Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 40
- Latest Decision
- 1983-03-09
Clearances · page 49 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K830350 | CERVICAL PILLOW | Deip Enterprises, Inc. | IQK | Class I | 1983-03-09 |
| K830348 | VINYL EXTRICATION COLLAR | Deip Enterprises, Inc. | IQK | Class I | 1983-03-09 |
| K830466 | BARS, PARALLEL, EXERCISE | Kaye Products, Inc. | IOE | Class I | 1983-03-09 |
| K830400 | MADDATRAINER HAND EXERCISER | Maddak, Inc. | ION | Class I | 1983-03-09 |
| K830560 | EXERCISER, PASSIVE, NON MEASURING | Kaye Products, Inc. | ION | Class I | 1983-03-09 |
| K830351 | DISPOSABLE EXTRICATION COLLAR | Deip Enterprises, Inc. | IQK | Class I | 1983-03-09 |
| K830245 | HEAD HALTER | Warm & Form, Orthopedic Materials | ILZ | Class I | 1983-03-09 |
| K830285 | REGNELL HYDRAULIC FEMORAL PROTHESIS | Besco Financial Service | KFX | Class II | 1983-03-09 |
| K830369 | POWER FLEX | Biodynamic Technologies of Florida | BXB | Class I | 1983-03-08 |
| K830243 | ABDUCTION PILLOW | Warm & Form, Orthopedic Materials | IOZ | Class I | 1983-03-08 |
| K823681 | MODEL ICPM & ACCESSORIES | Electromedics, Inc. | JFC | Class I | 1983-02-23 |
| K823927 | HIPUSH HANDHELD MASSAGER | New Age Corp. | ISA | Class I | 1983-02-15 |
| K830034 | MODEL EM-2 BIOELECTRIC PROCESSOR | Myo-Tronics Research, Inc. | KZM | Class II | 1983-02-09 |
| K830122 | CONTINUOUS ANATOMICAL PASSIVE EXERCISER | Zimmer, Inc. | BXB | Class I | 1983-02-07 |
| K830146 | PROGRAM. TREADMILL CONTROLLER #645 | Quinton, Inc. | IOL | Class I | 1983-02-02 |
| K830088 | TRACTION 230 | Tri W-G, Inc. | ITH | Class II | 1983-01-24 |
| K823645 | VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR | Fred Sammons, Inc. | KNO | Class I | 1983-01-21 |
| K823654 | SLIP-ON SANDALS FOR MEASURING SHORTNESS | Fred Sammons, Inc. | KNP | Class I | 1983-01-21 |
| K823646 | FRICTION FEEDER | Fred Sammons, Inc. | KNO | Class I | 1983-01-21 |
| K823657 | CARD HOLDER FOR QUADS | Fred Sammons, Inc. | ILT | Class I | 1983-01-21 |
| K823648 | SURGICAL TUBING | Fred Sammons, Inc. | IOD | Class I | 1983-01-21 |
| K823638 | ARM THROUGH FOR WHEELCHAIR BK 6454-01 & | Fred Sammons, Inc. | KNN | Class I | 1983-01-21 |
| K823650 | THERMOELASTOMER HOT/COLD COMPRESS-7187- | Fred Sammons, Inc. | IME | Class I | 1983-01-21 |
| K823644 | FINGER FLEXION SPLINT | Fred Sammons, Inc. | ILH | Class I | 1983-01-21 |
| K823640 | BATH TUB SAFETY BAR | Fred Sammons, Inc. | IKX | Class I | 1983-01-21 |
| K823656 | SOFT CATCHER'S MITT | Fred Sammons, Inc. | ILT | Class I | 1983-01-21 |
| K823647 | FINGER EXTENSION SPLINT | Fred Sammons, Inc. | ILH | Class I | 1983-01-21 |
| K823649 | THERMOELASTOMER HOT/COLD COMPRESS BK7186 | Fred Sammons, Inc. | IME | Class I | 1983-01-21 |
| K823641 | BATHING CHAIR FOR CHILD | Fred Sammons, Inc. | ILS | Class I | 1983-01-21 |
| K823495 | MOBILIMB-CPM UPPER/LOWER LIMB DEVICE | Synthes (Usa) | BXB | Class I | 1983-01-21 |
| K823236 | BACK ON TRACK INVERSION THERAPY & EXER | Lossing Orthopedic, Inc. | ION | Class I | 1983-01-21 |
| K823637 | ARM THROUGH FOR WHEELCHAIR BK-6458-01 | Fred Sammons, Inc. | KNN | Class I | 1983-01-21 |
| K823085 | BERKELEY CHAIR | Berkeley Electric Wheelchair Co. | ITI | Class II | 1983-01-21 |
| K823639 | BOARD TO TRANSFER PARALYZED PATIENT FROM | Fred Sammons, Inc. | IKX | Class I | 1983-01-21 |
| K823882 | M-BRACE | Buckman Consultants | IPY | Class I | 1983-01-17 |
| K823823 | LUMBOSACRAL SUPPORT | Danek Medical, Inc. | IPY | Class I | 1983-01-14 |
| K823809 | CLAVICAL STRAP | Danek Medical, Inc. | IQJ | Class I | 1983-01-14 |
| K823876 | BERKELEY FORK | Berkeley Electric Wheelchair Co. | KNN | Class I | 1983-01-14 |
| K823873 | CHAIN SILENCER | Berkeley Electric Wheelchair Co. | KNN | Class I | 1983-01-14 |
| K823808 | VARIOUS ARM SLING | Danek Medical, Inc. | ILI | Class I | 1983-01-14 |
| K823810 | A.C. SPLINT | Danek Medical, Inc. | ILI | Class I | 1983-01-14 |
| K823812 | VARIOUS SUPPORTS AND SPLINTS | Danek Medical, Inc. | IQI | Class I | 1983-01-14 |
| K823811 | OVERHEAD ARM SLINGS | Danek Medical, Inc. | ILE | Class I | 1983-01-14 |
| K823874 | BERKELEY BRAKE | Berkeley Electric Wheelchair Co. | KNN | Class I | 1983-01-14 |
| K823562 | EMG MODULES FOR POLYGRAPH SYSTEM | Nihon Kohden America, Inc. | IKN | Class II | 1983-01-14 |
| K823877 | BERKELEY HARNESS | Berkeley Electric Wheelchair Co. | KNN | Class I | 1983-01-14 |
| K823539 | SUTTER CPM | Sutter Biomedical, Inc. | BXB | Class I | 1983-01-14 |
| K823903 | RUBBER INFLATABLE RING | Duro-Med Ind., Inc. | KIC | Class I | 1983-01-14 |
| K823820 | ABDUCTION PILLOW | Danek Medical, Inc. | IOZ | Class I | 1983-01-14 |
| K823816 | WHEELCHAIR PATIENT RESTRAINTS | Danek Medical, Inc. | KNO | Class I | 1983-01-14 |
| K823822 | ANKLE WEIGHTS | Danek Medical, Inc. | IOD | Class I | 1983-01-14 |
| K823814 | HOT/COLD PACK HOLDERS | Danek Medical, Inc. | IME | Class I | 1983-01-14 |
| K823875 | CHAIN KIT | Berkeley Electric Wheelchair Co. | KNN | Class I | 1983-01-14 |
| K823624 | HOLDER FOR MOUTH STICK | Fred Sammons, Inc. | ILP | Class I | 1982-12-30 |
| K823662 | RIB BELT (UNIVERSAL) | Warm & Form, Orthopedic Materials | IPX | Class I | 1982-12-30 |
| K823622 | INSULATED THERMOELASTOMER MITT | Fred Sammons, Inc. | IMA | Class I | 1982-12-30 |
| K823658 | DELUXE KNEE IMMOBILIZER(UNIVERSAL) | Warm & Form, Orthopedic Materials | ITQ | Class I | 1982-12-30 |
| K823663 | ABDOMINAL BINDER | Warm & Form, Orthopedic Materials | KTD | Class I | 1982-12-30 |
| K823666 | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | Warm & Form, Orthopedic Materials | ILH | Class I | 1982-12-30 |
| K823625 | MOUTH STICK KIT | Fred Sammons, Inc. | ILP | Class I | 1982-12-30 |
| K823608 | PICTURES & WORD IDENTIFICATION CVA PAT | Fred Sammons, Inc. | ILP | Class I | 1982-12-30 |
| K823665 | ROTATION BOOT | Warm & Form, Orthopedic Materials | KNP | Class I | 1982-12-30 |
| K823664 | UNIVERSAL SLING, SLING & SWATHE | Warm & Form, Orthopedic Materials | ILI | Class I | 1982-12-30 |
| K823667 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | IQK | Class I | 1982-12-30 |
| K822240 | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. | American Mcgaw | KFX | Class II | 1982-12-30 |
| K823661 | CLAVICLE SUPPORT | Warm & Form, Orthopedic Materials | IQJ | Class I | 1982-12-30 |
| K823626 | DISPOSABLE TOOTH BRUSH | Fred Sammons, Inc. | ILS | Class I | 1982-12-30 |
| K823612 | ADJ. WOODEN BOARD FOR WRITING | Fred Sammons, Inc. | ILP | Class I | 1982-12-30 |
| K823659 | PELVIC TRACTION BELT | Warm & Form, Orthopedic Materials | ILZ | Class I | 1982-12-30 |
| K823603 | FORMED PLASTIC PANTY HOSE AID | Fred Sammons, Inc. | ILD | Class I | 1982-12-28 |
| K823627 | LEATHER I VELCRO SHOE FASTENER REPAIR | Fred Sammons, Inc. | ILD | Class I | 1982-12-28 |
| K823636 | ARM THROUGH FOR WHEELCHAIR BK-6459-01 & | Fred Sammons, Inc. | KNO | Class I | 1982-12-28 |
| K823633 | TURNERS FOR KNOBS | Fred Sammons, Inc. | IKW | Class I | 1982-12-28 |
| K823606 | PLASTIC BREAK RESISTANT MIRROR | Fred Sammons, Inc. | ILS | Class I | 1982-12-28 |
| K823607 | CARPET SWEEPER | Fred Sammons, Inc. | IKW | Class I | 1982-12-28 |
| K823635 | CUSHIONS FOR WHEELCHAIR ARMS | Fred Sammons, Inc. | KNO | Class I | 1982-12-28 |
| K823604 | ROD W/HOOK TO PULL CLOTHES ON | Fred Sammons, Inc. | ILD | Class I | 1982-12-28 |
| K823628 | LEATHER & VELCRO SHOE FASTENER | Fred Sammons, Inc. | ILD | Class I | 1982-12-28 |
| K823632 | LONG HANDLED FOLDING HAIRBRUSH | Fred Sammons, Inc. | ILW | Class I | 1982-12-28 |
| K823634 | CHAIR OR BED LEG EXTENDERS | Fred Sammons, Inc. | IKX | Class I | 1982-12-28 |
| K823623 | INFLATABLE HEAVY PLASTIC EXERCISER | Fred Sammons, Inc. | ION | Class I | 1982-12-28 |
| K823605 | PORTABLE ELECTRIC CAN OPENER | Fred Sammons, Inc. | IKW | Class I | 1982-12-28 |
| K823617 | PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR | Fred Sammons, Inc. | ILP | Class I | 1982-12-22 |
| K823610 | BK-4015 ECONOMY COMMUNICATION SHEET | Fred Sammons, Inc. | ILP | Class I | 1982-12-22 |
| K823601 | WRIST SUPPORT | Fred Sammons, Inc. | ILH | Class I | 1982-12-22 |
| K823618 | PROGRESSIVE RESISTANCE EXERCISE CUFF | Fred Sammons, Inc. | ION | Class I | 1982-12-22 |
| K823602 | REGULAR SHOE HORN W/CYLINDRICAL HANDLE | Fred Sammons, Inc. | ILD | Class I | 1982-12-22 |
| K823613 | PLASTIC STOP TO HOLD TELEPHONE BUTTON | Fred Sammons, Inc. | ILP | Class I | 1982-12-22 |
| K823595 | HEAD SUPPORT FOR WHEELCHAIR | Fred Sammons, Inc. | KNO | Class I | 1982-12-22 |
| K823619 | PLASTIC ELASTOMER ENCASED IN TERRY CLOTH | Fred Sammons, Inc. | ION | Class I | 1982-12-22 |
| K823616 | PLASTIC SLIP-ON PEN/PENCIL HOLDER | Fred Sammons, Inc. | ILP | Class I | 1982-12-22 |
| K823594 | PLASTIC BUILT-UP HANDLE EATING UTENSILS | Fred Sammons, Inc. | ILC | Class I | 1982-12-22 |
| K823600 | SOLID WOOD CONE | Fred Sammons, Inc. | IOD | Class I | 1982-12-22 |
| K823609 | KIT OF WORDS & LTRS TO RE-LEARN-BK4014 | Fred Sammons, Inc. | ILP | Class I | 1982-12-22 |
| K823596 | CLAMP ON HOLDER FOR A GLASS OR CUP | Fred Sammons, Inc. | KNO | Class I | 1982-12-22 |
| K823620 | PLASTIC ELASTOMER IN CUBE FORM EXERCISE | Fred Sammons, Inc. | ION | Class I | 1982-12-22 |
| K823615 | TELEPHONE ADAPTOR-PERSONS CANT ANSWER | Fred Sammons, Inc. | ILP | Class I | 1982-12-22 |
| K823614 | FLEXIBLE HOLDER TO HOLD PHONE RECEIVER | Fred Sammons, Inc. | ILP | Class I | 1982-12-22 |
| K823277 | THE PROGRESSIVE CHAIR | Progressive Productions , Ltd. | INN | Class I | 1982-12-13 |
| K822924 | MINISTIM 180 | Micron Instruments, Inc. | IPF | Class II | 1982-12-13 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.