Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 38
- Latest Decision
- 1993-06-24
Clearances · page 33 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K923541 | BODY-MATE MASSAGER | American Therapy Products | ISA | Class I | 1993-06-24 |
| K925652 | UNIVERSAL WHEELCHAIR LIFT | Better Life Medical Technologies, Inc. | INO | Class II | 1993-06-24 |
| K925839 | TRACKMASTER | Jas Manufacturing Co., Inc. | IOL | Class I | 1993-06-24 |
| K926189 | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE | Bio Clinic Co. | IOQ | Class II | 1993-06-24 |
| K930089 | SMS BALANCE PERFORMANCE MONITOR | Sms Technologies, Ltd. | KHX | Class I | 1993-06-08 |
| K923033 | THE TRACKER | Epm Information Systems, Inc. | LXJ | Class II | 1993-06-01 |
| K926137 | ANAGO FEM-COOL/FEM-COOL PETITE | Anago, Inc. | IMD | Class I | 1993-05-26 |
| K925563 | FT MODEL TABLE W/ELECTRIC HI LO OPTION E | Pro Med Mfg., Inc. | INQ | Class I | 1993-05-26 |
| K926590 | ANAGO DISPOSABLE INSTANT COLD PACK | Anago, Inc. | IMD | Class I | 1993-05-26 |
| K923396 | THERMODYN | Nemectron Medical, Inc. | IRT | Class II | 1993-05-26 |
| K926589 | ANAGO WARM PACK | Anago, Inc. | IMD | Class I | 1993-05-26 |
| K924293 | HERITAGE 10 | Tjn Manufacturing,Inc. | JFB | Class II | 1993-05-26 |
| K930261 | RTM REHABILITATION TREADMILL, MODEL #945-200 | Biodan Medical Systems, Ltd. | IOL | Class I | 1993-05-26 |
| K926151 | LSI6000 THERMAL THERAPY SYSTEM | Burke Neutech, Inc. | ILO | Class II | 1993-05-26 |
| K924512 | LIDO V-TAK | Loredan Biomedical, Inc. | LXJ | Class II | 1993-05-12 |
| K924705 | FORCE SENSING ARRAY | Force Sensing Systems | JFC | Class I | 1993-05-12 |
| K924699 | PMP MUSCLE STIMULATOR | Preferred Medical Products | IPF | Class II | 1993-04-30 |
| K921436 | SONICATOR PLUS | Mettler Electronics Corp. | IMG | Class II | 1993-04-27 |
| K925677 | AUTOCHILL ACCESSORY KIT | Aircast, Inc. | ILO | Class II | 1993-04-14 |
| K923627 | COLD PACK | Friendmed Products | IME | Class I | 1993-04-14 |
| K924023 | FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 | Ferno | IRQ | Class I | 1993-04-14 |
| K930411 | UNIVERSAL WHEELCHAIR | Everest & Jennings, Inc. | IOR | Class I | 1993-03-31 |
| K925977 | PARAMED FLEXION-EXTENSION MACHINE | Paramed Services, Inc. | BXB | Class I | 1993-03-31 |
| K926170 | STEPMILL EXERCISE SYSTEM | Stairmaster Sports/Medical Products, Inc. | ISD | Class II | 1993-03-31 |
| K925271 | REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE | Repex Intl., Inc. | BXB | Class I | 1993-03-31 |
| K930413 | PREMIER CLASSIC | Everest & Jennings, Inc. | IOR | Class I | 1993-03-31 |
| K921000 | SONACARE SOUND MASSAGER | Honor Trading, Ltd. | ISA | Class I | 1993-03-31 |
| K930412 | PREMIER 2 WHEELCHAIR | Everest & Jennings, Inc. | IOR | Class I | 1993-03-31 |
| K924513 | LIDO(R) LINEA | Loredan Biomedical, Inc. | BXB | Class I | 1993-03-31 |
| K923643 | MEDICOOL | Micromedic Systems | ILO | Class II | 1993-03-31 |
| K926291 | SCHUL-TEC IMMOBILIZER | Medical Emergency Support Equipment | IQK | Class I | 1993-03-30 |
| K930262 | TREATMENT TABLE, MODEL #825-100 | Biodan Medical Systems, Ltd. | INO | Class II | 1993-03-29 |
| K925387 | LIBERATOR | Prentke Romich Co. | ILQ | Class II | 1993-03-29 |
| K923362 | REDUCED SHEAR OWR RECLINE SYSTEM | Labac Systems, Inc. | ITI | Class II | 1993-03-26 |
| K926029 | INFRA-LINK | Zygo Industries, Inc. | IQA | Class II | 1993-03-26 |
| K926316 | TRUE-TRAC, STRATUS | Henley Intl. | JFB | Class II | 1993-03-24 |
| K926026 | DESKS | Theradapt Products, Inc. | INW | Class I | 1993-03-24 |
| K923942 | RHOMBO MEDICAL RHOMBO-FILL | International Medical Products, Inc. | KNN | Class I | 1993-03-24 |
| K925807 | AQUACISER IN-POOL TREADMILL | Aquaciser, Inc. | BXB | Class I | 1993-03-24 |
| K923365 | TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM | Labsystems, Inc. | ITI | Class II | 1993-03-24 |
| K926402 | COMFORT CARE LOW AIR LOSS THERAPY BED | Ch Administration, Inc. | INX | Class II | 1993-03-24 |
| K921028 | MANUAL RECLINING CHAIR | Labac Systems, Inc. | IOR | Class I | 1993-03-24 |
| K925164 | ELECTRIC STAND-IN TABLE | Midland Mfg. Co. | INQ | Class I | 1993-03-24 |
| K930259 | TRACTION TABLE MODEL #825-200 | Biodan Medical Systems, Ltd. | JFB | Class II | 1993-03-24 |
| K925980 | PM | Pathfinder Intl. Corp. | KNN | Class I | 1993-03-24 |
| K926456 | MICROAIR TURN-Q | Gsi Development Co. | IOQ | Class II | 1993-03-24 |
| K926028 | BENCHES | Theradapt Products, Inc. | INM | Class I | 1993-03-24 |
| K925451 | SHADOW RIGID WHEELCHAIR | Magic-In-Motion, Inc. | IOR | Class I | 1993-03-24 |
| K930520 | THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR | Theradapt Products, Inc. | INN | Class I | 1993-03-24 |
| K923363 | ADJUSTABLE SLIDING BACK POWER RECLINE SYSTEM | Labac Systems, Inc. | ITI | Class II | 1993-03-24 |
| K925694 | MICROAIR PUP | Gsi Medical Systems | IOQ | Class II | 1993-03-24 |
| K925527 | LIGHT TALKER | Prentke Romich Co. | ILQ | Class II | 1993-03-22 |
| K926025 | CHAIRS | Theradapt Products, Inc. | INM | Class I | 1993-03-22 |
| K915369 | THE EQUALIZER | Advanced Rehabilitative Technology, Inc. | IKE | Class I | 1993-03-22 |
| K930802 | MODELS 642 & 643 TILT EXAM/TREATMENT TABLE | Tri W-G, Inc. | INQ | Class I | 1993-03-22 |
| K924484 | ARTROMOT MULTI DIRECTIONAL ANKLE CPM | Buckman Co., Inc. | BXB | Class I | 1993-03-22 |
| K923364 | TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST | Labac Systems, Inc. | KNN | Class I | 1993-03-22 |
| K926054 | ELD-ARONDAK CHAIR | Al'S Woodcraft, Inc. | INM | Class I | 1993-03-22 |
| K926053 | ELD-ARONDAK CHAIR | Alert Care, Inc. | INM | Class I | 1993-03-22 |
| K923710 | OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED | Progressive Medical Technology, Inc. | IKZ | Class II | 1993-03-22 |
| K925926 | MOBILIMB T1 TOE CPM UNIT | Toronto Medical Corp. | BXB | Class I | 1993-03-22 |
| K920983 | SONOPULS 590 | Henley Intl. | IMI | Class II | 1993-03-09 |
| K925666 | THERAPACER 3000 | Kvm Technologies, Inc. | BXB | Class I | 1993-03-09 |
| K925258 | DYNAMIC PRESSURE MONITOR 2000M AND 2000C | Pin Dot Products, Inc. | JFC | Class I | 1993-03-09 |
| K921952 | ULTRA III | Excel Tech. , Ltd. | IMG | Class II | 1993-03-09 |
| K923076 | ULTRA SX | Excel Tech. , Ltd. | IMI | Class II | 1993-03-09 |
| K925052 | QA PRESSURE MEASUREMENT SYSTEM | Gabel Medical Instruments, Ltd. | JFC | Class I | 1993-03-09 |
| K920939 | DYNATRON 300 ULRASOUND | Dynatronics Laser Corp. | IMG | Class II | 1993-03-04 |
| K923428 | PANDA | Etac Us, Inc. | IOR | Class I | 1993-03-04 |
| K924013 | MACAW | Zygo Industries, Inc. | ILQ | Class II | 1993-03-04 |
| K924015 | PARROT | Zygo Industries, Inc. | ILQ | Class II | 1993-03-04 |
| K923498 | BIPHASIC UNIT | Willows Health Center | IPF | Class II | 1993-03-04 |
| K923501 | HIGH VOLT UNIT | Willows Health Center | IPF | Class II | 1993-03-04 |
| K924014 | SECRETARY | Zygo Industries, Inc. | ILQ | Class II | 1993-03-04 |
| K924030 | SCRIBE | Zygo Industries, Inc. | ILQ | Class II | 1993-03-04 |
| K922488 | PHASIS ELECTROMYOGRAPH | Biosound, Inc. | IKN | Class II | 1993-03-02 |
| K925680 | LSI SYSTEM IV INTERFERENTIAL,MUSCLE STIMULATOR | M.S.P. , Ltd. | IPF | Class II | 1993-03-02 |
| K923254 | THERABEAM INFRARED HEAT LAMP | Strategic Alliances Corp. | ILY | Class II | 1993-02-23 |
| K922089 | PNEUMATHERM | National Pain Institute | IRT | Class II | 1993-02-23 |
| K924654 | FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT | Sutter Corp. | BXB | Class I | 1993-02-22 |
| K924905 | MEDI-PLINTH | Medi-Man Rehabilitation Products, Inc. | INQ | Class I | 1993-02-16 |
| K924093 | ELECTRIC HI LO TILT TABLE | Midland Mfg. Co. | INQ | Class I | 1993-02-12 |
| K924686 | REM-AIR | Mellenair Ent., Inc. | INX | Class II | 1993-02-12 |
| K925146 | FOLDING, WHEELCHAIR | Brownstone Trading Co. | IOR | Class I | 1993-02-12 |
| K923804 | PORTABLE LIFT SEAT | Frank H. Speckhart, P.E. | INO | Class II | 1993-02-12 |
| K923912 | MOORE MANUFACTURE MODEL-MHBTL | Moore Mfg., Inc. | ILK | Class II | 1993-02-12 |
| K923805 | POWER PILLOW | Nova Teknic, Inc. | BXB | Class I | 1993-02-12 |
| K924414 | THE BTE DYNAMIC LIFT | Baltimore Therapeutic Equipment Co. | IKK | Class II | 1993-02-12 |
| K925594 | MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE | Tri W-G, Inc. | INQ | Class I | 1993-02-12 |
| K924441 | U.S. MEDICAL PS-6000 WHEELCHAIR SCALE | U.S. Medical Corp. | INF | Class I | 1993-02-12 |
| K923857 | ARTROMOT SB ELBOW ATTACHMENT | Buckman Co., Inc. | BXB | Class I | 1993-02-12 |
| K924521 | DISPOSABLE CONCENTRIC NEEDLE ELECTRODE | Chalgren Enterprises, Inc. | IKT | Class II | 1993-02-12 |
| K923366 | TILT SEATING SYSTEM | Labac Systems, Inc. | KNN | Class I | 1993-02-12 |
| K925247 | STONEHEART ROLLER AID | Stoneheart, Inc. | INM | Class I | 1993-02-12 |
| K924848 | KAYE SCOOT-ABOUT, MODEL SB1 | Kaye Products, Inc. | INM | Class I | 1993-02-12 |
| K925336 | VALU-PLUS PAD | Valmed, Inc. | KNN | Class I | 1993-02-12 |
| K924314 | MOBILE STANDING FRAME | Metatech Corp. | IPL | Class II | 1993-02-12 |
| K923977 | AKROTECH 4000 | Lumex, Inc. | IOQ | Class II | 1993-02-12 |
| K925272 | PEDIATRIC TILT CHAIR | Labac Systems, Inc. | IOR | Class I | 1993-02-12 |
| K915876 | HOTPAD | Ten Comfort Corp. | IME | Class I | 1993-02-12 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.