Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 48
- Latest Decision
- 1981-09-11
Clearances · page 52 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K812350 | WHEELCHAIR ACCESSORIES | Fred Sammons, Inc. | KNO | Class I | 1981-09-11 |
| K812347 | RAISED CHAIR W/FOOT PLATFORM | Fred Sammons, Inc. | INN | Class I | 1981-09-11 |
| K812319 | THERAPY BENCH | Kaye Products, Inc. | IOD | Class I | 1981-08-31 |
| K811482 | INCONTINENT PAD | Fred Sammons, Inc. | KNO | Class I | 1981-08-25 |
| K811395 | EMPI MODEL 710, NMS | Empi | IPF | Class II | 1981-08-24 |
| K812099 | CASH ORTHOSIS | David Hendricks, C.P.O. | IPY | Class I | 1981-08-13 |
| K812033 | THE LYMAN BATHCHAIR | The Lyman Bathchair Corp. | ILJ | Class II | 1981-08-13 |
| K812064 | POLI-AXIAL KNEE CAGE | Generation II Orthotics, Inc. | ITM | Class I | 1981-08-13 |
| K812094 | AIRCAST PNEUMATIC KNEE BRACE | Aircast, Inc. | ITQ | Class I | 1981-08-13 |
| K811956 | AUTONORM & NERV-A-NORM | Autonomic Equipment Supply Co, | KNM | Class I | 1981-07-31 |
| K811782 | SOFT & STROKE | Phoenix Intl. Marketing, Inc. | ISA | Class I | 1981-07-31 |
| K811803 | JAPANESE HOTZIE | Consolidated Health & Sports Prod. | IMD | Class I | 1981-07-31 |
| K811502 | STIMULATOR, FACIAL-MODELS SF-100 & 200 | Rcx-Western, Inc. | IPF | Class II | 1981-07-24 |
| K811250 | ELECTRONIC MUSCLE STIMULATOR | Electrola | IPF | Class II | 1981-07-24 |
| K811904 | CENTURY HYDRO-SAN THERAPY TANK | Century Manufacturing Co. | ILJ | Class II | 1981-07-20 |
| K811903 | CENTURY HYDROTHERAPY PUMP | Century Manufacturing Co. | ILJ | Class II | 1981-07-20 |
| K811750 | MULTITUBULAR THORACIC AIR SPLINTS | Roger Cestac & Assoc. | IPT | Class I | 1981-07-20 |
| K811754 | CRYSTONA | Smith & Nephew, Inc. | ITG | Class I | 1981-07-20 |
| K811891 | NORELCO MASSAGER PLUS HEAT BELT | North American Philips Corp. | ISA | Class I | 1981-07-20 |
| K811524 | AQUACADE | Respiratory Care, Inc. | LHC | Class I | 1981-07-01 |
| K811704 | MULTITUBULAR AIR SPLINT KIT | Roger Cestac & Assoc. | IQI | Class I | 1981-07-01 |
| K811689 | CYLINDER KNEE CAST/SPLINT | Surgical Appliance Industries, Inc. | ITQ | Class I | 1981-06-25 |
| K811690 | ANKLE-FOOT CAST/SPLINT | Surgical Appliance Industries, Inc. | IQI | Class I | 1981-06-25 |
| K811656 | POWERED WHEELCHAIR | The Oec Group | ITI | Class II | 1981-06-25 |
| K811483 | STIM STAND | Fred Sammons, Inc. | ILP | Class I | 1981-06-16 |
| K811484 | SEATING STOOLS | Fred Sammons, Inc. | INN | Class I | 1981-06-16 |
| K811486 | WHEELCHAIR RAMPS | Fred Sammons, Inc. | KNO | Class I | 1981-06-16 |
| K811172 | VICON | Oxford Medilog, Inc. | LXJ | Class II | 1981-06-16 |
| K811485 | WALKER/CRUTCH BAG | Fred Sammons, Inc. | ITJ | Class I | 1981-06-16 |
| K811494 | LUMBO-SACRAL FLEXION ORTHOSIS | Surgical Appliance Industries, Inc. | IPY | Class I | 1981-06-16 |
| K811492 | DRESSING ADAPTORS | Fred Sammons, Inc. | ILD | Class I | 1981-06-12 |
| K811493 | CRUTCH & WALKER PADS | Fred Sammons, Inc. | INP | Class I | 1981-06-12 |
| K810975 | MINITONE | Bloomex International, Inc. | IPF | Class II | 1981-06-12 |
| K811488 | FEEDING AID KIT | Fred Sammons, Inc. | ILC | Class I | 1981-06-12 |
| K811456 | ORTHO-FRAC KIT | Orthomedics | IQI | Class I | 1981-06-12 |
| K811487 | BOOK HOLDER | Fred Sammons, Inc. | ILP | Class I | 1981-06-12 |
| K810634 | FIRM-A-TRON | Biotron , Ltd. | IPF | Class II | 1981-06-12 |
| K811491 | WHEELCHAIR ACCESSORIES | Fred Sammons, Inc. | KNO | Class I | 1981-06-12 |
| K811489 | SCOOTER BOARD | Fred Sammons, Inc. | KNL | Class I | 1981-06-12 |
| K811490 | FOREARM & KNEE STRAPS | Fred Sammons, Inc. | IQI | Class I | 1981-06-12 |
| K811438 | ACRATRAC R | Avratronics Corp. | INW | Class I | 1981-06-09 |
| K811343 | HUMERAL FRACTURE CAST BRACE | Deseret Medical, Inc. | IQI | Class I | 1981-05-28 |
| K811301 | TUBMATE | American Stair-Glide Corp. | ILS | Class I | 1981-05-27 |
| K811164 | URETHANE ORTHOPAEDIC CASTING TAPE | Hexcel Medical | ITG | Class I | 1981-05-27 |
| K811297 | CERVICAL SUPPORT | Orthomedics | IQF | Class I | 1981-05-27 |
| K811159 | DYNASOUND 801 | Dynawave, Corp. | IMI | Class II | 1981-05-27 |
| K811298 | EXECUTIVE COLLAR | Orthomedics | IQK | Class I | 1981-05-27 |
| K811206 | SELF HEATING DISPOSABLE HEAT PAD | Ensar Corp. | IMD | Class I | 1981-05-21 |
| K811176 | TIGGES SPINAL | The Tiggs Co. | IPW | Class I | 1981-05-15 |
| K810513 | ELECTRODYN CII-INTERFERENTIAL MUSCLE | Nemectron Medical, Inc. | IPF | Class II | 1981-05-11 |
| K811035 | PRO COMFORT TENNIS ELBOW SUPPORT/WRIST | Scholl, Inc. | IQI | Class I | 1981-04-29 |
| K810877 | ORTHOSIS BANDAGES | Ortho-Cast, Inc. | ITG | Class I | 1981-04-17 |
| K810526 | RICH-MAR HV II SELECT-A-PULSE | Rich-Mar Corp. | IMG | Class II | 1981-04-03 |
| K810528 | MODEL EM-IR | Myo-Tronics Research, Inc. | KZM | Class II | 1981-03-31 |
| K810225 | LITRONIC STIMULATOR | Med-Western Electronics, Inc. | IPF | Class II | 1981-03-30 |
| K810650 | CRUTCH TIPS & GRIPS | First Industries, Inc. | INP | Class I | 1981-03-26 |
| K810693 | CURITY PERINEAL COLD PACK | The Kendal Co. | IMD | Class I | 1981-03-26 |
| K810692 | CURITY PERINEAL WARM PACK | The Kendal Co. | IMD | Class I | 1981-03-26 |
| K810676 | CONVAID CRUISER CP4M | Convaid Products, Inc. | LBE | Class I | 1981-03-26 |
| K810633 | WONDER WARMER | Montvale Products, Inc. | IMD | Class I | 1981-03-26 |
| K810649 | INVALID CUSHION | First Industries, Inc. | KIC | Class I | 1981-03-26 |
| K802804 | NEMECTRODYN 8 | Nemectron Medical, Inc. | IPF | Class II | 1981-03-16 |
| K810246 | ELITE | Bloomex International, Inc. | IPF | Class II | 1981-03-16 |
| K810496 | VERI/PMS MODEL 815 | Verite | IPF | Class II | 1981-03-13 |
| K810557 | HIP ABDUCTION SPLINT | Orthomedics | IOZ | Class I | 1981-03-13 |
| K810555 | SCOLIOSIS ORTHOTIC SYSTEM | Orthomedics | IQF | Class I | 1981-03-13 |
| K810556 | SPINAL EXTENSION BRACE | Orthomedics | IPY | Class I | 1981-03-13 |
| K810554 | LUMBAR FLEXION BRACE | Orthomedics | IPY | Class I | 1981-03-13 |
| K810440 | SILICONE ELBOW, BED AND CHAIR PADS | Fred Sammons, Inc. | KIC | Class I | 1981-03-12 |
| K810247 | MBI-4 | Bloomex International, Inc. | IPF | Class II | 1981-03-10 |
| K810543 | NEO-WAVE SYSTEM | Gaymar Industries, Inc. | INX | Class II | 1981-03-06 |
| K803314 | SKIN BEAUTY CLEANSER & TONER | Dynex International, Ltd. | IPF | Class II | 1981-03-06 |
| K810448 | WHEELCHAIR ACCESSORIES | Fred Sammons, Inc. | KNO | Class I | 1981-03-04 |
| K810445 | MECHANICAL TABLE | Fred Sammons, Inc. | INW | Class I | 1981-03-04 |
| K810452 | NON-POWERED COMMUNICATION SYSTEMS | Fred Sammons, Inc. | ILP | Class I | 1981-03-04 |
| K810446 | VIBRATOR | Fred Sammons, Inc. | IRO | Class I | 1981-03-04 |
| K810457 | GROOMING ADAPTORS | Fred Sammons, Inc. | ILW | Class I | 1981-03-04 |
| K810320 | HEATPAC | Shinsei Corp. | IMB | Class II | 1981-03-04 |
| K810453 | DRESSING ADAPTORS | Fred Sammons, Inc. | ILD | Class I | 1981-03-04 |
| K810450 | TRUNCAL ORTHOSIS | Fred Sammons, Inc. | IQE | Class I | 1981-03-04 |
| K810456 | HYGIENE ADAPTORS | Fred Sammons, Inc. | ILS | Class I | 1981-03-04 |
| K810454 | HOMEMAKING UTENSILS | Fred Sammons, Inc. | IKW | Class I | 1981-03-04 |
| K810451 | REUSEABLE HOT & COLD PACKS | Fred Sammons, Inc. | IME | Class I | 1981-03-04 |
| K810455 | EATING UTENSILS | Fred Sammons, Inc. | ILC | Class I | 1981-03-04 |
| K810449 | TRANSFER AIDS | Fred Sammons, Inc. | IKX | Class I | 1981-03-04 |
| K810439 | BODY STRAP | Fred Sammons, Inc. | KNO | Class I | 1981-03-04 |
| K810444 | NON-MEASURING EXERCISERS | Fred Sammons, Inc. | ION | Class I | 1981-03-04 |
| K810443 | LIMB ORTHOSIS | Fred Sammons, Inc. | IQI | Class I | 1981-03-04 |
| K810447 | MAGIC CUSHION MASSAGER | Fred Sammons, Inc. | ISA | Class I | 1981-03-04 |
| K810442 | HAND SPLINTS AND COMPONENTS | Fred Sammons, Inc. | ILH | Class I | 1981-03-04 |
| K810402 | ACE COLD BANDAGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | IME | Class I | 1981-03-04 |
| K810244 | PORTA-PULS MUSCLE STIMULATOR | General Physiotherapy, Inc. | IRO | Class I | 1981-02-26 |
| K810044 | MUSCLE STIMULATOR | Micron Instruments, Inc. | IPF | Class II | 1981-02-26 |
| K810354 | PERCUSS-O-FLEX FOOT & HAND MASSAGER | Modern Reflexology, Inc. | ISA | Class I | 1981-02-23 |
| K810238 | SUPINE STRESS SYSTEM | O'Neill | BXB | Class I | 1981-02-13 |
| K810275 | GRAB BARS | Maddak, Inc. | IKX | Class I | 1981-02-12 |
| K810288 | AIRCAST TENNIS ARM BAND | Aircast, Inc. | IQI | Class I | 1981-02-12 |
| K810228 | SORBOTHANE | Hamilton Kent | KNP | Class I | 1981-02-10 |
| K810125 | INERTIAL EXTENSILIZER CHIRO. ADJ. TABLE | The Inertial Corp. | INQ | Class I | 1981-02-09 |
| K802687 | SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS | Intelligent Software Systems, Inc. | ILQ | Class II | 1981-02-04 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.