Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 48
- Latest Decision
- 1978-10-17
Clearances · page 55 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K781350 | OBJECTS PRECISION HANDLING TEST KIT | Metro. Hospital & Health Center | ION | Class I | 1978-10-17 |
| K781317 | ULTRASONIC THERAPY APPARATUS, 407 | General Theraphysical, Inc. | IMI | Class II | 1978-10-03 |
| K781319 | THERAPY APPAR. 422 INTERFERENTIAL | General Theraphysical, Inc. | IPF | Class II | 1978-10-03 |
| K781559 | LIFTING CHAIR & LIFTING LAVATORY SEAT | Motor Riser Chairs , Ltd. | INO | Class II | 1978-10-03 |
| K781315 | MUSCLE STIMULATION APPARATUS | General Theraphysical, Inc. | IPF | Class II | 1978-10-03 |
| K781318 | DYNATRON 406 ELECTROTHERAPY APPARATUS | General Theraphysical, Inc. | IPF | Class II | 1978-10-03 |
| K781614 | MOTOR RISER TOLIT LIFT | Motor Riser Chairs , Ltd. | ILS | Class I | 1978-10-03 |
| K781316 | PULSED AND CONTINUOUS SHORTWAVE APPAR. | General Theraphysical, Inc. | IMJ | Class II | 1978-09-27 |
| K781320 | SHORTWAVE THERAPY APPAR. CURAMED 401 | General Theraphysical, Inc. | IMJ | Class II | 1978-09-27 |
| K781139 | MUSCLE STIMULATOR, ELECTRONIC | Thor Medical Instruments, Inc. | IPF | Class II | 1978-09-26 |
| K781113 | MUSCLE STIMULATOR, ELECTRICAL | Rich-Mar Corp. | IPF | Class II | 1978-09-26 |
| K781399 | TECA MODEL B9 ELECTROMYOGRAPH | Teca, Inc. | IKN | Class II | 1978-09-20 |
| K781167 | STEMPLEX | Rich-Mar Corp. | IPF | Class II | 1978-09-15 |
| K780632 | MAXICEPTOR | Med General | ISB | Class II | 1978-08-14 |
| K781363 | CAST SHOE | Cutler Biomedical | IPG | Class I | 1978-08-14 |
| K780905 | LIMB COVER | Hydro-Med Products, Inc. | IPM | Class I | 1978-08-14 |
| K781205 | TOILET AID | Fred Sammons, Inc. | ILS | Class I | 1978-07-31 |
| K781198 | BOARD, SCOOTER | Fred Sammons, Inc. | KNL | Class I | 1978-07-31 |
| K781203 | TRAY, LAP, MOLDED | Fred Sammons, Inc. | KNO | Class I | 1978-07-31 |
| K781197 | STICK, UTILITY | Fred Sammons, Inc. | ILW | Class I | 1978-07-31 |
| K781195 | BAG, WALDER | Fred Sammons, Inc. | KNO | Class I | 1978-07-31 |
| K781201 | BOARD, TRANSFER, FENDER | Fred Sammons, Inc. | IKX | Class I | 1978-07-31 |
| K781194 | BAG, WHEELCHAIR | Fred Sammons, Inc. | KNO | Class I | 1978-07-31 |
| K781191 | SPORKS, PLASTIC, DISP. | Fred Sammons, Inc. | ILC | Class I | 1978-07-31 |
| K781196 | UTENSILS, WEIGHTED | Fred Sammons, Inc. | ILC | Class I | 1978-07-31 |
| K781200 | NAIL CLIPPERS, ONE-HANDED | Fred Sammons, Inc. | ILW | Class I | 1978-07-31 |
| K781204 | BOOK HOLDER | Fred Sammons, Inc. | ILP | Class I | 1978-07-31 |
| K781206 | FOOT POSITIONER | Fred Sammons, Inc. | IQI | Class I | 1978-07-31 |
| K781192 | KNIFE, ROCKER, SLOTTED HANDLE | Fred Sammons, Inc. | ILC | Class I | 1978-07-31 |
| K781202 | VEST, SUPPORT, TRUNK | Fred Sammons, Inc. | KNO | Class I | 1978-07-31 |
| K781193 | KNIFE, LARGE HANDLE | Fred Sammons, Inc. | ILC | Class I | 1978-07-31 |
| K781199 | HOLDER, CARD, QUAD-QUIP | Fred Sammons, Inc. | ILT | Class I | 1978-07-31 |
| K780941 | CONDUCTIVE CUSHION | Markham Service Co., Inc. | KIC | Class I | 1978-07-27 |
| K781080 | GALVANATOR, MODEL 770 | Avra Corp. | IPF | Class II | 1978-07-07 |
| K781001 | CHAIRS WITH CASTORS | Orthopedic Equipment Co., Inc. | INM | Class I | 1978-06-30 |
| K780979 | AIRSTIRRUP PNEUMATIC ANKLE BRACE | Aircast, Inc. | IQI | Class I | 1978-06-30 |
| K780994 | CERVICAL COLLAR | Fox Instruments, Inc. | IQK | Class I | 1978-06-30 |
| K780452 | THERA-PAK | Hydro-Med Products, Inc. | ILO | Class II | 1978-06-21 |
| K780935 | GRAB BAR | Orthopedic Equipment Co., Inc. | IKX | Class I | 1978-06-19 |
| K780391 | PODIATRIC MATERIAL | Crown Delta Corp. | MNE | Class I | 1978-06-14 |
| K780890 | CAPP TERMINAL DEVICE | Hosmer Dorrance Corp. | IQX | Class I | 1978-06-13 |
| K780892 | FRACTURE BRACING | Hosmer Dorrance Corp. | ITQ | Class I | 1978-06-13 |
| K780891 | POST-OPERATIVE HIP ORTHOSIS | Hosmer Dorrance Corp. | ITS | Class I | 1978-06-13 |
| K780541 | PRESSURE MODULES MODELS 1855 & 1856 | Life-Tech Instruments, Inc. | IKN | Class II | 1978-05-19 |
| K780402 | POWER STRIDER | Seidel Manufacturing, Inc. | ITI | Class II | 1978-05-12 |
| K780755 | SHORTWAVE DIATHERMY MODEL 802 | Birtcher Corp. | IMJ | Class II | 1978-05-12 |
| K780730 | FIGURETRIM | Jay-Mar INternational Enterprises, IN | ISB | Class II | 1978-05-09 |
| K780710 | AIR MASSAGE SYSTEM | Theracom C/O Arent, Fox, Kintner, Plotki | IRP | Class II | 1978-05-09 |
| K780683 | TISSUE PULSATOR | Pulsator Corp. | ISA | Class I | 1978-05-03 |
| K780426 | BODY WARMER | Q-Matic Corp. | IMD | Class I | 1978-04-27 |
| K780603 | COLD PACK | Abco Dealers, Inc. | IMD | Class I | 1978-04-21 |
| K780612 | STOCKINETTE, STERILE | Abco Dealers, Inc. | ILG | Class I | 1978-04-19 |
| K780617 | EQUALIZER | Ballert Orthopedic Corp. | IPG | Class I | 1978-04-18 |
| K780531 | MILLER TABLE | Victor John Manley | INW | Class I | 1978-04-13 |
| K780489 | SPINE BOARD | Marullo, Baldwin, Frieden, Gatewood, | IQF | Class I | 1978-04-12 |
| K780547 | STERILE ORTHOPEDIC STOCKINETTE | Alba-Waldensian, Inc. | ILG | Class I | 1978-04-10 |
| K780279 | ICE-PAK, PDI | Nice-Pak Products, Inc. | IMD | Class I | 1978-04-10 |
| K780312 | AUTONOM | Autonomic Equipment Supply Co, | KNM | Class I | 1978-04-05 |
| K780375 | PAVLIK HARNESS | Biomet, Inc. | IOZ | Class I | 1978-03-15 |
| K780227 | BANDAGE SPREADER BLOCK | Biomet, Inc. | ILZ | Class I | 1978-03-15 |
| K780195 | WHEELCHAIR MUFF | Orthopedic Equipment Co., Inc. | KNO | Class I | 1978-03-09 |
| K780229 | ABDOMINAL BELT | Biomet, Inc. | KTD | Class I | 1978-03-02 |
| K780225 | ORTHOSISES DEVICES | Biomet, Inc. | IQI | Class I | 1978-02-24 |
| K780296 | THERAPY SCOOTER | Convaid Product Development | KNL | Class I | 1978-02-24 |
| K780234 | TRACTION BELT, PELVIC | Biomet, Inc. | ILZ | Class I | 1978-02-23 |
| K780014 | COLD CYCLE, CHEMICAL COLD PACK | Signal West | IMD | Class I | 1978-02-21 |
| K780226 | SPREADER BARS | Biomet, Inc. | ILZ | Class I | 1978-02-17 |
| K780192 | LEGREST, ELEVATING | Orthopedic Equipment Co., Inc. | KNN | Class I | 1978-02-14 |
| K780194 | TOE LOOPS | Orthopedic Equipment Co., Inc. | KNO | Class I | 1978-02-14 |
| K780193 | HEEL LOOPS | Orthopedic Equipment Co., Inc. | KNO | Class I | 1978-02-14 |
| K780191 | STRAP, LEGREST | Orthopedic Equipment Co., Inc. | KNO | Class I | 1978-02-14 |
| K780183 | WHEELCHAIRS, MECHANICAL | Orthopedic Equipment Co., Inc. | IOR | Class I | 1978-02-13 |
| K772404 | FINGER EXERCISE BOARD | Fred Sammons, Inc. | ION | Class I | 1978-02-13 |
| K780184 | WHEELCHAIR ACCESSORIES | Orthopedic Equipment Co., Inc. | IMX | Class I | 1978-02-13 |
| K780133 | MUSCLE STIMULATOR, ELECTRICAL | De Electronics | IPF | Class II | 1978-02-02 |
| K772414 | SANDBAGS, VARIOUS WEIGHTS | Fred Sammons, Inc. | IOD | Class I | 1978-02-01 |
| K780136 | COLLAR, CERVICAL, SPLIT | Richard'S Medical Equip., Inc. | IQK | Class I | 1978-01-31 |
| K780085 | CANE/REACHER | Fred Sammons, Inc. | IPS | Class I | 1978-01-30 |
| K780053 | BRACE, TENNIS ELBOW | Bd Becton Dickinson Vacutainer Systems Preanalytic | IQI | Class I | 1978-01-17 |
| K772287 | MUSCLE STIMULATOR | Rich-Mar Corp. | IMG | Class II | 1978-01-13 |
| K772416 | PRE-FORMED SPLINT BLANKS | Fred Sammons, Inc. | ILH | Class I | 1978-01-05 |
| K772410 | RESTING PAN SPLINTS | Fred Sammons, Inc. | ILH | Class I | 1978-01-05 |
| K772401 | LAP BOARD W/RIM | Fred Sammons, Inc. | IMX | Class I | 1978-01-05 |
| K772417 | SLIDING BOARD | Fred Sammons, Inc. | IKX | Class I | 1978-01-05 |
| K772421 | WHEELCHAIR BELT | Fred Sammons, Inc. | IQB | Class I | 1978-01-05 |
| K772420 | REAR FASTENING SAFETY STRAP | Fred Sammons, Inc. | IQB | Class I | 1978-01-05 |
| K772411 | PLATFORM SPLINTS | Fred Sammons, Inc. | ILH | Class I | 1978-01-05 |
| K772269 | SETUP WALKER ADJUSTABLE | Med Fusion Systems, Inc. | ITQ | Class I | 1977-12-20 |
| K772271 | WALKER FOLDING ADJUSTABLE | Med Fusion Systems, Inc. | ITQ | Class I | 1977-12-20 |
| K772267 | QUADRAPLEGIC WALKING AID | Med Fusion Systems, Inc. | IPS | Class I | 1977-12-20 |
| K772268 | DEMI-WALKER (REGULAR) | Med Fusion Systems, Inc. | ITQ | Class I | 1977-12-20 |
| K772270 | SETUP WALKER OVER TOILET CONSTRUC. | Med Fusion Systems, Inc. | ITQ | Class I | 1977-12-20 |
| K772154 | CERVICAL TRACTION DIV., PNEUMATIC | Jobst | ITH | Class II | 1977-11-30 |
| K772005 | MYOTONE EMG MONITOR | Micro Tronics Corp. | IKN | Class II | 1977-11-23 |
| K772049 | WALKING AID | Guardian Products Co., Inc. | ITJ | Class I | 1977-11-11 |
| K771660 | KWICK KOOLER | World Trade Assoc. | IMD | Class I | 1977-11-07 |
| K771970 | WHIRLPOOL BATH MODEL 50 | Dazey Products Co. | ILJ | Class II | 1977-11-02 |
| K771966 | VIBRO BATH MODEL FS-1 | Dazey Products Co. | ILJ | Class II | 1977-11-02 |
| K771969 | TURBO-JET MODEL 76 | Dazey Products Co. | ILJ | Class II | 1977-11-02 |
| K771967 | WHIRLPOOL BATH MODEL 2270 | Dazey Products Co. | ILJ | Class II | 1977-10-28 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.