Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 36
- Latest Decision
- 1994-11-08
Clearances · page 30 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K934556 | EMS-250 | Electronic Medical Sciences, Inc. | IPF | Class II | 1994-11-08 |
| K943789 | POWER WHEELCHAIR CONVERSION KIT | Alber Technologies, Inc. | ITI | Class II | 1994-11-08 |
| K942311 | DYNASTY U1-33 AGM | Foley & Lardner | KNN | Class I | 1994-11-07 |
| K942310 | DYNASTY GC 12550 (GELL/CELL) | Foley & Lardner | KNN | Class I | 1994-11-07 |
| K944939 | CELEBRITY XL SC445 | Pride Health Care, Inc. | INI | Class II | 1994-11-07 |
| K942309 | DYNASTY U1-31 (GELL/CELL) | Foley & Lardner | KNN | Class I | 1994-11-07 |
| K942308 | DYNASTY GC 12400 (GELL/CELL) | Foley & Lardner | KNN | Class I | 1994-11-07 |
| K942508 | ROBO | Permobil AB | INI | Class II | 1994-11-07 |
| K934238 | MULE | Penny and Giles Biometrics , Ltd. | ISD | Class II | 1994-10-26 |
| K944574 | LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI) | Lumex, Inc. | IOR | Class I | 1994-10-17 |
| K944345 | BEDSIDE BUTLER | Trac Medical, Inc. | IQA | Class II | 1994-10-17 |
| K925195 | MALIBU BATHING SYSTEM | Medi-Man Rehabilitation Products, Inc. | ILJ | Class II | 1994-10-17 |
| K943972 | EURO TECH DIAMOND CHIROPRACTIC TABLE | Progressive Electrical Therapeutics | INQ | Class I | 1994-10-11 |
| K943035 | P.A.T. SYSTEM | Mathews Assoc., Inc. | ILQ | Class II | 1994-10-04 |
| K932059 | NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE | Dantec Medical, Inc. | IKT | Class II | 1994-10-04 |
| K924970 | FEMININE HEAT WRAP | Conair Corp. | IRT | Class II | 1994-10-03 |
| K933964 | THE CRADLE | The Primal Energy Research Foundation | IKZ | Class II | 1994-10-03 |
| K935509 | HYDROTRACK | Ferno Ille | BXB | Class I | 1994-10-03 |
| K943975 | EURO TECH PLATINUM CHIROPRACTIC TABLE | Progressive Electrical Therapeutics | INW | Class I | 1994-09-29 |
| K943092 | FAMILY FITNESS SHIATSU MASSAGER | Conair Corp. | ISA | Class I | 1994-09-29 |
| K940132 | PODIATRIC MATERIAL | Crown Delta Corp. | MNE | Class I | 1994-09-29 |
| K943974 | EURO TECH MARQUISE CHIROPRACTIC TABLE | Progressive Electrical Therapeutics | INW | Class I | 1994-09-29 |
| K930735 | LORDEX LUMBAR EXTENSION MACHINE | Lordex, Inc. | ISD | Class II | 1994-09-29 |
| K943973 | EURO TECH STERLING ROLLER TABLE | Progressive Electrical Therapeutics | JFB | Class II | 1994-09-29 |
| K943936 | XLT, REA COMFORT, SPIREA, ZOOM | Electric Mobility Corp. | IOR | Class I | 1994-09-21 |
| K942059 | KT2000 KNEE LIGAMENT ARTHROMETER | Medmetric Corp. | LYH | Class I | 1994-09-20 |
| K935061 | LOWER BODY CYCLES | Biodex Medical Systems, Inc. | BXB | Class I | 1994-09-16 |
| K935216 | SEMI-RECUMBENT CYCLES | Biodex Medical Systems, Inc. | BXB | Class I | 1994-09-16 |
| K935520 | UPPER BODY CYCLES (110 VOLT)/(220 VOLT) | Biodex Medical Systems, Inc. | BXB | Class I | 1994-09-16 |
| K944122 | DAB WELDLESS WHEELCHAIR | Da Intl. , Ltd. | IOR | Class I | 1994-09-13 |
| K943469 | SONICATOR 730 | Mettler Electronics Corp. | IMG | Class II | 1994-08-29 |
| K935841 | DR KOOL | Toronto Medical Corp. | ILO | Class II | 1994-08-29 |
| K925193 | AQUACISER II | Aquaciser, Inc. | ILJ | Class II | 1994-08-26 |
| K931029 | DISPOSABLE CONCENTRIC NEEDLE ELECTRODE | Chalgren Enterprises, Inc. | IKT | Class II | 1994-08-25 |
| K943330 | ACTION-LIFT CHAIR | Alc, Inc. | INO | Class II | 1994-08-24 |
| K943293 | SCC22/ SCC26 SHOWER COMMODE CHAIR | O'Tec Corp. | IOR | Class I | 1994-08-19 |
| K943337 | STANDUP WHEELCHAIR | Nestor Rehab Products , Ltd. | IPL | Class II | 1994-08-09 |
| K932620 | RH-806/GS MODEL TRANSQ(R)2 | Iomed, Inc. | EGJ | Class II | 1994-07-26 |
| K932621 | RH-801/GS MODEL TRANSQ(R)1 | Iomed, Inc. | EGJ | Class II | 1994-07-26 |
| K934335 | PHORESOR II AUTO, MODEL PM800 MODIFICATION | Iomed, Inc. | EGJ | Class II | 1994-07-26 |
| K942950 | BODY FLEX | Conair Corp. | ISA | Class I | 1994-07-26 |
| K913601 | MICROPHOR | Life-Tech Intl., Inc. | EGJ | Class II | 1994-07-15 |
| K915444 | DUPEL IONTOPHORESIS DEVICE | Empi | EGJ | Class II | 1994-07-15 |
| K925806 | RH-801, MODEL TRANSQ | Iomed, Inc. | EGJ | Class II | 1994-07-14 |
| K925800 | RH-806, MODEL TRANSQ | Iomed, Inc. | EGJ | Class II | 1994-07-14 |
| K930044 | COMFORT KEYBOARD SYSTEM | Health Care Keyboard Co., Inc. | ILQ | Class II | 1994-07-14 |
| K933194 | THE SIGNATURE SERIES, IMC IV | Progressive Electrical Therapeutics | IPF | Class II | 1994-07-13 |
| K930613 | HOOKING SYSTEM | Alain Machtelinckx | LYG | Class I | 1994-07-12 |
| K940429 | ORTHO TECH CRYOLOGIC SYSTEM | Orthopedic Technology, Inc. | ILO | Class II | 1994-07-12 |
| K933196 | THE SIGNATURE SERIES, IC II | Progressive Electrical Therapeutics | IPF | Class II | 1994-07-12 |
| K940858 | THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) | Innovation Sports, Inc. | ILO | Class II | 1994-07-12 |
| K936143 | ISOCOMFORTER | Isocomforter, Inc. | ILO | Class II | 1994-07-12 |
| K930624 | SANITAS WHIRPOOL BATHING SYSTEM | Dutton-Lainson Co. | ILJ | Class II | 1994-07-01 |
| K930096 | NO CROSS CONTAM HYDROTHERAPY TANK LINER | Land and Sky Mfg., Inc. | ILJ | Class II | 1994-06-30 |
| K940621 | PRO-SHIATSU PORTABLE MASSAGER | Westminster International Co., Inc. | ISA | Class I | 1994-06-22 |
| K942218 | SHIATSU MASSAGER | Westminster International Co., Inc. | ISA | Class I | 1994-06-22 |
| K933059 | ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. | Jace Systems, Inc. | BXB | Class I | 1994-06-22 |
| K942618 | ANKLE CALF EXERCISER | Prevent Products, Inc. | BXB | Class I | 1994-06-22 |
| K942397 | THERADAPT HIGHCHAIR/STROLLER INSERT | Theradapt Products, Inc. | INN | Class I | 1994-06-22 |
| K931016 | JACE MODEL H440 HAND CPM DEVICE | Jace Systems, Inc. | JFA | Class I | 1994-06-22 |
| K941561 | FORTE US | Chattanooga Group, Inc. | IMG | Class II | 1994-06-20 |
| K933611 | THE BTE WS30 | Baltimore Therapeutic Equipment Co. | ISD | Class II | 1994-06-20 |
| K942075 | VECTOR POWER WHEELCHAIR | Vector Mobility, Inc. | ITI | Class II | 1994-06-15 |
| K940662 | I-5000 | Support Systems Intl. | IOQ | Class II | 1994-06-15 |
| K941976 | WHEELCHAIR,MECHANICAL | Tone World International | IOR | Class I | 1994-06-13 |
| K941642 | ASCENDA | American Stair-Glide Corp. | ING | Class II | 1994-06-13 |
| K934886 | NEXT WAVE PHYSIOACOUSTIC MATTRESS | Next Wave, Inc. | IRO | Class I | 1994-06-09 |
| K941594 | WAHL DOUBLE COMFORT MASSAGER | Wahl Clipper Corp. | ISA | Class I | 1994-06-09 |
| K942223 | BODY SYSTEM | Conair Corp. | ISA | Class I | 1994-06-09 |
| K940837 | WAHL(R) FOOT COMFORT MASSAGER | Wahl Clipper Corp. | IRO | Class I | 1994-06-09 |
| K922456 | K6-I DIAGNOSTIC SYSTEM | Myo-Tronics, Inc. | KZM | Class II | 1994-06-09 |
| K940683 | WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA | Wahl Clipper Corp. | ISA | Class I | 1994-06-09 |
| K941412 | WAHL COMPACT COMFORT MASSAGER | Wahl Clipper Corp. | IRO | Class I | 1994-06-09 |
| K935995 | HAND-HELD HEAT APPLICATOR | Avon Products, Inc. | ILY | Class II | 1994-06-09 |
| K940200 | EXCEL TX | Excel Tech. , Ltd. | ITH | Class II | 1994-06-07 |
| K940972 | MODEL MCC - MKIV MICRO COMPUTER CONTROLS | Invacare Corp. | ITI | Class II | 1994-06-02 |
| K940160 | TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM | Burke Neutech, Inc. | ILO | Class II | 1994-05-27 |
| K942312 | ALDEN LINEAGE WHEELCHAIR CUSHION | Lewis W. Ward | KNN | Class I | 1994-05-26 |
| K942260 | ALDEN WHEELCHAIR CUSHION | Ward and Assoc. | KNN | Class I | 1994-05-26 |
| K930918 | HYDROT | Sanker Intl., Inc. | ILO | Class II | 1994-05-25 |
| K926136 | WATSYSTEM | Watsystem Div. of Itc | BXB | Class I | 1994-05-20 |
| K941049 | MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR | Smith & Nephew, Inc. | IPF | Class II | 1994-05-19 |
| K940334 | AMIGO J-9 | Amigo Mobility Intl., Inc. | INI | Class II | 1994-05-18 |
| K941989 | ACTION AT MANUAL WHEELCHAIR | Nvacare Corp. | IOR | Class I | 1994-05-11 |
| K931855 | LIGHTWRITER | Zygo Corp. | ILQ | Class II | 1994-05-10 |
| K941738 | STRYKER 5050 STRECHAIR | Stryker Medical | INM | Class I | 1994-05-06 |
| K941966 | CAT SCOOTER | Genus Medical, Inc. | INI | Class II | 1994-05-06 |
| K935201 | QUADTRAX | Body Bike, Inc. | ITI | Class II | 1994-05-06 |
| K931128 | BASIC SHOULDER CPM | Danninger Medical Technology, Inc. | BXB | Class I | 1994-05-06 |
| K941281 | OCCUPATIONAL THERAPY TABLES | Med Mart, Inc. | INQ | Class I | 1994-05-06 |
| K941720 | MODEL 747 AND 747-30 EXAM/TREATMENT TABLE | Tri W-G, Inc. | INQ | Class I | 1994-05-06 |
| K931231 | SIDEKICK II | Pride Health Care, Inc. | INI | Class II | 1994-05-05 |
| K926279 | UPPER BODY EXERCISER | Henley Intl. | ISD | Class II | 1994-05-05 |
| K941858 | GEL CUSHION | Hollister, Inc. | KIC | Class I | 1994-05-05 |
| K926278 | STAIR CLIMBER | Henley Intl. | ISD | Class II | 1994-05-05 |
| K941301 | ROLL A BOUT WALKER | Roll A Bout Corp. | IOR | Class I | 1994-05-02 |
| K941245 | POLY-MEDICS HEAT PACK | Biomet, Inc. | IMD | Class I | 1994-05-02 |
| K940223 | LEARN MODE WATERPROOF PENDANT PANIC BUTTON | Interactive Technologies, Inc. | IQA | Class II | 1994-04-29 |
| K933418 | HAND THERAPY ASSOST | Bardon Ent., Inc. | JFA | Class I | 1994-04-28 |
| K935728 | DYNATRON 150 | Dynatronics Corp. | IMG | Class II | 1994-04-26 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.