Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 42
- Latest Decision
- 1982-05-21
Clearances · page 51 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K821237 | NEUROMATIC 2000 | Disa Electronics | IKN | Class II | 1982-05-21 |
| K821404 | LIGHT WEIGHT ALUMINUM WALKER | Manuco Manufacturing Co., Inc. | ITJ | Class I | 1982-05-21 |
| K820906 | SPENCO CRYOPRESS | Spenco Medical Corp. | IMD | Class I | 1982-05-13 |
| K820663 | BOGER AUTO-TRACTION DEVICE | D.C. Medical Device, Inc. | ILZ | Class I | 1982-05-03 |
| K820884 | ELECTRICAL MUSCLE STIMULATOR | Nitron Electronics | IPF | Class II | 1982-04-29 |
| K821046 | COMPRES PORTABLE HEAT PADS | S.C. Johnson & Son, Inc. | IMD | Class I | 1982-04-29 |
| K821016 | QUADRUPLE JOGGER EXERCISER | Industrial Energy Specialists, Inc. | BXB | Class I | 1982-04-26 |
| K820784 | CLINIC 2000 MODEL MULTI-FRECODYN DEVICE | Dimeco | IPF | Class II | 1982-04-22 |
| K820761 | PALM BEACH SEATING SYSTEM | Pb Sales C/O Geller & Bozeman | KNN | Class I | 1982-04-21 |
| K821009 | BATHTUB GRAB BAR | Guardian Products Co., Inc. | ILS | Class I | 1982-04-21 |
| K821402 | LIGHT WEIGHT ALUMINUM CANES | Manuco Manufacturing Co., Inc. | IPS | Class I | 1982-04-21 |
| K821010 | BATHTUB TRANSFER BENCH | Guardian Products Co., Inc. | IKX | Class I | 1982-04-21 |
| K820964 | WHEELCHAIR PAL | Pryor Products | KNO | Class I | 1982-04-16 |
| K820901 | COLD ROLL | North Bank Labs, Inc. | IME | Class I | 1982-04-15 |
| K820858 | ESCORT | Amigo Sales, Inc. | INM | Class I | 1982-04-08 |
| K820826 | STAX FINGER SPLINT | Conco Medical Co. | ILH | Class I | 1982-04-08 |
| K820711 | WALK-A-CYCLE | Walk-A-Cycle Division | ITJ | Class I | 1982-04-08 |
| K820590 | ORTHOPEDIC SOFT GOODS | Abco Dealers, Inc. | ILI | Class I | 1982-03-26 |
| K820548 | POWERED TREADMILL | Ogden Health Products | IOL | Class I | 1982-03-15 |
| K820591 | MECHANICAL CHAIR | Kaye Products, Inc. | LBE | Class I | 1982-03-15 |
| K820444 | HEART-ALERT | Medical Equipment Devices, Inc. | KHX | Class I | 1982-03-12 |
| K820478 | QUINTON Q55 MEDICAL TREADMILL | Quinton, Inc. | IOL | Class I | 1982-03-11 |
| K813443 | BX-400 SPORT | Bloomex International, Inc. | IPF | Class II | 1982-03-08 |
| K820476 | KEM-2 | Medical Graphics Corp. | BXB | Class I | 1982-03-08 |
| K820469 | WARM & FORM KNEE SUPPORTS | Thermo-Mold Medical Products, Inc. | IQI | Class I | 1982-03-08 |
| K813604 | OMNI STIM II | Omni Intl., Inc. | IPF | Class II | 1982-03-08 |
| K820359 | HOT MINI 15 & HOT MINI 24 | Hot Mini International, Inc. | IMD | Class I | 1982-03-08 |
| K813410 | BX-400 JESSE JIMBODY | Bloomex International, Inc. | IPF | Class II | 1982-03-08 |
| K820505 | ANKLE/FOOT EXTERNAL | Mauch Laboratories, Inc. | ISH | Class I | 1982-03-08 |
| K813533 | ELECTRIC MUSCLE STIMULATOR | Myo-Tronics Research, Inc. | IPF | Class II | 1982-03-05 |
| K820366 | BECSIC COLLAR | Blackstone & Breglio Industries | IQK | Class I | 1982-03-01 |
| K820381 | FINGER PROTECTOR | Conco Medical Co. | ILH | Class I | 1982-03-01 |
| K820382 | FROG SPLINT | Conco Medical Co. | ILH | Class I | 1982-03-01 |
| K820380 | CURVED FINGER SPLINT | Conco Medical Co. | ILH | Class I | 1982-03-01 |
| K820168 | MENTOR ACTIVATOR NEUROMUSCULAR STIMU | Mentor Corp. | IPF | Class II | 1982-02-24 |
| K820383 | FINGER COT | Conco Medical Co. | ILH | Class I | 1982-02-24 |
| K813593 | INTELECT MODEL 200 | Chattanooga Group, Inc. | IMI | Class II | 1982-02-22 |
| K813594 | INTELECT MODEL 700 | Chattanooga Group, Inc. | IMG | Class II | 1982-02-22 |
| K813108 | MODEL 500 VERI/500 | Verite | IPF | Class II | 1982-02-19 |
| K813181 | ELECTROC-GYM | Electrola | IPF | Class II | 1982-02-19 |
| K820282 | ACE BRAND INSTANT COLD PACK | Bd Becton Dickinson Vacutainer Systems Preanalytic | IMD | Class I | 1982-02-12 |
| K820140 | WEBRIL CAST PADDING | Stan-Pak Ent. | ITG | Class I | 1982-02-12 |
| K820155 | SPECIALIST CAST PADDING | Stan-Pak Ent. | ITG | Class I | 1982-02-12 |
| K813052 | ULTRACAST WATERLESS SYNTHETIC RESIN CAST | Zimmer, Inc. | ITG | Class I | 1982-02-04 |
| K820236 | WATER FLOATATION PAD | Gottfried Medical, Inc. | KIC | Class I | 1982-02-04 |
| K813486 | TELETRED GAIT ANALYSIS SYSTEM | Structural Analysis Systems, Inc. | IOL | Class I | 1982-01-29 |
| K813485 | SAS EDUCATIONAL CHART | Structural Analysis Systems, Inc. | IOL | Class I | 1982-01-29 |
| K820120 | PATIENT GUIDED KNEE EXERCISER | Richard'S Medical Equip., Inc. | BXB | Class I | 1982-01-29 |
| K820051 | OBUS FORME ORTHOPEDIC BRACE, UPRIGHT | Obus Forme, Ltd. | IQE | Class I | 1982-01-29 |
| K813456 | HIGH VOLTAGE GALVANIC STIMULATOR 550 | Chattanooga Group, Inc. | IPF | Class II | 1982-01-29 |
| K820068 | COLD-HOT PACK | Hospital Marketing Services Co., Inc. | IME | Class I | 1982-01-28 |
| K820083 | SUTTER CPM | Sutter Biomedical, Inc. | BXB | Class I | 1982-01-28 |
| K813451 | UVA FLUORESCENT TANNING LAMPS | North American Philips Corp. | IOB | Class II | 1982-01-28 |
| K813631 | JAR HOLDER & OPENER | Fred Sammons, Inc. | IKW | Class I | 1982-01-19 |
| K812984 | SLIMTRONICS 2000 | Ems Dist. | IPF | Class II | 1982-01-19 |
| K813629 | BK-6111 HI-D TRANSFER BOARD | Fred Sammons, Inc. | IKX | Class I | 1982-01-19 |
| K813635 | CHILDS TOILET TRAINER HYGIENE AIDS | Fred Sammons, Inc. | ILS | Class I | 1982-01-19 |
| K813636 | BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR | Fred Sammons, Inc. | KNN | Class I | 1982-01-19 |
| K812752 | MICRO MED INT'L MICRO SOUND US-100 | N-Tron Electronics | IMI | Class II | 1982-01-19 |
| K813628 | BK-7182 INSTANT COLD PACK | Fred Sammons, Inc. | IMD | Class I | 1982-01-19 |
| K813634 | ONE HANDED SHOE FASTENER | Fred Sammons, Inc. | ILD | Class I | 1982-01-19 |
| K813627 | BK-6453 RIMMED ACRYLIC LAP TRAY KIT | Fred Sammons, Inc. | KNO | Class I | 1982-01-19 |
| K813632 | COLOR CODED WEIGHT CUFFS | Fred Sammons, Inc. | IOD | Class I | 1982-01-19 |
| K813630 | BK-1129 BOTTLE STRAW | Fred Sammons, Inc. | ILC | Class I | 1982-01-19 |
| K813633 | MODELING COMPOUND AND FOAM EXERCISER | Fred Sammons, Inc. | ION | Class I | 1982-01-19 |
| K813584 | CLINITRON AIR FLUIDIZED SUPPORT SYSTEM | Uhi Corp. | INX | Class II | 1982-01-12 |
| K812851 | SBP-16 CLINIC MUSCLE STIMULATOR | Southwestern Bio-Physical Corp. | IPF | Class II | 1981-12-29 |
| K813219 | CARAFLEX ELASTIC POLYMER PLASTER BANDA | Carapace, Inc. | ITG | Class I | 1981-12-17 |
| K812853 | OSRAM UVA LAMP | Osram GmbH | IOB | Class II | 1981-12-09 |
| K813225 | GEL FLOTATION CUSHION | Jefferson Industries, Inc. | KIC | Class I | 1981-12-03 |
| K813008 | RESPOND II...NEUROMUSCULAR STIMULATOR | Medtronic Vascular | IPF | Class II | 1981-12-02 |
| K812538 | ELITE | Biotone International, Inc. | IPF | Class II | 1981-12-01 |
| K813099 | BACK RIE | Back Rite | ION | Class I | 1981-11-24 |
| K813104 | POWER DRIVE WHEELCR | Intl. Medical Equipment Corp. | ITI | Class II | 1981-11-20 |
| K812902 | ACUPRESS VIBRATOR | Eicona Corp. | IRO | Class I | 1981-11-10 |
| K812806 | KT-1000 DEVICE | Medmetric Corp. | LYH | Class I | 1981-11-10 |
| K812720 | BODAI PATIENT COMMUNICATOR | Sontek Industries, Inc. | ILQ | Class II | 1981-11-05 |
| K811737 | BIO-TONE MODEL 4 | Biotone International, Inc. | IPF | Class II | 1981-10-14 |
| K812715 | TECA #TE 8 | Teca, Inc. | IKN | Class II | 1981-10-13 |
| K812719 | PROSANA BELT | Bandwagon, Inc. | IQE | Class I | 1981-10-06 |
| K812019 | LOXLEY EMERGENCY CERVICAL COLLAR | Loxley Medical | IQK | Class I | 1981-10-02 |
| K812654 | VELCRO FINGER/TOE SPLINT | Maddak, Inc. | ILH | Class I | 1981-09-25 |
| K812655 | VELCRO SPLINT STRAP FASTENERS | Maddak, Inc. | ILH | Class I | 1981-09-25 |
| K812342 | ZEE EXTRICATION DEVICE | Zee Medical Products Co., Inc. | IQF | Class I | 1981-09-21 |
| K812423 | NEOPRENE KNEE SUPPORT | Surgical Appliance Industries, Inc. | ITQ | Class I | 1981-09-14 |
| K812477 | ARM SLING, POUCH TYPE | Maddak, Inc. | ILI | Class I | 1981-09-14 |
| K812352 | HYGIENE ADAPTORS | Fred Sammons, Inc. | ILS | Class I | 1981-09-14 |
| K812475 | TRANSFER BENCH | Maddak, Inc. | IKX | Class I | 1981-09-14 |
| K812399 | CHAIR, ADJUSTABLE, MECHANICAL | Kaye Products, Inc. | INN | Class I | 1981-09-14 |
| K812422 | CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS | Surgical Appliance Industries, Inc. | IPY | Class I | 1981-09-14 |
| K812474 | BABY WALKER W/TOY CHEST | Maddak, Inc. | ION | Class I | 1981-09-14 |
| K812351 | NON-MEASURING EXERCISERS | Fred Sammons, Inc. | ION | Class I | 1981-09-14 |
| K812483 | SECURA BATH SEAT | Maddak, Inc. | ILS | Class I | 1981-09-14 |
| K812480 | LIMB HOLDER ARM SLING | Maddak, Inc. | ILI | Class I | 1981-09-14 |
| K812401 | CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O | Surgical Appliance Industries, Inc. | IPT | Class I | 1981-09-14 |
| K812478 | MADDACOMFORT SLING | Maddak, Inc. | ILI | Class I | 1981-09-14 |
| K812346 | ALUMINUM SCOOP DISK | Fred Sammons, Inc. | ILC | Class I | 1981-09-11 |
| K812345 | ARM SLINGS | Fred Sammons, Inc. | ILI | Class I | 1981-09-11 |
| K812348 | DESK ARM WHEELCHAIR ARM EXTENSION | Fred Sammons, Inc. | KNN | Class I | 1981-09-11 |
| K812349 | HAND SPLINTS & COMPONENTS | Fred Sammons, Inc. | ILH | Class I | 1981-09-11 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.