Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 49
- Latest Decision
- 1980-02-19
Clearances · page 54 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K800143 | DYNAMIC EXTENSOR SPLINT | Biomet, Inc. | ILH | Class I | 1980-02-19 |
| K800195 | COTTON UNDER CAST PADDING | Winn Hirsch & Assoc. | ITG | Class I | 1980-02-11 |
| K800068 | ELECTRICAL MUSCLE STIMULATOR (EMS) | Staodynamics, Inc. | IPF | Class II | 1980-02-05 |
| K792269 | WRIGHT DOW CORNING SOFTGOODS W/DOW | Dow Corning Wright | IPY | Class I | 1980-02-05 |
| K800072 | DIGITAL ELECTRONIC EXERCISER/PULSE MTR. | Sears, Roebuck & Co. | ISD | Class II | 1980-01-28 |
| K792641 | HYDRO PULSE MASSAGE | Hydro-Pulse Research, Inc. | ILJ | Class II | 1980-01-28 |
| K800076 | CRUTCH TIPS, PADS & HAND GRIPS | New World Imports, Inc. | INP | Class I | 1980-01-28 |
| K792642 | THE VARIABLE LOAD KENETIC ENERGIZER | W.F. Pogue | ION | Class I | 1980-01-28 |
| K800018 | BK-5203 FACILITATION VIBRATOR ELECTRIC | Fred Sammons, Inc. | IRO | Class I | 1980-01-21 |
| K800019 | BK-1544 BE OK SCOOP DISK | Fred Sammons, Inc. | ILC | Class I | 1980-01-21 |
| K800017 | COLOR CODED PUTTY SOFT, REGULAR & FIRM | Fred Sammons, Inc. | ION | Class I | 1980-01-21 |
| K800007 | WORK SIMULATOR | Baltimore Therapeutic Equipment Co. | BXB | Class I | 1980-01-21 |
| K791976 | DYNASOUND 601 | Dynawave, Corp. | IMI | Class II | 1980-01-09 |
| K792591 | STRESS TABLE/ERGOMETER SYSTEM | Victoreen, Inc. | ISD | Class II | 1980-01-04 |
| K792590 | AP-1 AUTO PROGRAMMER | Burdick Corp. | IOL | Class I | 1980-01-04 |
| K792247 | TAYLOR PATIENT TRANSFER BOARD | Taylor Medical Equipment | IKX | Class I | 1979-11-30 |
| K792241 | PELIMIT | Colmed, Ltd. | IRN | Class II | 1979-11-30 |
| K792120 | AEROBITRON II | Stanford Scientific, Inc. | ISD | Class II | 1979-11-15 |
| K792182 | ICE CONTAINER I.C.E. | Delta Medical Industries | IME | Class I | 1979-11-15 |
| K792121 | AEROBITRON III | Stanford Scientific, Inc. | ISD | Class II | 1979-11-15 |
| K792064 | DELTA ROLLING SELF-LICKING WALKER | Staricat, Inc. | ITJ | Class I | 1979-10-30 |
| K791684 | WARM-EE HEAT PACK | U.S. Export Marketing Group, Inc. | IME | Class I | 1979-10-30 |
| K791966 | AEROBITRON 1 | Stanford Scientific, Inc. | ISD | Class II | 1979-10-17 |
| K791087 | PORTABLE PULSE GALVANIC STIMULATOR | Staodynamics, Inc. | IPF | Class II | 1979-10-12 |
| K791154 | THERMAL CONDITIONING SYSTEM | Acurex Aerotherm | IRT | Class II | 1979-10-09 |
| K791866 | STANDARD HEALTH BIKE MODEL 019 | Battle Creek Equipment Co. | ISD | Class II | 1979-10-04 |
| K791931 | PREHENSILE HAND | Therapeutic Recreation Systems, Inc. | IRA | Class I | 1979-10-04 |
| K791718 | SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL | Universal-Kundle Corp. | ILJ | Class II | 1979-10-04 |
| K791808 | CERVI-TRAC | Dr. K.G. Rude | ILZ | Class I | 1979-10-01 |
| K791831 | PROCAST | Medical Specialties, Inc. | ITG | Class I | 1979-09-24 |
| K791653 | REUSABLE MOIST HEAT PACK | Tru-Eze Mfg. Co., Inc. | IMA | Class I | 1979-09-07 |
| K790993 | INSTANT HOT & COLD PACKS | Chase Mfg. Co. | IMD | Class I | 1979-09-07 |
| K791603 | GILLETTE CORDLESS WHIRLPOOL | The Gillette Company | ILJ | Class II | 1979-09-07 |
| K791162 | GELSKIN | Spenco Medical Corp. | ILO | Class II | 1979-09-04 |
| K791675 | KWICK KOOLER | Stahlex Corp. | IMD | Class I | 1979-09-04 |
| K791565 | PARAPODIUM | Physico-Medical Systems Corp. | IQI | Class I | 1979-08-28 |
| K790949 | GALVANIC UNIT | Rami International Corp. | ISB | Class II | 1979-08-16 |
| K791235 | CADWELL 7000 ELECTROMYOGRAPH MACHINE | Cadwell Laboratories, Inc. | IKN | Class II | 1979-08-16 |
| K791423 | TOILET TRAINER FOR HANDICAPPED CHILD | Kaye Products, Inc. | ILS | Class I | 1979-08-10 |
| K791408 | MAINSTREAM ELEVATING WHEEL CHAIR | Summit Services, Inc. | ITI | Class II | 1979-08-10 |
| K791350 | POPE AMBULATORY HALO VEST | Hospital Products Co. | IQF | Class I | 1979-08-03 |
| K791331 | THE TUCKER-SACH FOOT AND TUCKER-SYME FT | Kiswood Manufacturing, Inc. | ISH | Class I | 1979-08-03 |
| K791314 | VERTEBRACE SPINAL SUPPORTS | Vertebrace, Inc. | IPY | Class I | 1979-07-30 |
| K791305 | FELTLOC CAST PADDING | Howmedica Corp. | ITG | Class I | 1979-07-30 |
| K791094 | 3M ORTHOPEDIC CASTING TAPE | 3M Company | ITG | Class I | 1979-07-24 |
| K791249 | SECUTEX WRIST BRACE | Conphar, Inc. | IQI | Class I | 1979-07-24 |
| K791248 | SECUTE ELBOW BAND | Conphar, Inc. | IQI | Class I | 1979-07-24 |
| K791267 | SECUTEX ANKLE BAND | Conphar, Inc. | IQI | Class I | 1979-07-24 |
| K791266 | SECUTEX KNEE BAND | Conphar, Inc. | IQI | Class I | 1979-07-24 |
| K791048 | STIMTECH NEUROMUSCULAR STIMULATOR, C 600 | Stimulation Technology, Inc. | IPF | Class II | 1979-07-03 |
| K791057 | CAST BRACE COMPONENTS | 3M Company | IQI | Class I | 1979-06-20 |
| K790847 | EGS MODEL 300 | Alfred V. Greco | IPF | Class II | 1979-05-25 |
| K790904 | STAO-HOTPACK | Staodynamics, Inc. | IMA | Class I | 1979-05-18 |
| K790320 | DELTA-LITE | Johnson & Johnson Professionals, Inc. | ITG | Class I | 1979-05-18 |
| K790859 | PERMOBIL SUPERIOR | Saab-Scania of America, Inc. | ITI | Class II | 1979-05-15 |
| K790858 | PERMOBIL EXTERIOR | Saab-Scania of America, Inc. | ITI | Class II | 1979-05-15 |
| K790120 | SLENDERTONE | Bloomex International, Inc. | IPF | Class II | 1979-05-07 |
| K790531 | ANUS STIMULATOR | Maddak, Inc. | ILS | Class I | 1979-04-26 |
| K790664 | MODEL 1309 AUDIO MONITOR | Life-Tech Instruments, Inc. | IKN | Class II | 1979-04-23 |
| K790572 | LOUNGE, TILT-A-BODY STRETCH | Innovative Products, Inc. | ION | Class I | 1979-04-10 |
| K790374 | GILLETTE HEAT WRAP | The Gillette Company | IRT | Class II | 1979-04-10 |
| K790560 | ROLLCHAIR, ORTHO BUCKET SEAT | Maddak, Inc. | INM | Class I | 1979-04-10 |
| K790652 | TOGUARD | Togard, Inc. | IPG | Class I | 1979-04-04 |
| K790528 | THERAPY GYROSCOPE | Maddak, Inc. | KNL | Class I | 1979-04-03 |
| K790529 | WALKING AID | Maddak, Inc. | ITJ | Class I | 1979-04-03 |
| K790561 | OFFSET ALUMINUM CANE | Maddak, Inc. | IPS | Class I | 1979-04-03 |
| K790587 | CANVAS WEDGE | Maddak, Inc. | IOD | Class I | 1979-04-03 |
| K790558 | CERSA-CANE | Maddak, Inc. | IPS | Class I | 1979-04-03 |
| K790557 | CRUTCH | Maddak, Inc. | IPR | Class I | 1979-04-03 |
| K790480 | TULANE HEAT-PACK | Tulane | IMD | Class I | 1979-04-03 |
| K790530 | PUSH BALL INCLINE | Maddak, Inc. | ION | Class I | 1979-04-03 |
| K790527 | BURNETT-KETCHUM DYNAMIC HAND EXERCISER | Maddak, Inc. | JFA | Class I | 1979-03-22 |
| K790183 | PORTABLE WHEELCHAIR & CARRYING CASE | Fred Sammons, Inc. | IOR | Class I | 1979-03-21 |
| K790205 | ELECTROAPPLICATOR MODEL C-1 | Mcg, Inc. | KTB | Class II | 1979-03-19 |
| K790326 | DRUSHOE | J.E. Hanger & Co. , Ltd. | KNP | Class I | 1979-02-26 |
| K790175 | SEMI-RECLINING BATH CHARI & BELT | Fred Sammons, Inc. | ILS | Class I | 1979-02-22 |
| K790173 | BK-5371 GAD-19-BOUT PERSONAL MOBIL AID | Fred Sammons, Inc. | IKW | Class I | 1979-02-22 |
| K790299 | FOREARM-CANE | Guardian Products Co., Inc. | IPS | Class I | 1979-02-21 |
| K790182 | 2 VELCRO SPLINT STRAP | Fred Sammons, Inc. | ILH | Class I | 1979-02-15 |
| K790181 | SOFT SPLINT STRAPS | Fred Sammons, Inc. | ILH | Class I | 1979-02-13 |
| K790170 | BK-1472 SPATULA SPOON | Fred Sammons, Inc. | ILC | Class I | 1979-02-13 |
| K790180 | PLATFORM SPLINTS | Fred Sammons, Inc. | ILH | Class I | 1979-02-13 |
| K790265 | LEVO-STAND-UP WHEELCHAIR | Marion Laboratories, Inc. | IPL | Class II | 1979-02-13 |
| K790033 | HVG-100 | Elmed, Inc. | IPF | Class II | 1979-02-09 |
| K790176 | ADJUSTABLE HEIGHT DESK ARM LAP TRAY KIT | Fred Sammons, Inc. | KNO | Class I | 1979-02-08 |
| K790177 | ASHTRAY FOR WHEELCHAIR | Fred Sammons, Inc. | KNO | Class I | 1979-02-08 |
| K790179 | GAIR TRAINING BELT | Fred Sammons, Inc. | ISR | Class I | 1979-02-08 |
| K790171 | BK-2084 PLASTIC SOCK AND STOCKING AID | Fred Sammons, Inc. | ILD | Class I | 1979-02-08 |
| K790178 | WATER POWERED BATH CHAIR LIFT | Fred Sammons, Inc. | ILS | Class I | 1979-02-08 |
| K790191 | VISA-GRIP | Premier Sundries, Inc. | ION | Class I | 1979-02-08 |
| K790009 | ICE PACK, REUSABLE FLEXIBLE | Ackrad Laboratories | IME | Class I | 1979-01-22 |
| K781997 | AUTORANGE | Tri W-G, Inc. | ISD | Class II | 1979-01-08 |
| K782148 | HR UNIT | Parke-Davis Co. | IQP | Class I | 1979-01-08 |
| K781964 | COMPRESSION DEVICES, LIMB | Alba-Waldensian, Inc. | IRP | Class II | 1978-12-12 |
| K781455 | SIEMENS ULTRATHERM 708 | Elmed, Inc. | IMJ | Class II | 1978-12-07 |
| K781947 | STROLLER, THERAPY | Convaid Products, Inc. | LBE | Class I | 1978-12-04 |
| K781889 | COLLINS PEDALMATE 2 | Warren E. Collins, Inc. | ISD | Class II | 1978-11-22 |
| K781700 | IONOTPHORETIC APPLICATOR | Mcghan Medical Corp. | KTB | Class II | 1978-11-03 |
| K781239 | MYO-STIM | Med General | IPF | Class II | 1978-11-03 |
| K781761 | KENDRICK EXTRICATION DEVICE | Medi-Ked, Inc. | IQF | Class I | 1978-10-27 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.