Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 40
- Latest Decision
- 1989-02-28
Clearances · page 40 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K890653 | ULTIMA WHEELCHAIR CUSHION | Clark Pillow Co., Inc. | IMP | Class I | 1989-02-28 |
| K890607 | SUTTER HOSPITAL CPM | Sutter Corp. | BXB | Class I | 1989-02-27 |
| K890490 | RUG BUG WHEEL CHAIR | Sinties Scientific, Inc. | ITI | Class II | 1989-02-27 |
| K890643 | VITALON CHAIR MASSAGER MODEL V-CHR2 | Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. | ISA | Class I | 1989-02-22 |
| K884834 | XOMED IONESTHETIZER(TM) | Xomed, Inc. | EGJ | Class II | 1989-02-15 |
| K890555 | PATIENT MOVER(TM) | T.B.S., Inc. | ILK | Class II | 1989-02-13 |
| K890548 | AQUACISER SYSTEM | Aquaciser, Inc. | ILJ | Class II | 1989-02-13 |
| K890554 | CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS | Consolidated Products & Services, Inc. | IMD | Class I | 1989-02-13 |
| K890553 | CP&S DISPOSABLE INSTANT COLD COMPRESS | Consolidated Products & Services, Inc. | IMD | Class I | 1989-02-13 |
| K890085 | SIT-N-BATHE SITZ BATH | Drummond Industries, Inc. | KTC | Class I | 1989-02-13 |
| K890523 | SUPERCAIR | Ssi Medical Services, Inc. | INX | Class II | 1989-02-10 |
| K890050 | ZIPPIE & QUICKIE 2HP WHEELCHAIR | Motion Designs, Inc. | IOR | Class I | 1989-02-08 |
| K885095 | SUPREME TONING SYSTEMS | Supreme Toning Systems | BXB | Class I | 1989-02-06 |
| K890200 | PNEUMATIC DORSIFLEXOR | Medical Flotation Systems, Inc. | BXB | Class I | 1989-02-03 |
| K890074 | SPINETRAK | Motion Analysis Corp. | LXJ | Class II | 1989-02-03 |
| K890076 | ORTHOTRAK | Motion Analysis Corp. | LXJ | Class II | 1989-02-03 |
| K890075 | FOOTTRAK | Motion Analysis Corp. | LXJ | Class II | 1989-02-03 |
| K885330 | WHEELCHAIR, MECHANICAL | Kaye Products, Inc. | IOR | Class I | 1989-02-03 |
| K890308 | HYDROTONE I | Hydrotonics Therapy Corp. | ILJ | Class II | 1989-01-31 |
| K884787 | ACCULITE-PPL 5 | Medical Alignment Systems | INE | Class I | 1989-01-24 |
| K884340 | AMX-110, AMX-II AND AMX-III | Dyna-Med | ILZ | Class I | 1989-01-24 |
| K881314 | PROMO-RIST C.P.M. | Professional Motion, Inc. | BXB | Class I | 1989-01-13 |
| K885062 | MODIFIED Q-SERIES OF TREADMILLS | Quinton, Inc. | IOL | Class I | 1988-12-27 |
| K885106 | REMOVABLE BATTERY POWER SYSTEM | Rolcontrol Products, Co., Inc. | KNN | Class I | 1988-12-27 |
| K884812 | KARMA-RS, KARMA-FS WHEELCHAIRS | Orthofab, Inc. | ITI | Class II | 1988-12-27 |
| K885105 | SLIDING ARM SUPPORT | Rolcontrol Products, Co., Inc. | KNN | Class I | 1988-12-27 |
| K884907 | BUMPY MEDICAL MASSAGE MAT | Medical Flotation Systems, Inc. | LYG | Class I | 1988-12-27 |
| K885103 | 1600 LIGHT TOUCH CONTROL | Rolcontrol Products, Co., Inc. | ITI | Class II | 1988-12-27 |
| K884908 | ULTRAFLOTATION MEDICAL WHEELCHAIR | Medical Flotation Systems, Inc. | INF | Class I | 1988-12-27 |
| K885104 | LAYDOWN ARM SUPPORT MECHANISM | Rolcontrol Products, Co., Inc. | KNN | Class I | 1988-12-27 |
| K882554 | MEDITRODE KIT | Life-Tech Intl., Inc. | EGJ | Class II | 1988-12-23 |
| K882731 | TAB PAK | Dynex Trading Co. | NXB | Class I | 1988-12-14 |
| K884931 | ROLLS 3000 SERIES WHEELCHAIR (YOUTHMOBILE) | Invacare Corp. | IOR | Class I | 1988-12-12 |
| K884932 | INVACARE YOUTHMOBILE 5000 SERIES WHEELCHAIR | Invacare Corp. | IOR | Class I | 1988-12-12 |
| K884835 | TASSI MK2 | Therapy Air Support Systems, Inc. | INX | Class II | 1988-12-07 |
| K882177 | ADD-ON TO CRITICAL PATIENT CARE BED | Cardio Systems, Inc. | IOQ | Class II | 1988-12-01 |
| K882413 | SUBOCCIPITAL ICE PILLOW | Ferguson Medical | IME | Class I | 1988-11-30 |
| K882406 | CONVA-LIFT | Numerical Concepts, Inc. | BXB | Class I | 1988-11-30 |
| K884760 | SHOWER CHAIR | Linido, Inc. | INM | Class I | 1988-11-30 |
| K884541 | PRO-VERTIC 2000 STAND-UP/SELF-RISING WHEELCHAIR | Pro-Vertic, Inc. | IPL | Class II | 1988-11-23 |
| K884529 | MICROAIR FLUIDIZED AIR BED | Gsi Development Co. | INX | Class II | 1988-11-18 |
| K884487 | LIDO TM ACTIVE BACK | Loredan Biomedical, Inc. | IKK | Class II | 1988-11-18 |
| K881876 | DYNAMIC CRUCIATE TESTER | Dyonics, Inc. | LYH | Class I | 1988-11-17 |
| K881800 | BCS NO. 1, BODY CARE SYSTEM | M & A Vertrieb, Liske Und Methling GM | IRT | Class II | 1988-11-16 |
| K884123 | AMOS BOY LIFT CHAIR | Howard N. Amos Design & Mfg. | INO | Class II | 1988-11-16 |
| K883913 | LA MASSEUSE | Sobel Shipping Co., Inc. | IRO | Class I | 1988-11-16 |
| K881917 | FLUIDAIR | Kinetic Concepts, Inc. | INX | Class II | 1988-11-14 |
| K884255 | CONCEPT CCT-5200, THERMAL THERAPY SYSTEM | Concept, Inc. | ILO | Class II | 1988-11-08 |
| K882974 | FORCE GUARD I | Boulder Impact Monitors, Inc. | IRN | Class II | 1988-11-04 |
| K882151 | PORT-O-HEAT, MODEL 0100 | Arthotronics, Inc. | IRT | Class II | 1988-11-04 |
| K883893 | OMNISOUND(TM) 3000 | Physio Technology, Inc. | IMG | Class II | 1988-11-01 |
| K883187 | SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM | Intl. Health Technology, Inc. | ILJ | Class II | 1988-10-27 |
| K883192 | SMI 3000 AIRBED | Smi Patientcare, Inc. | IOQ | Class II | 1988-10-26 |
| K881843 | PEDIATRIC HOSPITAL BED | The Medical Group, Inc. | IOQ | Class II | 1988-10-26 |
| K884052 | GILLUM'S WHEELCHAIR WIDTH REDUCING ATTACHMENT | Professional Service Unltd. | KNN | Class I | 1988-10-26 |
| K883131 | BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000 | Advanced Mechanical Technology, Inc. | KHX | Class I | 1988-10-24 |
| K883198 | BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM | Advanced Mechanical Technology, Inc. | KHX | Class I | 1988-10-24 |
| K883130 | BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000 | Advanced Mechanical Technology, Inc. | KHX | Class I | 1988-10-24 |
| K883129 | BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000 | Advanced Mechanical Technology, Inc. | KHX | Class I | 1988-10-24 |
| K882607 | ULTRAFLOTATION BED | Medical Flotation Systems, Inc. | IOQ | Class II | 1988-10-14 |
| K883659 | HLE-1000 HIGH/LOW TREATMENT TABLE | Rich-Mar Corp. | INQ | Class I | 1988-10-13 |
| K884110 | LTDT PATIENT LIFTER | Devine Medical Products | ILK | Class II | 1988-10-13 |
| K881862 | THERMO-BODY-WRAP SYSTEM | Thermo Body Wrap Systems, Inc. | IRT | Class II | 1988-10-13 |
| K883681 | DAS SPORT PUMP(TM) | D.A. Schulman, Inc. | ILO | Class II | 1988-09-30 |
| K883966 | HARE COLD PACK | Dyna Industries, Inc. | IMD | Class I | 1988-09-30 |
| K883127 | MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLY | Advanced Mechanical Technology, Inc. | KHX | Class I | 1988-09-30 |
| K883309 | MULTI-CARE CHAIR | Mid-Canada Medical | INM | Class I | 1988-09-30 |
| K874688 | FLOWTRON AC200/2 | Huntleigh Technology, Inc. | IRP | Class II | 1988-09-23 |
| K882310 | DUAL-TEMP(TM) COOLING/WARMING UNIT | Seabrook Medical Systems, Inc. | ILO | Class II | 1988-09-23 |
| K883308 | PARKER BATHING SYSTEM | Mid-Canada Medical | ILJ | Class II | 1988-09-22 |
| K880362 | MODEL #1553 RECLINER INTERFACE | Invacare Corp. | ITI | Class II | 1988-09-19 |
| K880364 | MODEL #1555 REMOTE JOYSTICK | Invacare Corp. | ITI | Class II | 1988-09-19 |
| K880361 | MODEL #1552 ATTENDANT CONTROL OPTION | Invacare Corp. | ITI | Class II | 1988-09-19 |
| K880360 | MODEL #1551 SWITCH CONTROL INTERFACE UNIT | Invacare Corp. | ITI | Class II | 1988-09-19 |
| K880363 | MODEL #1554 PNEUMATIC SWITCH | Invacare Corp. | ITI | Class II | 1988-09-19 |
| K880365 | MODEL #1556 HEAVY-DUTY JOYSTICK | Invacare Corp. | ITI | Class II | 1988-09-19 |
| K883674 | MANUAL SWING ARM | Rolcontrol Products, Co., Inc. | ITI | Class II | 1988-09-13 |
| K883671 | 805 POWER CHAIR CONVERSION SYSTEM | Rolcontrol Products, Co., Inc. | ITI | Class II | 1988-09-13 |
| K883672 | PARALYZED VETERANS OF AMERICA POWER RECLINER | Rolcontrol Products, Co., Inc. | ITI | Class II | 1988-09-13 |
| K883679 | WHEELS-OFF QUICK RELEASE AXLE SYSTEM | Rolcontrol Products, Co., Inc. | KNN | Class I | 1988-09-13 |
| K883673 | POWER MECHANICAL RECLINER | Rolcontrol Products, Co., Inc. | ITI | Class II | 1988-09-13 |
| K883678 | 4007 MODEL RECLINER CONTROLLER | Rolcontrol Products, Co., Inc. | ITI | Class II | 1988-09-13 |
| K883064 | MASSAGE MACHINE (CAT. EM-01 ULE 111756) | Emrad, Ltd. | ISA | Class I | 1988-08-23 |
| K883357 | MODEL 1080 ROLLER MASSAGE TABLE | Excel Medical Products, Inc. | JFB | Class II | 1988-08-23 |
| K882900 | MECHANICAL TABLES AND ACCESSORIES | Rifton | INW | Class I | 1988-08-19 |
| K883228 | SONICATOR 720 (MODEL ME720) | Mettler Electronics Corp. | IMI | Class II | 1988-08-18 |
| K883275 | SWEDE ELITE, MECHANICAL WHEELCHAIR | Etac Us, Inc. | IOR | Class I | 1988-08-18 |
| K883339 | CLIPPER POWER DRIVE WHEELCHAIR | Everest & Jennings, Inc. | ITI | Class II | 1988-08-18 |
| K882229 | AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS | Biologics Intl., Inc. | IOQ | Class II | 1988-08-16 |
| K882264 | BATTLE CREEK PILLOW | Battle Creek Equipment Co. | IQK | Class I | 1988-08-09 |
| K874212 | VERIMED MYO/PREMS | Verimed Holdings, Inc. | IPF | Class II | 1988-08-08 |
| K874417 | TASH PILOT SYSTEM | Everest & Jennings, Inc. | ITI | Class II | 1988-08-03 |
| K883034 | WHEELCHAIR BCW 6000 | O'Tec Corp. | IOR | Class I | 1988-08-02 |
| K882917 | HI-LO TABLE, MODEL 820-05 | Tri W-G, Inc. | JFB | Class II | 1988-07-28 |
| K882916 | MOTORIZED PARALLEL BAR, MODEL 110 | Tri W-G, Inc. | BXB | Class I | 1988-07-28 |
| K881081 | DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGER | Ferguson Medical | LYG | Class I | 1988-07-21 |
| K881284 | COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE | Nathaniel Gould Diagnostics, Inc. | JFC | Class I | 1988-07-21 |
| K881080 | DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER | Ferguson Medical | LYG | Class I | 1988-07-21 |
| K881461 | MULTIMODE(TM) INTERFACE SYSTEM FOR MEYRA WHEELCH. | Dufco Electronics, Inc. | ITI | Class II | 1988-07-18 |
| K881462 | UNIMODE(TM) POWER MODULE SYSTEM | Dufco Electronics, Inc. | ITI | Class II | 1988-07-18 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.