Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 51
- Latest Decision
- 1983-11-03
Clearances · page 48 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K833437 | ORTHOPEDIC STOCKINETTE | Northern Medical Surgical, Inc. | ILG | Class I | 1983-11-03 |
| K833177 | GLOSSECTOMY FEEDING SPOONS | Maddak, Inc. | ILC | Class I | 1983-10-31 |
| K833195 | UMBRELLA WALKER | Convaid Products, Inc. | ITJ | Class I | 1983-10-27 |
| K832546 | MARK V HIGH VOLTAGE GALVANIC STIMULATORR | Orthion Corp. | IPF | Class II | 1983-10-14 |
| K833090 | SENSORY ROLLER MASSAGER | Maddak, Inc. | ISA | Class I | 1983-10-14 |
| K832829 | NEO-FLOAT NEONATAL FLOTATION SYS & RHYT | Clinical Data Instruments, Inc. | IOQ | Class II | 1983-10-04 |
| K832969 | WALKING CANE | Maddak, Inc. | IPS | Class I | 1983-09-29 |
| K832968 | PEDAL EXERCISER | Maddak, Inc. | ION | Class I | 1983-09-29 |
| K832970 | CANE REACHER | Maddak, Inc. | IPS | Class I | 1983-09-29 |
| K832820 | MUL-T-BLANKET | Gaymar Industries, Inc. | ILO | Class II | 1983-09-26 |
| K832819 | MUL-T-PAD | Gaymar Industries, Inc. | ILO | Class II | 1983-09-26 |
| K832770 | LANE ONE | Loredan Biomedical, Inc. | IKK | Class II | 1983-09-26 |
| K832745 | OC3 FLYER | Intl. Medical Equipment Corp. | ITI | Class II | 1983-09-20 |
| K832741 | JASON CERVICAL ORTHOSIS | Orthomedics | IQF | Class I | 1983-09-20 |
| K832696 | RISER STANDUP WHEELCHAIR | Imex Medical Systems, Inc. | IPL | Class II | 1983-09-20 |
| K832742 | EXTENSION CONTROL KNEE ORTHOSIS | Orthomedics | ITM | Class I | 1983-09-20 |
| K832685 | WHEELCHAIR-VARIOUS MODELS | Health America | IOR | Class I | 1983-09-20 |
| K832804 | SESAM TABLE | Electro-Med Health Industries, Inc. | INQ | Class I | 1983-09-20 |
| K832727 | MOBIE | Everest & Jennings, Inc. | INI | Class II | 1983-09-20 |
| K832803 | STEAM PAK MOIST HEAT | Electro-Med Health Industries, Inc. | IMA | Class I | 1983-09-20 |
| K832193 | NICE PACK | Universal Medical Instrument Corp. | IME | Class I | 1983-08-31 |
| K832511 | RECLINING WHEELS | Reclining Wheels | INN | Class I | 1983-08-31 |
| K832059 | IONOPHORELIC SWEAT STIM. CHLORIDE- | Medtronic Vascular | KTB | Class II | 1983-08-24 |
| K831800 | TEXAS INTERFACE PRESSURE EVALUATOR-TIPE | Tee-Kay Applied Technology | JFC | Class I | 1983-08-16 |
| K832237 | ORTHOPEDIC CASTING TAPE MAXCAST | Cutter Laboratories, Inc. | ITG | Class I | 1983-08-16 |
| K832464 | MASSAGE TABLE AAT-100 | R&D Systems, Inc. | JFB | Class II | 1983-08-16 |
| K832322 | BASE ONLY, TORONTO CHAIR | Intl. Medical Equipment Corp. | IQC | Class II | 1983-08-12 |
| K832325 | BASE ONLY, POWER WHEELCHAIR | Intl. Medical Equipment Corp. | ITI | Class II | 1983-08-12 |
| K832224 | NOVA LIFT CHAIR | Nova Health Concepts, Inc. | INO | Class II | 1983-08-12 |
| K832144 | SPLINT WOOD | Vermont Wood Industries, Inc. | ILH | Class I | 1983-08-01 |
| K832161 | AMBULIZER MODEL MC-5 | Mobilizer Medical Products, Inc. | IOR | Class I | 1983-08-01 |
| K831473 | ULTRA PULSATOR MF | Medelco , Ltd. | IPF | Class II | 1983-07-26 |
| K831510 | FREEDOM 19 RECREATIONAL WHEELCHAIR | Carbonite Corp. | IQC | Class II | 1983-07-19 |
| K831320 | DRIONIC | General Medical Co. | EGJ | Class II | 1983-07-19 |
| K832001 | HEAD-IMMOBILIZER | Int'L Safety Corp. | IQK | Class I | 1983-07-12 |
| K830702 | NICOLET EMG SATELLITE | Nicolet Biomedical Instruments | IKN | Class II | 1983-07-12 |
| K831699 | STRESS MACHINE | Dr. William F. Curran | ISA | Class I | 1983-07-12 |
| K831910 | STRYKER LEG EXERCISER | Stryker Corp. | BXB | Class I | 1983-07-12 |
| K832057 | NURSE CALL BUTTON | Qa Alert Systems | IQA | Class II | 1983-07-12 |
| K830650 | SUPPORT PRODUCTS EXAMPLE PROSET CAST | Isopedix Corp. | ITG | Class I | 1983-07-07 |
| K831899 | ENSWELL | Dr. Micheal A. Sabia | IME | Class I | 1983-07-07 |
| K831889 | SURGEON'S CHOICE CRUTCH HANDLE | W.K. Wheeler, Inc. | INP | Class I | 1983-07-07 |
| K831492 | YESONA PLASTER OF PARIS BANDAGE | Watson Phillips Y Cia. Sucs., S.A. DE C.V. | ITG | Class I | 1983-06-30 |
| K831549 | ARM SLINGS | Fred Sammons, Inc. | ILI | Class I | 1983-06-30 |
| K831548 | SPLINTS | Fred Sammons, Inc. | ILH | Class I | 1983-06-27 |
| K831762 | SITZ BATH, SINGLE PATIENT USE #8100 | Lsl Industries, Inc. | KTC | Class I | 1983-06-24 |
| K831044 | LIMITED MOTION FUNCTIONAL KNEE BRACE | Orthopedic Systems, Inc. | ITQ | Class I | 1983-06-24 |
| K831706 | SATO FAMILY FIRST AID KIT | Food and Drug Service, Inc. | ILI | Class I | 1983-06-24 |
| K831690 | IPOS ANTI-ADDUCTUS SHOE | Ipos Luneburg | KNP | Class I | 1983-06-24 |
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | Fred Sammons, Inc. | IOD | Class I | 1983-06-24 |
| K831135 | SAUNDERS #7080 CERVICAL TRACTION SYS | Chattanooga Group, Inc. | ILZ | Class I | 1983-06-24 |
| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Fred Sammons, Inc. | IQI | Class I | 1983-06-24 |
| K831543 | ADJUST. WEIGHTS-BK5171-05,10,20 BEOK | Fred Sammons, Inc. | ION | Class I | 1983-06-24 |
| K831003 | MEASURE-UP MUSCLE STIMULATOR | Measure-Up Intl., Inc. | IPF | Class II | 1983-06-20 |
| K830793 | PATIENT GUIDED ELBOW & SHOULDER EXERC | Richard'S Medical Equip., Inc. | BXB | Class I | 1983-06-16 |
| K831582 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | IQK | Class I | 1983-06-15 |
| K831615 | DROP FOOT BRACE | Edward Dilauro, Jr. | IQI | Class I | 1983-06-15 |
| K831545 | REACHER & DOOR OPENER | Fred Sammons, Inc. | IKW | Class I | 1983-06-08 |
| K831552 | SORBOTHANE VISCO INNER SOLE PAD | Fred Sammons, Inc. | KNP | Class I | 1983-06-08 |
| K831547 | RAISED TOILET SEATS & NAIL CLIPPERS | Fred Sammons, Inc. | ILS | Class I | 1983-06-08 |
| K831539 | ECONOMY PLASTIC SOCK-BK2084-AID | Fred Sammons, Inc. | ILD | Class I | 1983-06-08 |
| K822413 | WEYLAND EXTENSION VIBRATOR | Medical Management Service, Inc. | JFB | Class II | 1983-06-08 |
| K831540 | COMPRESSOGRIP ELASTIC STUMP SHRINKER# | Fred Sammons, Inc. | ILG | Class I | 1983-06-08 |
| K831538 | DELUXE ADJUST-ANGLE BOARD-BK4066 | Fred Sammons, Inc. | ION | Class I | 1983-06-08 |
| K831394 | SOMATRON | Somatron Co. | JFB | Class II | 1983-06-08 |
| K831546 | ADAPTIVE PENS & LAP DESK | Fred Sammons, Inc. | ILP | Class I | 1983-06-08 |
| K830853 | LAVATORY SEAT HEIGHTENER | Lic-Orthion | ILS | Class I | 1983-06-08 |
| K830981 | MICROPAK MOIST HEAT PAD | Micropak Manufacturers, Inc. | IME | Class I | 1983-06-03 |
| K831541 | TUB TRANSFER BENCH BK6481 | Fred Sammons, Inc. | IKX | Class I | 1983-06-02 |
| K831206 | ARUBI FLATTER & ARUBI FLATTER-S | Kc Export Management Co. | ISA | Class I | 1983-06-02 |
| K830715 | NORELCO VIBRATING BOARD V900 | North American Philips Corp. | IRO | Class I | 1983-05-25 |
| K830784 | WALK N ROLL | Meta-Morris | ITJ | Class I | 1983-05-25 |
| K831310 | BRACE C.T. | Innovation Sports, Inc. | ITQ | Class I | 1983-05-16 |
| K831247 | SAFE-SEAT WHEELCHAIR CUSHION | D.A. Schulman, Inc. | KIC | Class I | 1983-05-16 |
| K831093 | APELLO, PERSONAL HEALTH SUPPORT SYS. | Almicro Electronics, Inc. | ILQ | Class II | 1983-05-16 |
| K830425 | TOILET SEAT RAISED | Maddak, Inc. | ILS | Class I | 1983-05-09 |
| K831149 | PERSONAL KNEE CRUTCH PAD | Tecnol New Jersey Wound Care, Inc. | INP | Class I | 1983-05-03 |
| K830426 | INFLATABLE INVALID RING | Maddak, Inc. | KIC | Class I | 1983-04-28 |
| K831033 | GIREX | Lancer Assoc. | ION | Class I | 1983-04-27 |
| K830974 | SUTTER CPM 5000 | Sutter Biomedical, Inc. | JFA | Class I | 1983-04-12 |
| K823849 | FREEDOM | Carbonite Corp. | IOR | Class I | 1983-04-12 |
| K830875 | S & W MODEL 29 | S & W Enterprises, Inc. | JFB | Class II | 1983-04-08 |
| K830874 | S & W MODEL SW 37 | S & W Enterprises, Inc. | INQ | Class I | 1983-04-08 |
| K830849 | OB TILT | Lic-Orthion | INQ | Class I | 1983-04-05 |
| K830852 | SHOWER STOOL W/HANDLES | Lic-Orthion | ILS | Class I | 1983-04-05 |
| K830848 | RESI-WALKER | Lic-Orthion | ITJ | Class I | 1983-04-05 |
| K830854 | COLLAPSABLE LAVATORY SEAT HEIGHTENER | Lic-Orthion | ILC | Class I | 1983-04-05 |
| K830842 | OB HELP ARM | Lic-Orthion | ILE | Class I | 1983-04-05 |
| K830850 | OB TRIPP TRANSPORT CHAIR | Lic-Orthion | INM | Class I | 1983-04-05 |
| K830851 | BATH TUB SEAT & BATH BOARD | Lic-Orthion | ILC | Class I | 1983-04-05 |
| K830855 | SESAM TREATMENT TABLE | Lic-Orthion | INQ | Class I | 1983-04-05 |
| K830427 | ARM CUSHION | Maddak, Inc. | KIC | Class I | 1983-03-29 |
| K830757 | HOT/ICE | Thermo Temp, Inc. | ILO | Class II | 1983-03-29 |
| K830289 | PDB II | J.A. Gerber Therapeutical, Ltd. | INQ | Class I | 1983-03-25 |
| K830316 | UNIFLEX | Buckman Consultants | BXB | Class I | 1983-03-24 |
| K830649 | SUTTER CPM 2000 | Sutter Biomedical, Inc. | BXB | Class I | 1983-03-17 |
| K830633 | LIC TILT BED | Century Manufacturing Co. | INQ | Class I | 1983-03-10 |
| K830345 | SCOOTER, VEHICLE MOTORIZED | Amigo Sales, Inc. | INI | Class II | 1983-03-10 |
| K830416 | ICY COLD ICE CAP | Ladora Ent. | IME | Class I | 1983-03-10 |
| K830055 | RICH-MAR HV 20 | Rich-Mar Corp. | IPF | Class II | 1983-03-10 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.