Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 24
- Latest Decision
- 1994-04-26
Clearances · page 31 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K941569 | CAREMOR CLINER | Winco, Inc. | INM | Class I | 1994-04-26 |
| K936148 | STRESS HANDLER | Arocep Enterprises , Ltd. | LYG | Class I | 1994-04-21 |
| K940369 | BODY RECHARGER | Conair Corp. | ISA | Class I | 1994-04-21 |
| K940543 | MODEL 777 THERAPEUTIC MASSAGER | Voyager Medical Corp. | ISA | Class I | 1994-04-21 |
| K935467 | R & D BATTERIES, INC. PART NUMBER 5447 | R & D Batteries, Inc. | BXB | Class I | 1994-04-19 |
| K935244 | R & D BATTERIES, INC. PART NUMBER 5113 | R & D Batteries, Inc. | ILQ | Class II | 1994-04-19 |
| K941088 | STRYKER BACK-SAVER STRETCHER CHAIR MODEL 6320 | Stryker Corp. | IOR | Class I | 1994-04-15 |
| K940590 | MINTO SKIN TRACTION MOTOR | Minto Research & Development, Inc. | ITH | Class II | 1994-04-15 |
| K940180 | FORTE US | Chattanooga Group, Inc. | IMG | Class II | 1994-04-15 |
| K941157 | BASIC RECLINE CHAIR | Labac Systems, Inc. | IOR | Class I | 1994-04-07 |
| K941236 | VECTOR WHEELCHAIR | Vector Mobility, Inc. | IOR | Class I | 1994-04-06 |
| K934919 | THE SIGNATURE SERIES, MAGNUM 100 | Progressive Electrical Therapeutics | IPF | Class II | 1994-04-06 |
| K934287 | DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR | Dynawave, Corp. | IMG | Class II | 1994-04-04 |
| K932240 | MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS | Bailey Mfg. Co. | IRR | Class I | 1994-04-01 |
| K940349 | NEUROMUSCULAR ELECTRICAL STIMULATOR | Progressive Concepts, Inc. | IPF | Class II | 1994-04-01 |
| K930742 | PEGASUS PROACTIVE WHEELCHAIR CUSHION | Pegasus Airwave, Inc. | ITI | Class II | 1994-03-31 |
| K936084 | OMNI WARM GEL PACKS | Omni Therm, Inc. | IMD | Class I | 1994-03-31 |
| K931261 | SPECTROPAD SYSTEM | Smi | ILY | Class II | 1994-03-31 |
| K925907 | AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER | Pollenex Corp. | ISA | Class I | 1994-03-30 |
| K933662 | MERITS WHEELCHAIR | Merits Health Products., Inc. | ITI | Class II | 1994-03-30 |
| K931966 | DANTEC DISPOSABLE CONCENTRIC NEEDLE | Dantec Medical, Inc. | IKT | Class II | 1994-03-30 |
| K925122 | PACE SAVER LITTLE JR | Burke Mobility Products | INI | Class II | 1994-03-30 |
| K925724 | M100 POWERED WHEELCHAIR | Mcnally Industries, Inc. | ITI | Class II | 1994-03-29 |
| K934232 | COMMUTER (MANUAL/POWER WHEELCLHAIR) | Fortress Lite-Style Wheelchairs, Inc. | ITI | Class II | 1994-03-29 |
| K925865 | KID POWER | Everest & Jennings, Inc. | ITI | Class II | 1994-03-28 |
| K933861 | S860 SEATING SYSTEM | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K932786 | UCS 1000(TM) WITH TONGUETOUCH KEYPAD WHEELCHAIR | New Abilities Systems, Inc. | ITI | Class II | 1994-03-28 |
| K933864 | 720 POWER BASE | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K940051 | ACTION STORM POWER WHEELCHAIR | Invacare Corp. | ITI | Class II | 1994-03-28 |
| K924278 | QUICKIE P200 | Quickie Designs, Inc. | ITI | Class II | 1994-03-28 |
| K932329 | HOVEROUND POWER CHAIR | Hoveround Corp. | ITI | Class II | 1994-03-28 |
| K935410 | HOVEROUND MPV | Hoveround Corp. | ITI | Class II | 1994-03-28 |
| K926296 | CELEBRITY SC400 | Pride Health Care, Inc. | INI | Class II | 1994-03-28 |
| K935317 | ALPHA TALKER | Prentke Romich Co. | ITI | Class II | 1994-03-28 |
| K933856 | A921 12 VOLT POWER SOCKET | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K924515 | ELECTRIC MOBILITY RASCAL | Electric Mobility, LLC | INI | Class II | 1994-03-28 |
| K933859 | SC930 SEAT CONTROLLER | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K931638 | FO96 HANDY MASSAGER | Fairform Mfg., Co., Ltd. | IRO | Class I | 1994-03-28 |
| K933863 | S500 SEATING SYSTEM | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K933853 | A901 TILT IN SPACE | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K933855 | S490 SEATING SYSTEM | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K931640 | AO11 BODY MASSAGER | Fairform Mfg., Co., Ltd. | IRO | Class I | 1994-03-28 |
| K933860 | S480 SEATING SYSTEM | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K930952 | PRIDE LEGEND SC-340 | Pride Health Care, Inc. | INI | Class II | 1994-03-28 |
| K930088 | FORTRESS C-500 MICROPROCESSOR CONTROLLER | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K932597 | FORTRESS C-300 MICROPROCESSOR CONTROLLER | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K926295 | LEGEND SC 300 | Pride Health Care, Inc. | INI | Class II | 1994-03-28 |
| K926499 | SHUTTLE SC-140 | Pride Health Care, Inc. | INI | Class II | 1994-03-28 |
| K931639 | F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR | Fairform Mfg., Co., Ltd. | IRO | Class I | 1994-03-28 |
| K933207 | WALKERTALKER | Prentke Romich Co. | ITI | Class II | 1994-03-28 |
| K931637 | A013 FEMI-FORM FACIAL MASSAGER | Fairform Mfg., Co., Ltd. | IRO | Class I | 1994-03-28 |
| K931636 | FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER | Fairform Mfg., Co., Ltd. | ISA | Class I | 1994-03-28 |
| K933854 | 770 POWER BASE | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K930953 | CELEBRITY SC440 | Pride Health Care, Inc. | INI | Class II | 1994-03-28 |
| K933858 | 730 POWER BASE | Fortress Scientific , Ltd. | ITI | Class II | 1994-03-28 |
| K930676 | ACTION TIGER POWERED WHEELCHAIR | Invacare Corp. | ITI | Class II | 1994-03-25 |
| K930803 | ACTION PATRIOT MANUAL WHEELCHAIR | Invacare Corp. | IOR | Class I | 1994-03-24 |
| K935188 | STRETCHPOWER | Orthopedic Development, Inc. | BXB | Class I | 1994-03-24 |
| K934175 | STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER | Orthopedic Development, Inc. | BXB | Class I | 1994-03-24 |
| K931401 | EMS | Saratoga Intl., Inc. | IPF | Class II | 1994-03-23 |
| K934846 | SONICATOR 716 | Mettler Electronics Corp. | IMG | Class II | 1994-03-23 |
| K933653 | MS 2500 | Lsi Intl., Inc. | IPF | Class II | 1994-03-23 |
| K926287 | EXERCISE BICYCLE | Henley Intl. | ISD | Class II | 1994-03-22 |
| K936303 | TREATMENT TABLE MODIFICATION | Tri W-G, Inc. | INQ | Class I | 1994-03-18 |
| K935808 | REVOLUTION LOWER LIMB CPM UNIT | Toronto Medical, Inc. | BXB | Class I | 1994-03-18 |
| K926314 | HYDRA FITNESS MODEL 311 TOTAL POWER | Henley Intl. | ISD | Class II | 1994-03-18 |
| K934236 | LEGEND (MANUAL WHEELCHAIR) | Fortress Lite-Style Wheelchairs, Inc. | IOR | Class I | 1994-03-17 |
| K934234 | VISION (MANUAL WHEELCHAIR) | Fortress Lite-Style Wheelchairs, Inc. | IOR | Class I | 1994-03-17 |
| K932898 | POWERED MUSCLE STIMULATOR | Nemectron GmbH | IPF | Class II | 1994-03-15 |
| K926084 | HVGS 9000 | Shevlin Medical, Inc. | IPF | Class II | 1994-03-14 |
| K933394 | DANNIFLEX CPM 600 | Danninger Medical Technology, Inc. | BXB | Class I | 1994-03-11 |
| K940336 | CERTI HEAT INSTANT HEAT COMPRESS | Certified Safety Mfg., Inc. | IMD | Class I | 1994-03-07 |
| K935569 | INSTANT HOT OR COLD DISPOSABLE PACK | Cryopak Industries, Inc. | IMD | Class I | 1994-03-07 |
| K940238 | TUMBLE FORMS JUNIOR TRISTANDER | Camp Intl., Inc. | INW | Class I | 1994-03-07 |
| K935581 | OMRON MASSAGER MODEL HM-102 | Omron Healthcare, Inc. | ISA | Class I | 1994-03-04 |
| K935462 | OMBRON TWIN-HEAD MASSAGER MODEL HM-101 | Omron Healthcare, Inc. | ISA | Class I | 1994-03-04 |
| K935459 | OMRON MASSAGER MODEL HM-45 | Omron Healthcare, Inc. | ISA | Class I | 1994-03-04 |
| K926339 | BODY RELAXER | Conair Corp. | ISA | Class I | 1994-03-04 |
| K935398 | TRACER SERIES MANUAL WHEELCHAIRS | Invacare Corp. | IOR | Class I | 1994-03-01 |
| K940131 | TABLE MAT MORTORIZED/ELECTRIC | Med Mart, Inc. | INQ | Class I | 1994-02-25 |
| K925630 | ELASTOPLAST HEAT PLASTER | Beiersdorf, Inc. | IRT | Class II | 1994-02-25 |
| K911727 | INFRADERM; TOUCH 'N TONE PLUS | Conair Corp. | ISA | Class I | 1994-02-25 |
| K933195 | THE SIGNATURE SERIES, IC IV | Progressive Electrical Therapeutics | IPF | Class II | 1994-02-23 |
| K931203 | COOL-AID | Seabrook Medical Systems, Inc. | ILO | Class II | 1994-02-22 |
| K932538 | CABOT MEDICAL IRRIGATION FLUID WARMER SETS | Cabot Medical Corp. | LHC | Class I | 1994-02-22 |
| K934553 | WHEEL-O-VATOR | The National Wheel-O-Vator Co., Inc. | ING | Class II | 1994-02-17 |
| K940304 | NITRO | Everest & Jennings, Inc. | IOR | Class I | 1994-02-17 |
| K940303 | RECORD | Everest & Jennings, Inc. | IOR | Class I | 1994-02-17 |
| K935981 | MLT-2 | Med Labs, Inc. | ILQ | Class II | 1994-02-17 |
| K932904 | WINDMERE WAND MASSAGER | Windmere Corp. | ISA | Class I | 1994-02-17 |
| K931168 | X-20 AIR SUPPORT BED | American Life Support Technology, Inc. | INX | Class II | 1994-02-17 |
| K930780 | ADV400 TOE CPM | Advanced Kinetics, Inc. | BXB | Class I | 1994-02-17 |
| K933727 | POWERMATIC EXAMINATION TABLE | Hausmann Industries, Inc. | INQ | Class I | 1994-02-09 |
| K926313 | COMPUTERIZED TESTING AND EXERCISE SYSTEMS | Henley Intl. | BXB | Class I | 1994-02-04 |
| K934631 | TRANSWARMER | Prism Technologies, Inc. | IMD | Class I | 1994-02-03 |
| K935271 | THERAPEUTIC ULTRASOUND AND STIMULATOR | Chattanooga Group, Inc. | IMG | Class II | 1994-02-02 |
| K923238 | SONASSAGE | Conair Corp. | IRO | Class I | 1994-02-02 |
| K933974 | WINDMERE MASSAGE MATE | Windmere Corp. | IRO | Class I | 1994-02-02 |
| K934673 | KACEY DISPOSABLE INFANT HEEL WARMER | K & C Medical, Inc. | IMD | Class I | 1994-02-02 |
| K930692 | LATHAM TABLE | I-Rep, Inc. | INQ | Class I | 1994-02-02 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.