Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 31
- Latest Decision
- 1989-11-08
Clearances · page 39 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K896256 | REFLUX BED | Cozcon, Inc. | INW | Class I | 1989-11-08 |
| K884651 | ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000 | Biomedical Life Systems, Inc. | IPF | Class II | 1989-11-06 |
| K895671 | STIMTRAC II CATALOG NUMBER 78-8500 | Stimtech Products | IPF | Class II | 1989-11-06 |
| K893851 | THERASTIM | Physiodynamics, Inc. | IPF | Class II | 1989-11-06 |
| K894154 | METABOLIC SYSTEMS | Cybex | ISD | Class II | 1989-10-24 |
| K895596 | FORTRESS 1000FS ADD-ON POWER UNIT | Fortress Scientific , Ltd. | ITI | Class II | 1989-10-23 |
| K891458 | SW 803 LOW FREQUENCY STIMULATOR DANA TOUCH | Back IN Action, Inc. | IPF | Class II | 1989-10-20 |
| K882386 | AGAR 3K NEUROMUSCULAR STIMULATOR | Solcoor, Inc. | IPF | Class II | 1989-10-18 |
| K890434 | EMS 300 MUSCLE STIMULATORS | Paranamics, Inc. | IPF | Class II | 1989-10-17 |
| K881777 | LIKON | Northwood Intl., Corp. | IPF | Class II | 1989-10-16 |
| K882387 | AGAR 4000 NEUROMUSCULAR STIMULATOR | Solcoor, Inc. | IPF | Class II | 1989-10-16 |
| K895382 | VIBRA-TRAC TRACTION TABLE | Vibra-Trac Industries | ILZ | Class I | 1989-10-16 |
| K895692 | FORTRESS MODEL 2001LX ELECTRIC 3-WHEELER | Fortress Scientific , Ltd. | INI | Class II | 1989-10-16 |
| K893964 | SPECTRASTIM TM 1000 | Therapeutic Technologies, Inc. | IPF | Class II | 1989-10-06 |
| K894907 | MARK IV HAND, THUMB AND WRIST (CPM) UNIT | Innovative Medical Engineering, Inc. | BXB | Class I | 1989-10-06 |
| K895693 | FORTRESS 2000FS 3-WHEEL SCOOTER | Fortress Scientific , Ltd. | INI | Class II | 1989-10-05 |
| K895595 | FORTRESS 655FS POWER WHEELCHAIR | Fortress Scientific , Ltd. | ITI | Class II | 1989-10-05 |
| K895694 | FORTRESS MODEL 2200FS FRONT WHEEL DRIVE SCOOTER | Fortress Scientific , Ltd. | INI | Class II | 1989-10-03 |
| K895343 | PRENATAL WEDGE | Kay Ent. | JFB | Class II | 1989-09-29 |
| K895398 | BIO-COORDINATOR SYSTEM | Bio-Harmonizer, Inc. | IKK | Class II | 1989-09-28 |
| K895384 | CALIFORNIA COMFORT FOUR WHEEL | Jubilee Scooters, Inc. | IQC | Class II | 1989-09-18 |
| K895236 | MEDX REHABILITATION MACHINE | Medx Corp. | IKK | Class II | 1989-09-14 |
| K890178 | WHEELCHAIR STUMP SUPPORT | Gerber Chair Mates, Inc. | KNN | Class I | 1989-09-11 |
| K895016 | MODEL #510/515 GENERAL TRANSPORT STRETCHER | Midmark Corp. | INW | Class I | 1989-09-11 |
| K895165 | ZIGGY MEDICHAIR | Laszlo Corp. | INM | Class I | 1989-09-11 |
| K894770 | PERSONAL BACK WITH FIP KIT | Canadian Posture and Seating Centre, Inc. | KNN | Class I | 1989-09-11 |
| K895015 | ARTROMOT(TM) CPM DEVICES | Buckman Co., Inc. | BXB | Class I | 1989-09-11 |
| K875317 | ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID | Electro Therapeutic Devices, Inc. | IPF | Class II | 1989-09-08 |
| K894960 | E.Z. LOCK WHEELCHAIR RESTRAINT DEVICE | E.Z. Lock, Inc. | KNN | Class I | 1989-09-05 |
| K894987 | MODEL #520/525 ED/RECOVERY STRETCHER | Medmark, Inc. | INW | Class I | 1989-09-05 |
| K894926 | STAT-PAD | Hettel Accessories, Inc. | IMD | Class I | 1989-09-05 |
| K892791 | PATIENT EXAMINATION GLOVES (LATEX) | Union Industrial Co., Ltd. | IMM | Class I | 1989-08-24 |
| K890586 | INFRARED DELUXE | Healthteam | ILY | Class II | 1989-08-22 |
| K890585 | INFRARED HEX | Healthteam | ILY | Class II | 1989-08-22 |
| K894723 | SYSTEM 2500 MEDICAL WATERBED | Dermanetics Corp. | IOQ | Class II | 1989-08-17 |
| K894353 | ORTHODERM CONVERTIBLE | Health Products, Inc. | IOQ | Class II | 1989-08-09 |
| K893950 | VENTIPRESS 24 AND 14 PRESSURE VENTILATOR | Ventipress OY | IRP | Class II | 1989-08-03 |
| K894422 | TUFFCARE MEDICAL PRODUCTS WHEELCHAIR | Tuffman Industries | IOR | Class I | 1989-08-03 |
| K894346 | D88VS WHEELCHAIR POWER SYSTEM | Damaco | ITI | Class II | 1989-08-03 |
| K894435 | VAX-T PELVIC TRACTION BELT | Vat-Tech, Inc. | ITH | Class II | 1989-08-03 |
| K894344 | ELECTRO-LITE POWER WHEELCHAIR | Damaco | ITI | Class II | 1989-07-28 |
| K893032 | PACER R 9 TREADMILL | Pacer Industries, Inc. | IOL | Class I | 1989-07-27 |
| K894345 | ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR | Damaco | IOR | Class I | 1989-07-27 |
| K894112 | RAOMER | Niagara Corp. | INI | Class II | 1989-07-25 |
| K894136 | WORLD CHAIR | Invacare Corp. | IOR | Class I | 1989-07-25 |
| K891603 | BODY COOLER OR COOLVEST OR ALPHA BODY COOLER | Alpha Rehabilitation Products | ILO | Class II | 1989-07-25 |
| K893801 | M.F.S. LOW AIR LOSS PULSATING BED | Medical Flotation Systems, Inc. | IOQ | Class II | 1989-07-25 |
| K894017 | POWER PODIATRY CHAIR/TABLE #414, #416 & #417 | Midmark Corp. | INQ | Class I | 1989-07-14 |
| K893614 | AEROMAT MRS-1000 | Integrated Therapy Products, Inc. | IOQ | Class II | 1989-06-22 |
| K893706 | COLD/HOT FLUID RADIATION PAD NEUTECH | Burke, Inc. | ILO | Class II | 1989-06-22 |
| K893708 | FLUIDIZED AIR BED | Gsi Development Co. | IOQ | Class II | 1989-06-22 |
| K881196 | AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL | Biometer Intl. A/S | IPF | Class II | 1989-06-16 |
| K893429 | ALPHA CONDOR | Alpha Unlimited, Inc. | INI | Class II | 1989-06-12 |
| K893428 | ALPHA SHOPPER | Alpha Unlimited, Inc. | ITI | Class II | 1989-06-12 |
| K893490 | HANDI-LIFT/VICTORY WHEELCHAIR LIFT | The Cheney Co. | ING | Class II | 1989-06-12 |
| K893544 | HANDI PORCH ELEVATOR & LIBERTY WHEELCHAIR LIFT | The Cheney Co. | ING | Class II | 1989-06-12 |
| K893473 | COMMUNI-CALL | Carepartners, Inc. | ILQ | Class II | 1989-06-09 |
| K890556 | TDP INFRARED HEAT LAMP | Toxicology Professionals, Inc. | ILY | Class II | 1989-06-09 |
| K893448 | TRU TRAC TRACTION TABLE | Tru-Trac | ITH | Class II | 1989-06-09 |
| K883781 | NICOLET NEUROPORT/ACE SYSTEM | Nicolet Instrument Corp. | IKN | Class II | 1989-06-05 |
| K893029 | OMRON TRAVEL MASSAGER, MODEL HM-01 | Omron Electronics, Inc. | ISA | Class I | 1989-05-31 |
| K891092 | TEMPTEK 5010 THERMAL COOLING BLANKET | Temptek, Inc. | ILO | Class II | 1989-05-26 |
| K893248 | ALPHA MALLARD | Alpha Unlimited, Inc. | INI | Class II | 1989-05-26 |
| K892669 | COMFORTRAC, CT90 & CT100 BI-PHASICS | Comfortrac Systems | ISA | Class I | 1989-05-26 |
| K893168 | SPINALATOR JS-1100 TRACTION UNIT | The Spinalator Co. | ITH | Class II | 1989-05-26 |
| K884396 | MODIFIED THER-A-PULSE UNIT | Westec Corp. | IPF | Class II | 1989-05-18 |
| K892700 | E65 35 PRONE STANDER | Rifton Equipment For the Handicapped | INW | Class I | 1989-05-09 |
| K892697 | E653 OBLONG ABDUCTION BLOCK | Rifton Equipment For the Handicapped | INW | Class I | 1989-05-09 |
| K892698 | E655 ADJUSTABLE ABDUCTION BLOCK W/HIP STABILIZER | Rifton Equipment For the Handicapped | INW | Class I | 1989-05-09 |
| K892699 | E613 PAIR OF SUPPORT BLOCKS | Rifton Equipment For the Handicapped | INW | Class I | 1989-05-09 |
| K890143 | ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON | Microcurrent Research, Inc. | NUW | Class II | 1989-05-01 |
| K885343 | STANDEX | Alt, Inc. | ION | Class I | 1989-05-01 |
| K882816 | PULSAR EM | Apex Medical, Inc. | ILX | Class II | 1989-04-27 |
| K885276 | MODEL L-2000 & L-500 CHIROPRACTIC TABLES | Lesarn Mfg., Ltd. | INQ | Class I | 1989-04-26 |
| K891871 | PHASER (SINGLE LINEAR MECHANICAL MASSAGE) | Monad Corp. | ISA | Class I | 1989-04-25 |
| K891345 | MOBILIMB CPM SHOULDER UNIT | Toronto Medical Corp. | BXB | Class I | 1989-04-24 |
| K890401 | GOLDEN MEAN MACHINE(TM) (CLASS 2) | Bennett Ergonomic Labs, Inc. | ISD | Class II | 1989-04-21 |
| K890853 | AQUA-PAD FOR MOIST OR DRY HEAT THERAPY | Ati | ILO | Class II | 1989-04-14 |
| K890852 | AQUA-BLANKET HYPER/HYPOHERMIA BLANKET | Ati | ILO | Class II | 1989-04-14 |
| K890695 | HI-RIDER WHEELCHAIR | Retec USA, Inc. | IPL | Class II | 1989-04-10 |
| K891394 | PM830 ELECTRIC MASSAGER | Back IN Action, Inc. | ISA | Class I | 1989-04-10 |
| K891151 | COOL 'N HEAT MACHINE | Kinetic Concepts, Inc. | ILO | Class II | 1989-04-06 |
| K891609 | CARRETTE 3 WHEELED MOTORIZED CART | Everest & Jennings, Inc. | INI | Class II | 1989-04-06 |
| K890602 | STANDING DANI WHEELSTAND | Davis Positioning Systems, Inc. | IPL | Class II | 1989-03-23 |
| K890838 | REHABOT-YM | Imex Health, Inc. | BXB | Class I | 1989-03-23 |
| K890147 | RICH-MAR CONDUCTIVE GEL II W/ALOE VERA | Rich-Mar Corp. | IPF | Class II | 1989-03-23 |
| K891152 | GRAND COOLING MACHINE | Kinetic Concepts, Inc. | ILO | Class II | 1989-03-23 |
| K890495 | NICOLET VIKING II SYSTEM | Nicolet Instrument Corp. | IKN | Class II | 1989-03-16 |
| K890793 | STARTRAC | Unisen, Inc. | IOL | Class I | 1989-03-16 |
| K884840 | B.A.C. 1000 MOBILE STANDING DEVICE | Luconex, Inc. | IPL | Class II | 1989-03-15 |
| K885212 | ARROW MICRO COMPUTER CONTROL | Invacare Corp. | ITI | Class II | 1989-03-15 |
| K885261 | ARROW MICRO COMPUTER CONTROL SWITCH & ENVIRON. SYS | Invacare Corp. | ITI | Class II | 1989-03-15 |
| K890935 | SYSTEM 3000 FLUIDIZED AIR BED | Dermanetics Corp. | IOQ | Class II | 1989-03-15 |
| K885182 | TOTAL KNEE CPM | Invacare Corp. | BXB | Class I | 1989-03-15 |
| K890924 | THERMO-PACK | Medical Manufacturers, Inc. | IMD | Class I | 1989-03-14 |
| K890923 | VITALON MATRESS MASSAGE MODEL M-MX | Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. | ISA | Class I | 1989-03-14 |
| K890596 | MED-A-CALL ASSIST DEVICE | Silent Call Corp. | IQA | Class II | 1989-03-14 |
| K881470 | SOKEN PLUS(TM) ELECTRONIC MUSCLE STIMULATOR | Rehab Medical Specialties, Inc. | IPF | Class II | 1989-03-10 |
| K874232 | MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000 | Health Systems Intl., Inc. | IPF | Class II | 1989-03-10 |
| K890723 | LANCER - MODULAR POWER BASE | Everest & Jennings, Inc. | ITI | Class II | 1989-03-02 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.