Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- MiscellaneousMiscellaneous
- LDKDevice, Sensing, Optical ContourUProduct Code
- LWBStimulator, Functional Neuromuscular, Scoliosis3Product Code
- LXMManipulator, Plunger-Like JointUProduct Code
- LZWMonitor, Spine CurvatureUProduct Code
- MBQPeripheral Electromagnetic Field (Pemf) To Aid Wound Healing3Product Code
- MLYVapocoolant DeviceUProduct Code
- QPYStimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation3Product Code
- QWIComputerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms2Product Code
- SDOTranscutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation2Product Code
- SECWearable Fall Injury Prevention Device2Product Code
- Submissions with No Product CodeMiscellaneous
- K870901MT8 BIOLOGICAL TELEMETRY SYSTEMCleared 510(K)
- K865002A-BEC 18Cleared 510(K)
- K864501KOKEN'S NEW MODEL M-3000 POWER TABLECleared 510(K)
- K863838CREST CERVICAL TRACTIONCleared 510(K)
- K862893VENTRAL STANDING UNITCleared 510(K)
- K861343R1618, R1619 & R1654 ICE MAKING MACHINESCleared 510(K)
- K861399POWERSTIM ELECTRONIC MUSCLE STIMULATORCleared 510(K)
- K854194IMT ULTRASONIC STRIDE MONITORCleared 510(K)
- K860618THRUST-AIRE MODEL 2001Cleared 510(K)
- K853541SP 4Cleared 510(K)
- K852034VITATRON MCleared 510(K)
- K852152FLEXISTAND MAJORCleared 510(K)
- K850870MEDIFETTE ERGOMETERCleared 510(K)
- K850868MFE CARDIAC STRESS SYSTEMCleared 510(K)
- K850872PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STICleared 510(K)
- K850875ACTION-WHEELS & PLAY WHEELSCleared 510(K)
- K851690ADJUSTABLE TREATMENT TABLESCleared 510(K)
- K850388ITI 200 ELECTRIC MOTOR DRIVE, UNIV.-WHEELCHAIR ACCCleared 510(K)
- K850172ELEKIBAN MAGNETO-THERAPEUTIC DEVICECleared 510(K)
- K850087BIOLOGICAL TELEMETRY SYSTEMCleared 510(K)
- K844157HOLDSTER ARM RETENTION SYSTEMCleared 510(K)
- K843203CRYO MASSAGE CUPCleared 510(K)
- K840036FITEXCleared 510(K)
- K842791ORTHO ACTIVE WRIST BRACECleared 510(K)
- K842790ORTHO ACTIVE KNEE BRACECleared 510(K)
- K841994EZY-RAMPCleared 510(K)
- K841598MEDIUM FREQ. ELECTRICAL MUSCLE STIMULACleared 510(K)
- K841693STANDING FRAMECleared 510(K)
- K841692PRONE STANDERCleared 510(K)
- K840276DISPOSABLE, PRESSURE RELIEF VALVECleared 510(K)
- K840403VENA * BRIDGECleared 510(K)
- K840639POIRIER COMMODESCleared 510(K)
- K834137CHIROPRACTIC ACTIVATOR OR PORT. CHIROCleared 510(K)
- K834143NYLON COMPRESSION STUMP SHEATHCleared 510(K)
- K833324SPECIFIC ATLAS MICROJUSTCleared 510(K)
- K832881ADVANTAGE SERIES CONTOURED LUMBO SACARCleared 510(K)
- K832494SCOLIOMETERCleared 510(K)
- K832321ACCES. HEAD CONTROL-POWERED CHEELCHAIRCleared 510(K)
- K831474MINI PULSATORCleared 510(K)
- K831472ULTRA PULSATORCleared 510(K)
- K822770BURLINGTON STOCKINETTECleared 510(K)
- K830443LATERAL POSITIONING ATTACHMENTCleared 510(K)
- K830349SAC-RO-FORM INSERT & BINDERCleared 510(K)
- K823362ENDOMED 433Cleared 510(K)
- K823643INFLATABLE PILLOWCleared 510(K)
- K823631NON-SLIP VINYL BATH MATCleared 510(K)
- K823651SCISSORSCleared 510(K)
- K823655BOOK ON MGMT. OF THE BURN PATIENTCleared 510(K)
- K823653THINNING SOLUTION SALVENT BASED COAT-MATCleared 510(K)
- K823652PRIMARY SOLUTION SALVENT BASED COAT- METCleared 510(K)
- K823598LARGE TERRYCLOTH BIBCleared 510(K)
- K823793ABC BRANDCleared 510(K)
- K823629FORMED STEEL DEVICE KEEP LEGS SEPARATEDCleared 510(K)
- K823093CHANNEL BACKCleared 510(K)
- K821808MILBURN'S BACKEASERCleared 510(K)
- K820827P105Cleared 510(K)
- K821647FOAM WEDGESCleared 510(K)
- K820517CONSTRUCTA FOAMCleared 510(K)
- K812903HUTT SWIVEL WALKER & HUTT STANDING FRAMECleared 510(K)
- K812724RELAXATION TANKCleared 510(K)
- K813006MODEL TDS-2450-2 MICROWAVE DIATHERMY SYSCleared 510(K)
- K811114MODEL P-8 PROFESSIONALCleared 510(K)
- K813025STANDING FRAMECleared 510(K)
- K812052MYOCATH CATOLOG NO. MCK-ACleared 510(K)
- K812176KORICLEANCleared 510(K)
- K812481BACKRESTCleared 510(K)
- K811657P.D. CRADLECleared 510(K)
- K802977IPOCARBON STRETCH STOCKINETTECleared 510(K)
- K802976CARBONACRYLCleared 510(K)
- K802805NEMECTRODYN 5Cleared 510(K)
- K802008BREAKING CAST WIRE CAT.#1112-1115Cleared 510(K)
- K801900LIFE CERVICAL ADJUSTING MACHINECleared 510(K)
- K800132SHUTRAKCleared 510(K)
- K790861MOIRE CONTOURGRAPH, MODELS MS-1, SS-1Cleared 510(K)
- K780927TI-COMFORTERCleared 510(K)
- K780282BARRIER HIP PACK W/ FABRIC 450Cleared 510(K)
- K772143GENERATORCleared 510(K)
- K7712442,2DIMETHOXY-2-PHENYLACETOPHENONECleared 510(K)
- K760214STIMULATOR, PNEUMATICCleared 510(K)
- K770059ORTHOPEDIC SPECIALTIESCleared 510(K)
- K760896BARRIER ORTHOPAEDIC SPLIT SHEETCleared 510(K)
- K761075SPORTS RECORDER (SR-10)Cleared 510(K)
- K761227INTERMITTENT PRESSURE PADCleared 510(K)
- K760297CARRIER, FOLDING LUGGAGE, BK-6511Cleared 510(K)
- K760235SUTURE GUIDECleared 510(K)
- K760001ARCH SUPPORT (ARCH AID)Cleared 510(K)
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
MODEL P-8 PROFESSIONAL
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K811114
- 510(k) Type
- Traditional
- Applicant
- BLOOMEX INTERNATIONAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/23/1981
- Days to Decision
- 214 days