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
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- IMKWheelchair, Stair Climbing2Product Code
- IMLArmrest, Wheelchair1Product Code
- IMMFootrest, Wheelchair1Product Code
- IMNClimber, Curb, Wheelchair1Product Code
- IMOHandrim, Wheelchair1Product Code
- IMPCushion, Wheelchair1Product Code
- IMQAttachment, Narrowing, Wheelchair1Product Code
- IMRDevice, Anti-Tip, Wheelchair1Product Code
- QNXExternal Compression Device For Internal Jugular Vein Compression2Product Code
- ILESling, Arm, Overhead Supported1Product Code
- ILGStocking, Elastic1Product Code
- ILHSplint, Hand, And Components1Product Code
- ILISling, Arm1Product Code
- ILPSystem, Communication, Non-Powered1Product Code
- ILQSystem, Communication, Powered2Product Code
- IMSSupport, Head And Trunk, Wheelchair1Product Code
- IMWBrake, Extension, Wheelchair1Product Code
- IMXBoard, Lap, Wheelchair1Product Code
- IMYArmboard, Wheelchair1Product Code
- IMZHolder, Crutch And Cane, Wheelchair1Product Code
- INAHill Holder, Wheelchair1Product Code
- INBAttachment, Commode, Wheelchair1Product Code
- INCCuff, Pusher, Wheelchair1Product Code
- INESling, Overhead Suspension, Wheelchair1Product Code
- INFScale, Platform, Wheelchair1Product Code
- INGElevator, Wheelchair, Portable2Product Code
- INIVehicle, Motorized 3-Wheeled2Product Code
- INKStretcher, Wheeled, Powered2Product Code
- INMChair, With Casters1Product Code
- INNChair, Adjustable, Mechanical1Product Code
- INOChair, Positioning, Electric2Product Code
- INPTips And Pads, Cane, Crutch And Walker1Product Code
- INQTable, Powered1Product Code
- INTPlinth1Product Code
- INWTable, Mechanical1Product Code
- IORWheelchair, Mechanical1Product Code
- K251886EmpowerRide NAVIGATOR1Cleared 510(K)
- K252828Manual Wheelchair (W47)1Cleared 510(K)
- K252825Manual Wheelchair (W45)1Cleared 510(K)
- K252687Manual Wheelchair (HM305-Air1, HM305-Air2)1Cleared 510(K)
- K250576Flexx Junior (FLX-J00, FLX-J50)1Cleared 510(K)
- K252517Manual Wheelchair (SYIV100A008)1Cleared 510(K)
- K241374Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)1Cleared 510(K)
- K243111Bowhead ERA Wheelchairs1Cleared 510(K)
- K242722Manual Wheelchair (MASY23)1Cleared 510(K)
- K242560Manual Wheelchair (SYIV100-CA9221)1Cleared 510(K)
- K241460Manual Wheelchair1Cleared 510(K)
- K240120Merlexi Craft Bariatric series of manual wheelchairs1Cleared 510(K)
- K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)1Cleared 510(K)
- K232199Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE)1Cleared 510(K)
- K232198Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)1Cleared 510(K)
- K200583Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL1Cleared 510(K)
- K223527Little Wave Clik, Rogue XP, Little Wave XP, Spark1Cleared 510(K)
- K231750MA012 Aluminum wheelchair, MS019 steel wheelchair1Cleared 510(K)
- K231110Manual Wheelchair (A006)1Cleared 510(K)
- K231320Zhenjiang Assure Mechanical Wheelchair,model:K11Cleared 510(K)
- K220698Bambino 3, S3 and S3 Swing, U3 and U3 Light, X1Cleared 510(K)
- K221435SUPERTILT PLUS (STP)1Cleared 510(K)
- K220671Manual Wheelchair1Cleared 510(K)
- K200715RoughRider Aurora Manual Wheelchair1Cleared 510(K)
- K213790Aluminum back folding wheelchair SYIV 100-LQXAL2482-4071Cleared 510(K)
- K200466Manual Wheelchair (Model W28)1Cleared 510(K)
- K201461Manual Wheelchair, Model A0111Cleared 510(K)
- K200135RGK Daily Range Wheelchairs1Cleared 510(K)
- K192658Manual Wheelchair1Cleared 510(K)
- K190550IKON 40 Manual Wheelchair1Cleared 510(K)
- K190534Manual Wheelchair SIVFH2A1021Cleared 510(K)
- K190699Rowheels Revolution 1.01Cleared 510(K)
- K180309Manual Wheelchair W541Cleared 510(K)
- K182840Element Pediatric Wheelchair1Cleared 510(K)
- K180852Manual Wheelchair1Cleared 510(K)
- K181090Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs1Cleared 510(K)
- K181795AST Model MA012 and MS019 Rehab Wheelchair1Cleared 510(K)
- K173360Athena 1901Cleared 510(K)
- K170517Merits Model R106/R136 Rehab Wheelchair1Cleared 510(K)
- K171017Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T1Cleared 510(K)
- K163352Wheelchair1Cleared 510(K)
- K163432Stellar LEAP1Cleared 510(K)
- K162328Winner Transfer Wheelchair1Cleared 510(K)
- K162621Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair1Cleared 510(K)
- K170701GEN_2 and GEN_3 Mechanical Wheelchairs1Cleared 510(K)
- K162696Kuschall Advance Manual Wheelchair1Cleared 510(K)
- K162692Kuschall K-Series Attract Manual Wheelchair1Cleared 510(K)
- K162686Kuschall Champion Manual Wheelchair1Cleared 510(K)
- K161425APEX Manual Wheelchair1Cleared 510(K)
- K153328SUNCO Mechanical Wheelchair, model SKW-90031Cleared 510(K)
- K151492Kudu1Cleared 510(K)
- K152021Pure Tilt1Cleared 510(K)
- K152827Weely Manual Wheelchair1Cleared 510(K)
- K152878SUNTEC Mechanical Wheelchair, model ST-WL-10001Cleared 510(K)
- K152536MyOn HC Manual Wheelchair1Cleared 510(K)
- K151893P.R.O. CG Manual Wheelchair1Cleared 510(K)
- K151797Nuocande Plastic Manual Wheelchair Model NKD L071Cleared 510(K)
- K143101Helio A7 Manual Wheelchair, Move Manual Wheelchair1Cleared 510(K)
- K141691GEN_31Cleared 510(K)
- K140023ELEVATION1Cleared 510(K)
- K140416TREKKER, TREKKER TRANSIT1Cleared 510(K)
- K130017VALENTINE STEEL WHEELCHAIR1Cleared 510(K)
- K130517EZ TRANSPORT CHAIR1Cleared 510(K)
- K132257MANUAL WHEELCHAIR1Cleared 510(K)
- K133855BREEZY ELEGANCE1Cleared 510(K)
- K130788CAPELLA1Cleared 510(K)
- K130848SHANGHAI PHOENIX MECHANICAL WHEELCHAIR1Cleared 510(K)
- K131336TX WHEELCHAIR CHASSIS1Cleared 510(K)
- K131529SHENGGUANG MANUAL WHEELCHAIR1Cleared 510(K)
- K123975QUICKIE & ZIPPIE SERIES1Cleared 510(K)
- K123076PROFTHAND MECHANICAL WHEELCHAIR1Cleared 510(K)
- K113164DISCOVERY TMAX MANUAL WHEELCHAIR1Cleared 510(K)
- K120391MR4500 WHEELCHAIR1Cleared 510(K)
- K120628HELIO1Cleared 510(K)
- K120501CHAMP CHAMP TRANSIT1Cleared 510(K)
- K120077COMED K-SERIES MANUAL WHEELCHAIR1Cleared 510(K)
- K113713GEN_2 MECHANICAL WHEELCHAIR1Cleared 510(K)
- K112816ZHENJIANG ASURE MECHANICAL WHEELCHAIR1Cleared 510(K)
- K120032MECHANICAL WHEELCHAIR1Cleared 510(K)
- K111636REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM1Cleared 510(K)
- K112948JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR1Cleared 510(K)
- K112950JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR1Cleared 510(K)
- K120526YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR1Cleared 510(K)
- K111739KIDS ROCK 3 CHAIR1Cleared 510(K)
- K111045CENTRO FAMILY OF MANUAL WHEELCHAIRS1Cleared 510(K)
- K110788INNOVA WHEELCHAIR1Cleared 510(K)
- K110985ICON ADULT MANUAL1Cleared 510(K)
- K103212ROUGHRIDER1Cleared 510(K)
- K103073SUPER CHAIR FOR KIDS BY ORION1Cleared 510(K)
- K102910MODEL LUNA MANUAL WHEELCHAIR1Cleared 510(K)
- K102061TREVAIR CHAIR ADULT1Cleared 510(K)
- K10211024 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN1Cleared 510(K)
- K102031GALAXY LITE1Cleared 510(K)
- K101998KAIYANG ALUMINUM WHEELCHAIR1Cleared 510(K)
- K101999KAIYANG STEEL WHEELCHAIR1Cleared 510(K)
- K101719TACAMO MANUAL WHEELCHAIR1Cleared 510(K)
- K101217MAC-MOBILE AQUATIC CHAIR1Cleared 510(K)
- K101277ORION II (HEAVY DUTY 350 LBS AND 500 LBS)1Cleared 510(K)
- K100824MECHANICAL WHEELCHAIR, MODEL DS 202-S1Cleared 510(K)
- K100084MULTI FRAME WHEELCHAIR1Cleared 510(K)
- K09404718 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR1Cleared 510(K)
- K091482HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K41Cleared 510(K)
- K091478TREVAIR CHAIR1Cleared 510(K)
- K083847MARVEL PEDIATRIC WHEELCHAIR1Cleared 510(K)
- K083231PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT1Cleared 510(K)
- K083044HUBANG, MODEL HBL13/HBG12-S1Cleared 510(K)
- K082970MARVEL WHEELCHAIR, MODEL EDCAL011Cleared 510(K)
- K082314BRAVORACER PEDIATRIC MANUAL WHEELCHAIR1Cleared 510(K)
- K082784JUMAO MANUAL WHEELCHAIR1Cleared 510(K)
- K082246DIGNITY 1001Cleared 510(K)
- K082274HAIDA MODEL HD11 MANUAL WHEELCHAIR1Cleared 510(K)
- K081665MILLENIUM II1Cleared 510(K)
- K080506MARTIN CHAIR, MODEL C4S11Cleared 510(K)
- K080270MANUAL RIGID MOBILITY WHEELCHAIR1Cleared 510(K)
- K080880RTM AND OVAL1Cleared 510(K)
- K080207DANYANG HUAYI K2 AND K7 WHEELCHAIRS1Cleared 510(K)
- K080114HUAYI H035 BASIC WHEELCHAIR1Cleared 510(K)
- K073512START JUNIOR1Cleared 510(K)
- K072311TILITE AERO X1Cleared 510(K)
- K072153QUICKIE QX MANUAL FOLDING WHEELCHAIR1Cleared 510(K)
- K071444MECHANICAL WHEELCHAIR - L-FRAME SERIES1Cleared 510(K)
- K070176MAXHEALTH MECHANICAL WHEELCHAIR, K11Cleared 510(K)
- K063736FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T501Cleared 510(K)
- K062660CATALYSY1Cleared 510(K)
- K062309KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 1051Cleared 510(K)
- K062311KARMA MANUAL WHEELCHAIR, MODEL BUDGET 8001Cleared 510(K)
- K062218JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP1Cleared 510(K)
- K061810COUGAR WHEELCHAIR1Cleared 510(K)
- K061694MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S1Cleared 510(K)
- K061475ASTROTILT MANUAL WHEELCHAIR1Cleared 510(K)
- K0612737000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L1Cleared 510(K)
- K061010FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR1Cleared 510(K)
- K060926TRIPOD1Cleared 510(K)
- K061186FLIGHT1Cleared 510(K)
- K060582INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR1Cleared 510(K)
- K060251WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL1001Cleared 510(K)
- K053574MEDLINE PEDIATRIC WHEELCHAIRS1Cleared 510(K)
- K052548UROK ROCKING WHEELCHAIR, MODEL 700-4XX1Cleared 510(K)
- K052586A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P1Cleared 510(K)
- K052681START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)1Cleared 510(K)
- K052468YK9000 SERIES MANUAL WHEELCHAIR1Cleared 510(K)
- K052521NISSIN SERIES MECHANICAL WHEELCHAIR1Cleared 510(K)
- K051369SYRYKER SORANO WHEELCHAIR1Cleared 510(K)
- K051302EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR1Cleared 510(K)
- K051482JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP1Cleared 510(K)
- K051481JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP1Cleared 510(K)
- K051090X-CHANGE1Cleared 510(K)
- K050941BRIX WHEELCHAIR1Cleared 510(K)
- K050708LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-90001Cleared 510(K)
- K050691R. POON MEDICAL PRODUCTS WHEELCHAIRS1Cleared 510(K)
- K050560EUROCHAIR1Cleared 510(K)
- K050707LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-30001Cleared 510(K)
- K050279AXS-1 LITE WHEELCHAIR1Cleared 510(K)
- K050280RUNABOUT WHEELCHAIR1Cleared 510(K)
- K050281TRANSPORT SERIES TRANSPORT CHAIR1Cleared 510(K)
- K050345CIE FOLDAWAY WHEELCHAIR1Cleared 510(K)
- K050290LERADO, COSCO1Cleared 510(K)
- K043332WHEELCHAIR, MODEL 8500-II1Cleared 510(K)
- K042652TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR1Cleared 510(K)
- K042444LITESTREAM 500E1Cleared 510(K)
- K042401VARI-ABLE APB (ADAPTABLE POSITIONING BASE)1Cleared 510(K)
- K042304CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 2511Cleared 510(K)
- K041465SINON SN-L402 LIGHTWEIGHT WHEELCHAIR1Cleared 510(K)
- K041814FS SERIES WHEELCHAIR1Cleared 510(K)
- K041337PRO WALKER ML-300 FOLDABLE WHEELCHAIR1Cleared 510(K)
- K040677COMBI SELF PROPELLED SHOWER COMMODE1Cleared 510(K)
- K041072KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT1Cleared 510(K)
- K040622FREEDOM HP1Cleared 510(K)
- K040561MANUAL WHEELCHAIR SERIES1Cleared 510(K)
- K033460CHEETAH WHEELCHAIR1Cleared 510(K)
- K033031TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR1Cleared 510(K)
- K033141MECHANICAL WHEEHCHAIR1Cleared 510(K)
- K033125HANDIVIPP1Cleared 510(K)
- K032731MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS1Cleared 510(K)
- K032402RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,1Cleared 510(K)
- K032123SHOCKWAVE SUSPENSION WHEELCHAIR1Cleared 510(K)
- K031910STAINLESS STEEL AQUATIC WHEELCHAIR1Cleared 510(K)
- K032133BRODA MODEL 587 MANUAL WHEELCHAIR1Cleared 510(K)
- K030017CHUMP1Cleared 510(K)
- K023993GALAXY SERIES WHEELCHAIR1Cleared 510(K)
- K024055TILITE EVO1Cleared 510(K)
- K024030MILLENNIUM SERIES MANUAL WHEELCHAIRS1Cleared 510(K)
- K023574GIZMO1Cleared 510(K)
- K023606TILITE YG AND TILITE YGS1Cleared 510(K)
- K023005AQUILLA MODULAR WHEELCHAIR1Cleared 510(K)
- K022924SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)1Cleared 510(K)
- K022825MANUAL WHEELCHAIR1Cleared 510(K)
- K022700DELUXE MANUAL WHEELCHAIR HW 40001Cleared 510(K)
- K022699TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR1Cleared 510(K)
- K022617COMFY HIGH RISER WHEELCHAIR1Cleared 510(K)
- K021075MECHANICAL DAILY USE WHEELCHAIR1Cleared 510(K)
- K021866KARMA 800 SERIES MANUAL WHEELCHAIR1Cleared 510(K)
- K021145ACCOMMODATOR WHEELCHAIR, MODEL #2000X1Cleared 510(K)
- K020737CAT ACTIVE WHEELCHAIR1Cleared 510(K)
- K020536GAZELLE WHEELCHAIR1Cleared 510(K)
- K020451COMFORT WHEELCHAIRS1Cleared 510(K)
- K020472BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR1Cleared 510(K)
- K020188BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR1Cleared 510(K)
- K020094EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS1Cleared 510(K)
- K020100SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS1Cleared 510(K)
- K020284BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR1Cleared 510(K)
- K014198BIOTECH B990K VIVI WHEELCHAIR1Cleared 510(K)
- K013761MEDLINE EXCEL RECLINCER WHEELCHAIR1Cleared 510(K)
- K012370SOLARA JR. MANUAL WHEELCHAIR1Cleared 510(K)
- K012167MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR1Cleared 510(K)
- K011752GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY1Cleared 510(K)
- K011701BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR1Cleared 510(K)
- K011374JEWEL MPS1Cleared 510(K)
- K011268BREEZY WHEELCHAIR, MODEL 3001Cleared 510(K)
- K010823SPAZZ1Cleared 510(K)
- K010194COMFOR-CLINER1Cleared 510(K)
- K010094A & I WHEELCHAIRS1Cleared 510(K)
- K003862MADA WHEELCHAIRS1Cleared 510(K)
- K003783MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER1Cleared 510(K)
- K003048ALL TERRAIN WHEELCHAIR (ATW)1Cleared 510(K)
- K002943WHEELCHAIR, MECHANICAL SERIES MODEL 31001Cleared 510(K)
- K002876JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM1Cleared 510(K)
- K002670EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR1Cleared 510(K)
- K002669EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR1Cleared 510(K)
- K002673EZ-COMFORT TRANSPORTER 2000 SERIES1Cleared 510(K)
- K002671EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR1Cleared 510(K)
- K002317MODEL 9000 BARIATRIC WHEELCHAIR1Cleared 510(K)
- K002202KARMAN WHEELCHAIR1Cleared 510(K)
- K002167KARMAN WHEELCHAIR1Cleared 510(K)
- K001909PLAINSENSE WHEELCHAIR1Cleared 510(K)
- K002205CARONY1Cleared 510(K)
- K002170MODEL 9000 PEDIATRIC WHEELCHAIR1Cleared 510(K)
- K001890SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR)1Cleared 510(K)
- K001391BONUS MECHANICAL WHEELCHAIR1Cleared 510(K)
- K001298J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR1Cleared 510(K)
- K001252MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-86511Cleared 510(K)
- K000738WHEELCHAIR, MODELS H001A, 44221Cleared 510(K)
- K000497VOYAGER/VIPER WHEELCHAIR1Cleared 510(K)
- K000602PROTEGE WHEELCHAIR1Cleared 510(K)
- K000174ACTION AF-1 WHEELCHAIR1Cleared 510(K)
- K994185MANUAL WHEELCHAIR1Cleared 510(K)
- K993963SIGMA MANUAL WHEELCHAIR1Cleared 510(K)
- K993640SPECTRUM LIBRE WHEELCHAIR1Cleared 510(K)
- K993298E Z CHAIR1Cleared 510(K)
- K992884WHEELCHAIR (MANUAL, NOT ELECTRICAL)1Cleared 510(K)
- K992310TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.1Cleared 510(K)
- K992035MANUAL WHEELCHAIR1Cleared 510(K)
- K990139KENSTONE1Cleared 510(K)
- K990555TISPORT X AND TISPORT XC1Cleared 510(K)
- K990557THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR1Cleared 510(K)
- K990463MEDLINE EXCEL WHEELCHAIRS1Cleared 510(K)
- K990358CROSS SPORT, RIGID WHEELCHAIR1Cleared 510(K)
- K990157MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR1Cleared 510(K)
- K984367ACTIVX1Cleared 510(K)
- K984354MECHANICAL WHEELCHAIR1Cleared 510(K)
- K984457WORLD CLASS WHEELED CHAIR, MODEL SS1Cleared 510(K)
- K984493MAXXIM; MAXXIM HD1Cleared 510(K)
- K984447MODEL ACTION AT II MANUAL WHEELCHAIR1Cleared 510(K)
- K983681DOMINATOR1Cleared 510(K)
- K983859SPECTRUM SMALL FRY1Cleared 510(K)
- K983763SPECTRUM SPIRIT1Cleared 510(K)
- K983639ZIPPIE GS, MODEL # EIZGS1Cleared 510(K)
- K982989QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR1Cleared 510(K)
- K982849PANTHER WHEELCHAIR1Cleared 510(K)
- K982099MOMENTUM NO. FS008 WHEELCHAIR1Cleared 510(K)
- K982607MANUAL WHEELCHAIR1Cleared 510(K)
- K982336KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS1Cleared 510(K)
- K981557MYCYCLE, HANDMASTER, VICTORY1Cleared 510(K)
- K981558MYCYCLE HANDMASTER, LIGHT1Cleared 510(K)
- K981419TC SERIES (TILT RECLINER)1Cleared 510(K)
- K981418TC SERIES (TRANSPORT)1Cleared 510(K)
- K981420TC SERIES (WIDE)1Cleared 510(K)
- K981421TC SERIES (RECLINER)1Cleared 510(K)
- K981422TC SERIES1Cleared 510(K)
- K980107RUNCH INDUSTRIAL WHEELCHAIR1Cleared 510(K)
- K974820BREEZY SERIES1Cleared 510(K)
- K974197ELITE LIGHTWEIGHT WHEELCHAIR1Cleared 510(K)
- K973491MECHANICAL FOLDING WHEEL CHAIR1Cleared 510(K)
- K973673QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES1Cleared 510(K)
- K973418UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)1Cleared 510(K)
- K973473ASLI1Cleared 510(K)
- K972797TOOL-LESS WHEEL CHAIR1Cleared 510(K)
- K971389ECLIPSE 400 MANUALLY OPERATED WHEELCAIR1Cleared 510(K)
- K971142ADVENTURER1Cleared 510(K)
- K964932ELEVATING AND REMOVABLE LEG AND REMOVABLE ARM WHEELCHAIR1Cleared 510(K)
- K970311BENTLEY MANUALLY OPERATED WHEELCHAIR1Cleared 510(K)
- K964682SKYWAY1Cleared 510(K)
- K963301STANDARD WHEELCHAIR1Cleared 510(K)
- K961743ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR1Cleared 510(K)
- K961514BCW ADVANTAGE WHEELCHAIR1Cleared 510(K)
- K960402BUDDY WHEELCHAIR1Cleared 510(K)
- K954376MUSTANG1Cleared 510(K)
- K955295SPLASH & GO II1Cleared 510(K)
- K954370WHEEL LEMASTER1Cleared 510(K)
- K954328CLEAN ROOM WHEELCHAIR1Cleared 510(K)
- K954568THE REIFF QUANTUM WHEELCHAIR, OR QUANTUM WHEELCHAIRS1Cleared 510(K)
- K954344RUSSON INDUSTRIES FURNITURE QUALITY WHEELCHAIR1Cleared 510(K)
- K954261LANDEEZ ALL-TERRAIN WHEELCHAIR1Cleared 510(K)
- K953427CHAMPION, 3000 REBEL1Cleared 510(K)
- K953426COMPETITOR1Cleared 510(K)
- K953428CHAMPION, 30001Cleared 510(K)
- K953429CHAMPION, 10001Cleared 510(K)
- K952641QUICKIE TSR1Cleared 510(K)
- K952431SPECTRUM1Cleared 510(K)
- K952069MECHANICAL WHEELCHAIR1Cleared 510(K)
- K951621J & S WHEELCHAIRS MODELS 500, 500B, 502, 503, 504 AND 500T1Cleared 510(K)
- K951847AVANTGARDE1Cleared 510(K)
- K950815CHAMPION1Cleared 510(K)
- K945175MECHANICAL WHEELCHAIR 890.38501Cleared 510(K)
- K945153MECHANICAL WHEELCHAIR- LIL DIPPER1Cleared 510(K)
- K945148MECHANICAL WHEELCHAIR- AVENGER1Cleared 510(K)
- K945149MECHANICAL WHEELCHAIR- CHALLENGER1Cleared 510(K)
- K945150MECHANICAL WHEERCHAIR- ECLIPSE1Cleared 510(K)
- K945151MECHANICAL WHEELCHAIR- G-FORCE1Cleared 510(K)
- K945152MECHANICAL WHEELCHAIR- IMPACT1Cleared 510(K)
- K951351X2000 TRADITIONAL WHEELCHAIR1Cleared 510(K)
- K951560RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)1Cleared 510(K)
- K951120SUN-BURST1Cleared 510(K)
- K950904ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)1Cleared 510(K)
- K950903ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR)1Cleared 510(K)
- K951138MODELS PHOENIX AND CONCEPT 45 MANUAL MECHANICAL WHEELCHAIRS1Cleared 510(K)
- K951037AKISU FOLDING WHEELCHAIR, MODELS AW-900, 910, 920, 930, 950 AND AW-820, 8301Cleared 510(K)
- K950195KARMA WHEELCHAIR1Cleared 510(K)
- K946195SUMMIT MECHANICAL WHEELCHAIR1Cleared 510(K)
- K946079CAD ON WHEELS1Cleared 510(K)
- K945534MECHANICAL WHEELCHAIR - BOING1Cleared 510(K)
- K945533MECHANICAL WHEELCHAIR - SUPERNOVA1Cleared 510(K)
- K944970SOLUTION1Cleared 510(K)
- K944574LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI)1Cleared 510(K)
- K943936XLT, REA COMFORT, SPIREA, ZOOM1Cleared 510(K)
- K944122DAB WELDLESS WHEELCHAIR1Cleared 510(K)
- K943293SCC22/ SCC26 SHOWER COMMODE CHAIR1Cleared 510(K)
- K941976WHEELCHAIR,MECHANICAL1Cleared 510(K)
- K941989ACTION AT MANUAL WHEELCHAIR1Cleared 510(K)
- K941301ROLL A BOUT WALKER1Cleared 510(K)
- K941088STRYKER BACK-SAVER STRETCHER CHAIR MODEL 63201Cleared 510(K)
- K941157BASIC RECLINE CHAIR1Cleared 510(K)
- K941236VECTOR WHEELCHAIR1Cleared 510(K)
- K930803ACTION PATRIOT MANUAL WHEELCHAIR1Cleared 510(K)
- K934236LEGEND (MANUAL WHEELCHAIR)1Cleared 510(K)
- K934234VISION (MANUAL WHEELCHAIR)1Cleared 510(K)
- K935398TRACER SERIES MANUAL WHEELCHAIRS1Cleared 510(K)
- K940304NITRO1Cleared 510(K)
- K940303RECORD1Cleared 510(K)
- K935211WALK N CHAIR1Cleared 510(K)
- K934560WIZARD PEDIATRIC WHEELCHAIR1Cleared 510(K)
- K934418BASIC TILT CHAIR ( BTC )1Cleared 510(K)
- K934646ACTION WIZARD PEDIATRIC MANUAL WHEELCHAIR1Cleared 510(K)
- K934297DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR1Cleared 510(K)
- K934263PORTABLE STANDARD1Cleared 510(K)
- K933919MICROLITE WHEELCHAIR1Cleared 510(K)
- K933406TRAVEL EASE1Cleared 510(K)
- K932927SRX COMP ULTRALIGHT WHEELCHAIR1Cleared 510(K)
- K932795HAVERICH ORTHOPAEDIC CYCLES1Cleared 510(K)
- K932639MANUAL TILT RECLINE CHAIR (MTC)1Cleared 510(K)
- K931751ZERO GRAVITY WHEELCHAIR1Cleared 510(K)
- K930413PREMIER CLASSIC1Cleared 510(K)
- K930412PREMIER 2 WHEELCHAIR1Cleared 510(K)
- K930411UNIVERSAL WHEELCHAIR1Cleared 510(K)
- K925451SHADOW RIGID WHEELCHAIR1Cleared 510(K)
- K921028MANUAL RECLINING CHAIR1Cleared 510(K)
- K923428PANDA1Cleared 510(K)
- K925272PEDIATRIC TILT CHAIR1Cleared 510(K)
- K925146FOLDING, WHEELCHAIR1Cleared 510(K)
- K923291NAICO WHEEL CHAIRS1Cleared 510(K)
- K922535THE TERMINATOR1Cleared 510(K)
- K921847ACTION FX MANUAL WHEELCHAIR1Cleared 510(K)
- K920179ZIPPIE P5001Cleared 510(K)
- K921136MANUAL TILT CHAIR1Cleared 510(K)
- K920391VOYAGEUR AND LAURENTIAN SERIES WHEELCHAIR1Cleared 510(K)
- K915533QUICKIE CARBON WHEELCHAIR1Cleared 510(K)
- K915262BANTEX BRAND WHEELCHAIRS1Cleared 510(K)
- K915108FOLDING WHEELCHAIR1Cleared 510(K)
- K914610SWEDE CROSS MANUAL WHEELCHAIR1Cleared 510(K)
- K914785WHEELCHARIOT LIGHTWEIGHT MANUAL WHEELCHAIR1Cleared 510(K)
- K914553ACTION SERIES MANUAL WHEELCHAIRS, VARIOUS MODELS1Cleared 510(K)
- K913759DUET BICYCLE/WHEELCHAIR1Cleared 510(K)
- K913512IMPALA1Cleared 510(K)
- K911119SOPUR GMBH WHEELCHAIRS1Cleared 510(K)
- K910747FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR1Cleared 510(K)
- K905256NEXT WAVE(R) PHYSIOACCOUSTIC(TM) CHAIR1Cleared 510(K)
- K910746FORTRESS FREESTYLE II MANUAL FOLDING WHEELCHAIR1Cleared 510(K)
- K910752FORTRESS LIBERTY MANUAL FOLDING WHEELCHAIR1Cleared 510(K)
- K910750FORTRESS CUSTOM MANUAL FOLDING WHEELCHAIR1Cleared 510(K)
- K910748FORTRESS EDGE MANUAL RIGID WHEELCHAIR1Cleared 510(K)
- K905671BRODA WHEELCHAIR1Cleared 510(K)
- K905621ELLIPSE 2.31Cleared 510(K)
- K904152S.P.F. PREMIER 2 WHEELCHAIR1Cleared 510(K)
- K903981WHEELCHAIRS, TRANSIT/FOLDING/GLIDEABOUT/ACCESS1Cleared 510(K)
- K902439RX ROCKER TRIUMPH WHEELCHAIR1Cleared 510(K)
- K902438RX ROCKER WHEELCHAIR1Cleared 510(K)
- K902440RX ROCKER TRIUMPH, JR. WHEELCHAIR1Cleared 510(K)
- K900938MANUAL WHEELCHAIR1Cleared 510(K)
- K900191MCT COMPOSITE CHAIR1Cleared 510(K)
- K894422TUFFCARE MEDICAL PRODUCTS WHEELCHAIR1Cleared 510(K)
- K894345ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR1Cleared 510(K)
- K894136WORLD CHAIR1Cleared 510(K)
- K890050ZIPPIE & QUICKIE 2HP WHEELCHAIR1Cleared 510(K)
- K885330WHEELCHAIR, MECHANICAL1Cleared 510(K)
- K884932INVACARE YOUTHMOBILE 5000 SERIES WHEELCHAIR1Cleared 510(K)
- K884931ROLLS 3000 SERIES WHEELCHAIR (YOUTHMOBILE)1Cleared 510(K)
- K883275SWEDE ELITE, MECHANICAL WHEELCHAIR1Cleared 510(K)
- K883034WHEELCHAIR BCW 60001Cleared 510(K)
- K881951RIDE-LITE 9000 SERIES WHEELCHAIR1Cleared 510(K)
- K881762ROLLS 2000 SERIES WHEELCHAIR1Cleared 510(K)
- K881452FOLDING WHEELCHAIR1Cleared 510(K)
- K881410THE ADVENTURER1Cleared 510(K)
- K881051SAFETY PLUS MODEL 5011Cleared 510(K)
- K880280BREEZY WHEELCHAIR1Cleared 510(K)
- K875034SWEDE CHAMP (WHEELCHAIR)1Cleared 510(K)
- K875035SWEDE PETITE (WHEELCHAIR)1Cleared 510(K)
- K874246IRON HORSE ONE1Cleared 510(K)
- K874317POIRIER KID-ROLLER MANUAL WHEELCHAIR1Cleared 510(K)
- K872940FOLDING WHEELCHAIR1Cleared 510(K)
- K870425AUTO ENTRY SYSTEM (MATE)1Cleared 510(K)
- K870476QUICKIE RX PRESCRIPTION WHEELCHAIR1Cleared 510(K)
- K870295SIOUX MODEL 102ALW WHEELCHAIR1Cleared 510(K)
- K870294CROW MODEL 106A WHEELCHAIR1Cleared 510(K)
- K870293NAVAJO MODEL 103A WHEELCHAIR1Cleared 510(K)
- K870292CHEYENNE MODEL 107A WHEELCHAIR1Cleared 510(K)
- K870291CHEROKEE MODEL 102A WHEELCHAIR1Cleared 510(K)
- K870296MOHAVE MODEL 102W WHEELCHAIR1Cleared 510(K)
- K870043GUO GUANG WHEEL CHAIR1Cleared 510(K)
- K8649012000LT WHEELCHAIR1Cleared 510(K)
- K864790POIRIER MANUAL WHEELCHAIR1Cleared 510(K)
- K864684ACTIVE LIGHTWEIGHT WHEELCHAIR1Cleared 510(K)
- K864573ALT WHEELCHAIR1Cleared 510(K)
- K863892THERACARE LOUNGER1Cleared 510(K)
- K862892CASTER CAR1Cleared 510(K)
- K862889KIRO, WHEELCHAIR FOR CHILDREN1Cleared 510(K)
- K862890TOILET/SHOWER CHAIR1Cleared 510(K)
- K860521STANDARD WHEELCHAIRS1Cleared 510(K)
- K860072JUERGENS SELF RELIANT WHEELCHAIR1Cleared 510(K)
- K854497VOYAGEUR, BUTTERFLY ONE, CADET LAURENTIAN, HORIZON1Cleared 510(K)
- K853424THE MOVER1Cleared 510(K)
- K852109PENOX PERFORMER WHEELCHAIR1Cleared 510(K)
- K851553MERIUAARA & ERACARE WHEELCHAIRS1Cleared 510(K)
- K851227THE ENDURO1Cleared 510(K)
- K851257CRS ULTRALITE PREMIER1Cleared 510(K)
- K850536QUICKIE WHEELCHAIRS1Cleared 510(K)
- K850178DALTON FOLDING WHEELCHAIRS1Cleared 510(K)
- K850064WHEELCHAIR, MECHANICAL1Cleared 510(K)
- K844799ARTISAN FOLDING WHEELCHAIRS1Cleared 510(K)
- K844574WHEELCHAIRS1Cleared 510(K)
- K843688KARECO INT'L WHEELCHAIR1Cleared 510(K)
- K842232PLAIN JANE SERIES WHEELCHAIR1Cleared 510(K)
- K841830ULTRA-LITE PREMIER1Cleared 510(K)
- K840637HOSPITALIER WHEELCHAIR1Cleared 510(K)
- K840633AIRPORT WHEELCHAIR1Cleared 510(K)
- K840478EMCO WHEELCHAIR1Cleared 510(K)
- K840024WHEELCHAIR MECHANICAL1Cleared 510(K)
- K832685WHEELCHAIR-VARIOUS MODELS1Cleared 510(K)
- K832161AMBULIZER MODEL MC-51Cleared 510(K)
- K823849FREEDOM1Cleared 510(K)
- K801557ROLLS ROLLITE WHEELCHAIR1Cleared 510(K)
- K790183PORTABLE WHEELCHAIR & CARRYING CASE1Cleared 510(K)
- K780183WHEELCHAIRS, MECHANICAL1Cleared 510(K)
- IOYSupport, Arm1Product Code
- IOZSplint, Abduction, Congenital Hip Dislocation1Product Code
- IPGShoe, Cast1Product Code
- IPLWheelchair, Standup2Product Code
- IPMCover, Limb1Product Code
- IPOOrthosis, Pneumatic Structure, Rigid3Product Code
- IPRCrutch1Product Code
- IPSCane1Product Code
- IPTOrthosis, Thoracic1Product Code
- IPWOrthosis, Sacroiliac, Soft1Product Code
- IPXOrthosis, Rib Fracture, Soft1Product Code
- IPYOrthosis, Lumbo-Sacral1Product Code
- IQASystem, Environmental Control, Powered2Product Code
- IQBBelt, Wheelchair1Product Code
- IQCWheelchair, Special Grade2Product Code
- IQEOrthosis, Lumbar1Product Code
- IQFOrthosis, Cervical-Thoracic, Rigid1Product Code
- IQIOrthosis, Limb Brace1Product Code
- IQJSplint, Clavicle1Product Code
- IQKOrthosis, Cervical1Product Code
- IQMSplint, Temporary Training1Product Code
- IQODevice, Prosthesis Alignment1Product Code
- IQPRotator, Transverse1Product Code
- IQQJoint, Shoulder, External Limb Component1Product Code
- IQWHook, External Limb Component, Powered1Product Code
- IQXHook, External Limb Component, Mechanical1Product Code
- IQZHand, External Limb Component, Powered1Product Code
- IRAHand, External Limb Component, Mechanical1Product Code
- IRDJoint, Elbow, External Limb Component, Mechanical1Product Code
- IREJoint, Elbow, External Limb Component, Powered1Product Code
- ISHComponent, External, Limb, Ankle/Foot1Product Code
- ISLJoint, Hip, External Limb Component1Product Code
- ISMPylon, Post Surgical1Product Code
- ISNCable1Product Code
- ISPValve, Prosthesis1Product Code
- ISRBand Or Belt, Pelvic Support1Product Code
- ISSProsthesis, Thigh Socket, External Component1Product Code
- ISWAssembly, Knee/Shank/Ankle/Foot, External2Product Code
- ISYJoint, Knee, External Limb Component1Product Code
- ISZUnit, Wrist, External Limb Component, Mechanical1Product Code
- ITCStirrup, External Brace Component1Product Code
- ITGBandage, Cast1Product Code
- ITIWheelchair, Powered2Product Code
- ITJWalker, Mechanical1Product Code
- ITMCage, Knee1Product Code
- ITNSplint, Denis Brown1Product Code
- ITOTwister, Brace Setting1Product Code
- ITQJoint, Knee, External Brace1Product Code
- ITSJoint, Hip, External Brace1Product Code
- ITWJoint, Ankle, External Brace1Product Code
- KFTAssembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical1Product Code
- KFWAssembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered1Product Code
- KFXAssembly, Thigh/Knee/Shank/Ankle/Foot, External2Product Code
- KGHUnit, Wrist, External Limb Component, Powered1Product Code
- KHYCane, Safety Walk1Product Code
- KICCushion, Flotation1Product Code
- KIDRestraint, Wheelchair, Non-Protective1Product Code
- KNNComponents, Wheelchair1Product Code
- KNOAccessories, Wheelchair1Product Code
- KNPOrthosis, Corrective Shoe1Product Code
- KTDOrthosis, Abdominal1Product Code
- LBEStroller, Adaptive1Product Code
- LFFUnit, Activation, Breath Control1Product Code
- MNEOrthosis, Moldable, Supportive, Skin Protective1Product Code
- MRIOrthosis, Truncal/Orthosis, Limb1Product Code
- NDAHelmet, Cranial, For Protective Use1Product Code
- NHFMonitor, Orthotic/Prosthetic1Product Code
- NJBOrthosis, Truncal, For Dysmenorrhea1Product Code
- NXEWalker, Mechanical, Poly Vinyl Chloride (Pvc)1Product Code
- OHIOrthosis, Foot Drop1Product Code
- PAEUpper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography2Product Code
- PCEPermanently Mounted Wheelchair Platform Lift2Product Code
- PMVOrthosis, Limb, For Back Pain1Product Code
- QDTShoe With Adjustable Sole Units1Product Code
- 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
SPLASH & GO II
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K955295
- 510(k) Type
- Traditional
- Applicant
- KID'S WHEEL-CHAIRS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/30/1995
- Days to Decision
- 14 days
- Submission Type
- Statement