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J3UN 26 2012eA%F510(k) SUMMARY-Mettler SYs*Stim 240, ME 240Submitter's Name: Mettler Electronics Corp.Address: 1333 South Claudina StreetAnaheim, CA 92805Telephone: 714-533-2221 x331714-635-7539Fax:Contact: Christina CayuelaOS/RA ManagerDate Prepared:September 29, 2011Revised copy : March 27, 2012Revised copy: May 23, 2012Revised copy: June 25, 2012Proposed Device Name:a. TRADE NAME: Sys*Stim 240b. CLASSIFICATION NAME: Powered Muscle Stimulator(890.5850), Transcutaneous Electrical Nerve Stimulator for painrelief (882.5890) and Infrared Lamp (890.5500)c. COMMON NAME: Combination Neuromuscular Stimulatorand Low Level Light Therapy devicePredicate Devices:a. TRADE NAME: Chattanooga Group's Vectra Genisys - 2channel electrotherapy systemb. 510(k) Number: (K031077)c. TRADE NAME: Mettler Electronic Corp.'s Laser Sys*Stim540, infrared lamp, therapeutic heating deviced. 510(k) Number: (K043586)

Description of Proposed Device:The new Sys*Stim@ 240 neuromuscular stimulator features ninediscrete waveforms designed to facilitate clinical versatility. Waveformsmay be combined with on-off programs for neuromuscular educationas well as frequency and amplitude modulation programs for optimalpain management.New touch-sensitive technology has been used to make starting atreatment easy. The high-resolution color display allows clinicians tomonitor all treatment parameters continuously. The patented MWheelTM provides easy navigation through all of the menus.Clinicians can add full-featured light therapy capabilities to theSys*Stim 240 by purchasing either the cluster or laser applicatorpackage. The laser applicator has an 80 mW, 785 nm, laser diode andthe cluster emits 500 mW at 600 and 950 nm. Applicator holders areprovided with each applicator and can be attached to the sides of theSys*Stim 240.Treatment protocols complete with electrode placement guidance allowclinicians to quickly program treatment parameters for their patients.There is even space to save special treatment protocols for eachwaveform and for light therapy.The Sys*Stim 240 has an optional battery pack so that clinicians cantake either electrical stimulation or light therapy to their patients. Acarrying case is also available which holds the units and all theaccessories necessary for therapy on the road.

1Kt3017PA1E -3 OfProposed Device Intended Use Statement:Indications for Medium Frequency (Russian), Biphasic, High Volt PulsedCurrent (HVPC), Interferential (4P) and Premodulated (2P3) waveforms" Relaxation of muscle spasms" Prevention or retardation of disuse atrophy" Increase local blood circulation* Muscle re-education" Maintaining or increasing range of motion" Immediate post surgical stimulation of calf muscles to prevent venousthrombosisAdditional Indications for Microcurrent, Interferential (4P3),Premodulated (2P), Biphasic, and TENS waveforms* Symptomatic relief and management of chronic, intractable pain* Post-traumatic acute paine Post-surgical acute painIndications for DC (Direct Current) Mode*Relaxation of muscle spasmThe laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:* Temporary increase in local blood circulation* Temporary relief of minor muscle and joint aches, pains and stiffness* Relaxation of muscles* Temporary relief of Muscle spasms* Temporary relief of minor pain and stiffness associated with arthritisBiocompatibility Certification: Electrodes to be provided with thisdevice are the same as those previously submitted since 1997 withMettler Electronics Corp. devices: Sonicator Plus 992/994 (K984142);Sys*Stim 226 (K964028); Sys*Stim 294 (K984114); and Sonicator Plus930 (K013192).Performance Testing: The Sys*Stim 240 has been certified for:" ITS certification for ETL and C-ETL Listing* Compliance with EMC, EN 60601-1 -2: 2001 and FCC's 47 CFR,FCC Sub Part 18* Compliance to IEC 60601-2-22: 2007* Compliance to IEC 60825-1: 2007* Compliance to IEC 62471: 2006* Compliance to EN60601-2-10, (IEC 601-2-1 0) 2001

Comparison Table for Sys StinkY46510K SubmissionSection 21. 510 K#2. Device Name3.Manufacturer4.Power SourceKSys*Stim 240Mettler ElectronicsK031077Vectra GenisysEncore Medical(Chattanooga Group)AC line or optional battery pack 10.8 VLithium IonYesLine Current IsolationPatient Leakage Current (pA)Normal condition (ac)78 (Less than 100 pA)Single fault condition (ac)78 (Less than 500 pA)5. Number Of Output Modes6. Channel(s)SynchronousReciprocalOther7. Constant Current8.Constant VoltageSoftware / Firmware IYesMicroprocessor Control9. Automatic Overload TripAutomatic Over Current Trip10. Automatic No Load Trip11. AutomaticShut Off12. Patient OverrideControl Method13. Indicator DisplayOn / Off StatusLow Battery IndicatorVoltage / Current Level14. Timer Display: (Stimulator)AC line or optional battery packYesLess thian 1009( one less output)Less than 500102Channel2 Channel1&21&2Yes1&21 YesWarning only, OvercurrentYesWarning only, Bad electrode contactYesYesYesYesPatient interrupt switchPatient interrupt switchYesYesYes0 -60 minutes for stimulationYesYesYes0 -60 minutesAuto based on dosage for light therapy15. StandardsISO 14971 :2000UL 60601 -1CSA C22.2 NO 601.1 -M90IEC/EN 60601-1IECIEN 60601-1 -2IECIEN 60601 -2-10MDD 931421EEC, Annex 1116. Compliance Yes4.5 lb 15.50 lb with Battery (Lighter wt)8Sin (H) x 8in (W) x13 in (L)7ABS PlasticABS Plastic21 CFR 89817. Weight (lbs.)18. Dimensions (in.) H xW xL19. Housing Materials &ConstructionSection 2, Comparison Table for Sys*Stim 240(May 2012)8.8 x11.375 x12.75F

Explanation of Differences on the Comparison Tablefor the Sys*Stim 240ItemMettlerS. Number of output modes99. Automatic Over Current TripYesWarning only,Overcurrent10. Automatic No Load TripYesWarning only,Bad electrodecontact17. Weight4.5 lbs.7 lbs.18. Dimensions8x Sx 138.8 x 11.375 x12.75Chattanooga10ExplanationMettler does not haveChattanooga's proprietaryVMS burstOn an error such as this one,Mettler chooses to stop alloutput in the interest ofpatient safety.Mettler chooses patientsafety, by requiring theclinician to fix the contactissue and then restart thesystem, to assure there areno excess outputs.Different design criteria, noeffect on functionDifferent design criteria, noeffect on function

DEPARTMENT OF HEALTH & HUMAN SERVICES9.4Public Health ServiceFood and Drug Administration10903 New Hampshire AvenueDocument Control Room -W066-G609Silver Spring, MD 20993-0002Mettler Electronics Corporation% Ms. Christina CayuelaQSIRA Manager1333 South Claudina StreetAnaheim, California 92805JUN 2 6 2012Re: K 113017Trade/Device Name: SYS*stim 240Regulation Number: 21 CFR 890.5850Regulation Name: Powered muscle stimulatorRegulatory Class: 11Product Code: IPF, ILY, GZJ, LLHDated: May 26, 201.2Received: June 04, 2012Dear Ms. Cayuela:We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. 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 11 (Special Controls) or class III (PMA), itmay be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898: In addition, FDA maypublish further announcements concerning your device in the Federal Regzister.

Page 2 - Ms. Christina CayuelaPlease be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050.If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasego to DRHOffices/ucm 15 809.htm forthe Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, pleasenote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go Problem/default.htm for the CDRI-' s Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet forYou/Industrv/default.htm.Sincerely yours,&YS2,L7r)Mark N. MelkersonDirectorDivision of Surgical, Orthopedicand Restorative DevicesOffice of Device EvaluationCenter for Devices andRadiological HealthEnclosure

Indications for Use510(k) Number (if known):Device Name:KI 13017Sys*Stimo 240, Model ME2401. Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current(HVPC), Interferential (4P) and Premodulated (2P3) waveforms* Relaxation of muscle spasms" Prevention or retardation of disuse atrophy* Increase local blood circulation* Muscle re-education* Maintaining or increasing range of motion" Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis2. Additional indications for Microcurrent, Interferential (4P), Premodulated (2P3),Biphasic and TENS waveforms* Symptomatic relief and management of chronic, intractable paine Post-traumatic acute paine Post-surgical acute pain3. Indications for DC (Direct Current) Mode*Relaxation of muscle spasm4. The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:* .Temporary increase in local blood circulation* Temporary relief of minor muscle and joint aches, pains and stiffness*Relaxation of muscles*Temporary relief of muscle spasms*Temporary relief of minor pain and stiffness associated with arthritisPrescription UseXOver-The-Counter UseAND/OR(Per 21 CFR 801 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)Concurrent of CDRH 0ffce of Devicval tion (ODE)Division of Surgical, Orthopedic,an8 Restorative Devices5. 0(k) NumberKI k

% Ms. Christina Cayuela QSIRA Manager 1333 South Claudina Street Anaheim, California 92805 Re: K 113017 Trade/Device Name: SYS*stim 240 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: 11 Product Code: IPF, ILY, GZJ, LLH Dated: May 26, 201.2 Received: June 04, 2012 Dear Ms. Cayuela: