Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 46
- Latest Decision
- 1984-05-11
Clearances · page 47 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K841700 | WALK & ROLL | Maddak, Inc. | INM | Class I | 1984-05-11 |
| K841698 | HEAT PACK | Maddak, Inc. | IMA | Class I | 1984-05-10 |
| K841579 | MULTIPLEX I, INTERFERENTIAL CURRENT | Houwers Enterprises , Ltd. | IPF | Class II | 1984-05-10 |
| K841695 | CRAWLER | Maddak, Inc. | KNL | Class I | 1984-05-10 |
| K841725 | OSLO ARMCHAIR | Mondial, Inc. | INM | Class I | 1984-05-09 |
| K841594 | MOBILIZATIOIN TABLE | Chattanooga Group, Inc. | INQ | Class I | 1984-05-09 |
| K841674 | CONTINUOUS PASSIVE MOTION | Chattanooga Group, Inc. | BXB | Class I | 1984-05-09 |
| K841528 | CONVAID - SPEECH AID | Convaid , Ltd. | ILQ | Class II | 1984-05-09 |
| K841446 | INTELECT 200 THERAPEUTIC ULTRASOUND | Chattanooga Group, Inc. | IMI | Class II | 1984-05-09 |
| K841447 | INTELECT 210 PORTABLE ULTRASOUND | Chattanooga Group, Inc. | IMI | Class II | 1984-05-09 |
| K841697 | HYDRO-THERO PAD | Maddak, Inc. | IRT | Class II | 1984-05-09 |
| K841691 | SPLIT SEAT POSITIONING CHAIR | Maddak, Inc. | INN | Class I | 1984-05-09 |
| K841445 | INTELECT 205 PORTABLE ULTRASOUND UNIT | Chattanooga Group, Inc. | IMI | Class II | 1984-05-09 |
| K841382 | EMPI MODEL 712, LOGIX, NMS | Empi | IPF | Class II | 1984-05-07 |
| K841711 | MAC LEE SITZ BATH | Mac Lee Medical Products | KTC | Class I | 1984-05-07 |
| K841278 | OMNISTIM III INTERFERENTIAL THERAPY | Physio Technology, Inc. | IPF | Class II | 1984-04-24 |
| K840895 | ELECTRICAL NEURO-MUSCULAR STIMULATOR | Richards Medical Co., Inc. | IPF | Class II | 1984-04-24 |
| K841413 | HYDRA-GYM ATHLETICS INC. | Hydra Fitness Industries | BXB | Class I | 1984-04-18 |
| K841145 | TILT TABLE 53 | S & W Enterprises, Inc. | INQ | Class I | 1984-04-13 |
| K841112 | TTI REHABILATATION GYM SYS | Therapeutic Technologies, Inc. | IPF | Class II | 1984-04-04 |
| K840551 | MOBILIZER | Lossing Orthopedic, Inc. | ION | Class I | 1984-03-23 |
| K841100 | HP-20, 30, 40, 50 & 60 | Associated Mills, Inc. | IRT | Class II | 1984-03-23 |
| K840416 | HEXCELITE | Hexcel Medical | ITG | Class I | 1984-03-23 |
| K840112 | SPEECH TEACHER | Joseph A. Resnick | ILP | Class I | 1984-03-22 |
| K840866 | PORTASCOOT POWER SEAT | E.F. Brewer Co. | INI | Class II | 1984-03-19 |
| K840808 | ECU 1218 | Rehab Technology, Inc. | IQA | Class II | 1984-03-19 |
| K840472 | SYS MACRODUCT SWEAT COLLECTION SYS 3600 | Wescor, Inc. | KTB | Class II | 1984-03-19 |
| K840638 | PORTABLE TRANSIT CHAIR | Poirier S.A. | INM | Class I | 1984-03-16 |
| K840724 | MUSCLE STIMULATOR X-10 | Biostim, Inc. | IPF | Class II | 1984-03-05 |
| K840697 | CALM WATER FLOTATION HOSPITAL BED | Calm Handicap Supplies, Inc. | IOQ | Class II | 1984-02-27 |
| K840625 | UNION WHEELCHAIR | Poirier S.A. | IQC | Class II | 1984-02-27 |
| K840633 | AIRPORT WHEELCHAIR | Poirier S.A. | IOR | Class I | 1984-02-27 |
| K840629 | WHEELCHAIR ACCESSORIES | Poirier S.A. | KNN | Class I | 1984-02-27 |
| K840632 | HEMIPLEGIC WHEELCHAIR | Poirier S.A. | IQC | Class II | 1984-02-27 |
| K840628 | LARGE FRONT WHEELS WHEELCHAIR | Poirier S.A. | IQC | Class II | 1984-02-27 |
| K840624 | COMBI | Besam, Inc. | ITI | Class II | 1984-02-27 |
| K840635 | TRAINING WHEELCHAIR | Poirier S.A. | IQC | Class II | 1984-02-27 |
| K840637 | HOSPITALIER WHEELCHAIR | Poirier S.A. | IOR | Class I | 1984-02-27 |
| K840627 | AMPUTEE WHEELCHAIR | Poirier S.A. | IQC | Class II | 1984-02-27 |
| K840626 | VERTICALIBRE WHEELCHAIR | Poirier S.A. | IPL | Class II | 1984-02-27 |
| K840630 | POIRIER REGLADE WHEELCHAIR | Poirier S.A. | IQC | Class II | 1984-02-27 |
| K840631 | ARNAS WHEELCHAIR | Poirier S.A. | IQC | Class II | 1984-02-27 |
| K840636 | CHILDREN'S WHEELCHAIRS | Poirier S.A. | IQC | Class II | 1984-02-27 |
| K840640 | POSITELEC WHEELCHAIR | Poirier S.A. | ITI | Class II | 1984-02-27 |
| K840234 | POIRIER VARIABLE WHEELCHAIR | Poirier S.A. | IQC | Class II | 1984-02-27 |
| K840634 | OLYMPIC & BASKET WHEELCHAIRS | Poirier S.A. | IQC | Class II | 1984-02-27 |
| K840467 | NEUROMUSCULAR STIMULATOR 3105 | Medtronic Vascular | IPF | Class II | 1984-02-17 |
| K840478 | EMCO WHEELCHAIR | Emco Medical Supply | IOR | Class I | 1984-02-17 |
| K840346 | NEUROMUSCLAR II | Mentor Corp. | IPF | Class II | 1984-02-10 |
| K834462 | GENUCOM | Far Orthopedics, Inc. | LYH | Class I | 1984-02-09 |
| K840250 | CARRIER | Convaid Products, Inc. | LBE | Class I | 1984-02-09 |
| K840280 | ROAD RUNNER ELECTRIC TREADMILL | Battle Creek Equipment Co. | IOL | Class I | 1984-02-04 |
| K840282 | OVERHEAD WHIRLPOOL HAND SPA BRAND | Priest Enterprises, Inc. | ILJ | Class II | 1984-02-04 |
| K833311 | NITROGLYCERINE CONTAINER | Apothecary Products, Inc. | NXB | Class I | 1984-02-04 |
| K840024 | WHEELCHAIR MECHANICAL | Amico Lab, Inc. | IOR | Class I | 1984-01-30 |
| K840035 | HAYDAY IRRIT-EASER WAND | Hayday Irrit-Easer | ISA | Class I | 1984-01-30 |
| K834563 | EGERTON TURNING & TILTING BED | Kinetic Concepts, Inc. | IKZ | Class II | 1984-01-30 |
| K834552 | PREMIER | Everest & Jennings, Inc. | ITI | Class II | 1984-01-30 |
| K840148 | BMR-16 CLINIC MUSCLE STIMULATOR | Bio-Medical Research Corp. | IPF | Class II | 1984-01-30 |
| K840149 | BMR POWERSTIM | Bio-Medical Research Corp. | IPF | Class II | 1984-01-30 |
| K834203 | FLEXXR* CPM SYSTEM | Qarex Laboratories, Inc. | BXB | Class I | 1984-01-30 |
| K840147 | BMR-2 MUSCLE STIMULATOR | Bio-Medical Research Corp. | IPF | Class II | 1984-01-30 |
| K840196 | MINI-BEEP | C.F. Struck Corp. | INI | Class II | 1984-01-30 |
| K834498 | TRAIL CHAIR | Winchester Industries, Inc. | IQC | Class II | 1984-01-30 |
| K834583 | CLEAR LEADS-RADIOTRANSPARENT WIRES | Quinton, Inc. | IKD | Class II | 1984-01-30 |
| K834506 | PACESAVER & SCOUT | Burke, Inc. | INI | Class II | 1984-01-30 |
| K833944 | STERILE SOLUTION WARMER | National Fabtronix, Inc. | LHC | Class I | 1984-01-25 |
| K834344 | MED-OPEDIC SLEEP SYSTEM | Bemco Mattress Co. | INX | Class II | 1984-01-17 |
| K834507 | HYDROPULSE(GROSSAN);INFLAT TUBE MASS | Amrex-Zetron, Inc. | IRP | Class II | 1984-01-17 |
| K834517 | JAY CUSHION | Jay Medical, Ltd. | KIC | Class I | 1984-01-17 |
| K834360 | 3-D PASSIVE MOBILIZER | 3-D Orthopedic, Inc. | ISD | Class II | 1984-01-13 |
| K834103 | TABLE, MODELS 610,611 & 612 | Tri W-G, Inc. | INQ | Class I | 1984-01-13 |
| K834405 | TEC TRACTION MACHINE | Akron Medical Corp. | ITH | Class II | 1984-01-13 |
| K834293 | ELECTRONIC CELL ENERGIZER | Electronic Energy, Inc. | LBG | Class II | 1984-01-13 |
| K833927 | ELECTRO-MYOSCOPE 85 | Biomedical Design Instruments | IKN | Class II | 1983-12-27 |
| K834098 | STATIONARY EXERCISE BICYCLE | Engineering Dynamics Corp. | ISD | Class II | 1983-12-27 |
| K833839 | BIOTHERM | Trileen, Inc. | ILJ | Class II | 1983-12-27 |
| K832805 | BIONICARE STIMULATOR BIO-1 | Murray Electronics | IPF | Class II | 1983-12-23 |
| K833945 | COSMODYN-S INTERFERENTIAL MUSCLE STIM | Leo Unlimited, Inc. | IPF | Class II | 1983-12-23 |
| K834092 | MULTIPLE SOKEN 3 ELECTRON-MUSCLE STIM | Rehab Medical Specialties, Inc. | IPF | Class II | 1983-12-20 |
| K833808 | NUTRA-TONE 500 | Applied Optic Kinetics , Ltd. | IPF | Class II | 1983-12-12 |
| K833732 | NON WETTING UNDERCAST PADDING | American Medical Disposable, Inc. | ITG | Class I | 1983-12-12 |
| K832177 | PULSAIR MODEL SP-1 | Thermowave Medical Device Corp. | IRQ | Class I | 1983-12-09 |
| K833840 | MASSATOR-PEDIO | Trileen, Inc. | ISA | Class I | 1983-11-29 |
| K833869 | CHILD'S WALKER | Kaye Products, Inc. | ITJ | Class I | 1983-11-29 |
| K833870 | KNEE WALKER | Maddak, Inc. | ION | Class I | 1983-11-29 |
| K833370 | LINEAR VIBRATION A MCSHIRLEY PRODUCT | Mcshirley Products, Inc. | IRO | Class I | 1983-11-28 |
| K833564 | HOT/ICE DISPOSABLE BLANKET | Thermo Temp, Inc. | ILO | Class II | 1983-11-28 |
| K833631 | THERMAMED BATH | Bernlit Enterprises, Inc. | IMC | Class II | 1983-11-28 |
| K833868 | IPOS G.L.P. SYSTEM | Ipos Luneburg | KFX | Class II | 1983-11-28 |
| K832976 | BX-600 EMS | Bloomex International, Inc. | IPF | Class II | 1983-11-25 |
| K832988 | STAODYN EMS/PLUS | Staodynamics, Inc. | IPF | Class II | 1983-11-22 |
| K832642 | ALPHA-I | Johnson Flexgroup | LHC | Class I | 1983-11-21 |
| K832992 | SOFFBAN ORTHOPEDIC PADDING | Smith & Nephew, Inc. | ITG | Class I | 1983-11-14 |
| K833588 | VASCULAR LABORATORY TREADMILL VT1 | Medasonics, Inc. | IOL | Class I | 1983-11-14 |
| K832913 | BACK MASSAGER B-400 ADJUSTABLE | Pollenex Associated Mills, Inc. | ISA | Class I | 1983-11-07 |
| K832920 | INTERMITTENT COMPRESSION PUMPS | Chattanooga Group, Inc. | IRP | Class II | 1983-11-07 |
| K833249 | FITNESS | Fitness Equipment Co., Inc. | ION | Class I | 1983-11-07 |
| K832940 | ROTAGYM | I-Rep, Inc. | ISD | Class II | 1983-11-07 |
| K832990 | STIFNICK IMMOBILIZING COLLAR | Laerdal California, Inc. | IQK | Class I | 1983-11-07 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.