American so Love Hised. Prus commerce prior to May 28, 1770, the enatified in accordance with the provisions of the Federal Food. Drug. devices that have been reclassified in accerdance while a preval application (PMA). and Cosmetic Act (Act) that do not require approval of a previous at the Act . The and Cosment Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, subject to the generation, liging of You may, therefore, market the devices sayser of the manual registration, listing of general controls provisions of the Act include requirements for annual registration and general controls provisions of the Fee netals readers reading misbranding and adulteration. If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) me) eising major regulations affecting your device can may be subject to such additional controls. Existing major and conditions Fif may be subject to such additional controlise 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 docs not mean Please be advised that FDA s issuated or a belevice complies with other requirements of the Act emplies made a determination that your device complies with other requirements that FDA has made a decermination administered by other Federal agencies. You must of any redelal statues and regulations and manadine, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set C. F. Part 807), tabeling (21 CFR Part 820), good manat 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin nationing your article quisalence of your device to allegally prematice to wheation. The FDA finding of substantial and this permits vour premarket in the rive 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 rs the list of the same on the compares and 160 methose note the requiried If you desire specific advice for your de needed on the see note the regulation entitled, contact the Office of Compliance at (301) 597 1007 (21CFR Part 807.97). You may obtain "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obt "Misbranding by reference to premarkst nothleadon (or or on the Division of Small) other general information on your responsibilities under the Act from the 1800 638-200 other general information on your responsible and its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance at its toll-ifrememain html Manufacturers, International and Consumer Priseibults and views and main.html Sincerely yours, Sincerely yours, Mark N. Milken 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 8 510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________ Device Name/s: Body Clock Stimplus Pro Body Clock Stimplus # Indications For Use: The Body Clock Stimplus Pro and Body Clock Stimplus are used for the symptomatic relief The Bouy Clock Stimplus FTO und Dody Orean Strilland as an adjunctive treatment in the and management of post-surgical and post-traumatic acute pain. Mark A. Milken Division of General, Restorative, and Neurological Devices 510(k) Number PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number _ Prescription Use X (Per 21 CFR 801.109)