Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 55
- Latest Decision
- 1982-12-07
Clearances · page 50 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K823327 | PORTABLE SHOWER BATH | Wall Manufacturer, Inc. | ILM | Class II | 1982-12-07 |
| K823095 | KINETIC MOTION BED | Motion Manufacturers, Inc. | IKZ | Class II | 1982-12-03 |
| K823301 | MICROPAD | Fia Man Co. | IRT | Class II | 1982-12-03 |
| K823393 | STAX FINGER SPLINTS | Orthopedic Systems, Inc. | ILH | Class I | 1982-12-03 |
| K823399 | COVER LIMB | Orthopedic Systems, Inc. | IPM | Class I | 1982-11-29 |
| K823397 | ANATOMIC FRACTURE BRACE | Orthopedic Systems, Inc. | ITQ | Class I | 1982-11-29 |
| K823396 | FREE FLEX HEEL HEIGHT ADJUSTOR | Orthopedic Systems, Inc. | ISH | Class I | 1982-11-29 |
| K823279 | RESPOND QUADRIFLEX #3129 SINGLE CHANNEL | Medtronic Vascular | IPF | Class II | 1982-11-22 |
| K823113 | BRACE-UP ALL PURPOSE WRIST BAND | Arco Matic, Inc. | IQI | Class I | 1982-11-16 |
| K823175 | SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER | Kinetic Concepts, Inc. | ITI | Class II | 1982-11-16 |
| K823247 | U-WAY QUICKOLLAR | Ems Industries, Inc. | IQK | Class I | 1982-11-16 |
| K823117 | HITCH HIKER | Amigo Sales, Inc. | ITI | Class II | 1982-11-16 |
| K823165 | WRIST SPLING & FOREARM SPLINT | Warm & Form, Orthopedic Materials | ILH | Class I | 1982-11-16 |
| K823164 | ABDOMINAL BINDER | Warm & Form, Orthopedic Materials | KTD | Class I | 1982-11-16 |
| K823159 | DELUXE KNEE IMMOBILIZER | Warm & Form, Orthopedic Materials | ITQ | Class I | 1982-11-10 |
| K823158 | RIB BELT (UNIVERSAL) | Warm & Form, Orthopedic Materials | IPX | Class I | 1982-11-10 |
| K823162 | UNIVERSAL SLING, SLING & SWATHE | Warm & Form, Orthopedic Materials | ILI | Class I | 1982-11-10 |
| K823161 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | IQK | Class I | 1982-11-10 |
| K823157 | CLAVICLE SUPPORT | Warm & Form, Orthopedic Materials | IQJ | Class I | 1982-11-10 |
| K823160 | ROTATION BOOT | Warm & Form, Orthopedic Materials | IQI | Class I | 1982-11-10 |
| K823166 | PELVIC TRACTION BELT | Warm & Form, Orthopedic Materials | ILZ | Class I | 1982-11-10 |
| K823149 | OB TILT TABLE | Orthion Corp. | INW | Class I | 1982-11-05 |
| K823152 | OB HELP ARM | Orthion Corp. | ILE | Class I | 1982-11-05 |
| K823151 | OB TRIPP TRANSPORT CHAIR | Orthion Corp. | INM | Class I | 1982-11-05 |
| K823150 | SESAM TREATMENT TABLE | Orthion Corp. | INQ | Class I | 1982-11-05 |
| K823105 | RESI-WALKER | Orthion Corp. | ITJ | Class I | 1982-11-05 |
| K823155 | LAVATORY SEAT HEIGHTENER | Orthion Corp. | ILS | Class I | 1982-11-05 |
| K823114 | BRACE-UP STOCKING KNEE BRACE | Arco Matic, Inc. | IQI | Class I | 1982-11-05 |
| K823154 | SHOWER STOOL W/HANDLES | Orthion Corp. | IKX | Class I | 1982-11-05 |
| K823156 | COLLAPSABLE LAVATORY HEIGHTENER | Orthion Corp. | ILS | Class I | 1982-11-05 |
| K823153 | BATH TUB SEAT & BATH BOARD | Orthion Corp. | IKX | Class I | 1982-11-05 |
| K822992 | PEOPLE MOVER | Convaid Products, Inc. | INM | Class I | 1982-10-27 |
| K823003 | Q65 MEDICAL TREADMILL | Quinton, Inc. | IOL | Class I | 1982-10-27 |
| K822402 | ROTO REST KINETIC TREATMENT TABLE PEDIA | Kinetic Concepts, Inc. | IKZ | Class II | 1982-10-22 |
| K822906 | PHYSICAL MEDICINE & REHABILITATION EQUIP | I-Rep, Inc. | ION | Class I | 1982-10-15 |
| K822519 | HAWKINS EBA -16 MUSCLE STIMULATOR | A-Zenith Therapeutic Equipment/Supply | IPF | Class II | 1982-10-13 |
| K822287 | BX-500 ELECTRONIC MUSCLE EXERCISER | Bloomex International, Inc. | IPF | Class II | 1982-10-13 |
| K822624 | O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 | Del Mar Avionics | IKN | Class II | 1982-10-06 |
| K822056 | EXER-STIM CONTROLLER | Th Charters, Inc. | IPF | Class II | 1982-10-06 |
| K822783 | FLEX ICE FREEZE PACK | Igloo Corp. | IME | Class I | 1982-10-06 |
| K822767 | UNIVERSAL DYNASPLINT | Dynasplint Systems, Inc. | IQI | Class I | 1982-10-06 |
| K822250 | MYO-TONE, INC. SYSTEM-80 | Myo-Tone, Inc. | IPF | Class II | 1982-09-22 |
| K822696 | MASTER I | Master Medical Services, Inc. | INI | Class II | 1982-09-22 |
| K822693 | ACU-MASSAGE TABLE | H.W.E., Inc. | JFB | Class II | 1982-09-21 |
| K822284 | COMPLY NEUROMUSCULAR STIMULATOR | Omega-Med Intl., Inc. | IPF | Class II | 1982-09-17 |
| K822651 | TOTAL FINGER FLEXION SPLINT | Alimed, Inc. | ILH | Class I | 1982-09-17 |
| K822632 | ELBOW PROSTHESIS | Hosmer Dorrance Corp. | IRE | Class I | 1982-09-14 |
| K821910 | ANESTHESIA & BRAIN MONITOR | Datex Division Instrumentarium Corp. | IKN | Class II | 1982-09-07 |
| K821920 | I.C.E. BOX | Lhs Industries | IRP | Class II | 1982-08-31 |
| K821109 | TRIMMORE ELECTION BEAUTIFIER | Rn Int'L, Inc. | ISA | Class I | 1982-08-31 |
| K822212 | MOTORIZED EXERCISER | W.R. Mccullin | BXB | Class I | 1982-08-31 |
| K822221 | CHIROPRACTIC ADJUSTING TABLE MODEL 646 | Tri W-G, Inc. | INQ | Class I | 1982-08-31 |
| K821836 | PREGNANCY (W) EDGE | Body Therapeutics, Inc. | QSB | Class I | 1982-07-30 |
| K822031 | AUTORANGE MODEL 205 | Tri W-G, Inc. | BXB | Class I | 1982-07-26 |
| K822022 | SPORT SUPPORTS | Ginny, Inc. | IQI | Class I | 1982-07-26 |
| K821809 | THERMOFONTE AIR MESSAGE BATH | Greenfields | ILJ | Class II | 1982-07-23 |
| K820953 | EF2000 | Squire, Sanders & Dempsey | IPF | Class II | 1982-07-22 |
| K821449 | P6S ATHLETIC | Squire, Sanders & Dempsey | IPF | Class II | 1982-07-22 |
| K821903 | DISC-O-AID | M. Dahm International Aps | IKX | Class I | 1982-07-20 |
| K821619 | THE SPORTS HAND | Therapeutic Recreation Systems, Inc. | IRA | Class I | 1982-07-20 |
| K821837 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | IQK | Class I | 1982-07-20 |
| K821827 | GENTLE-LIFT CHAIR | Pride Health Care Equipment | INO | Class II | 1982-07-20 |
| K821692 | PASSIVE HEAT PADS | Biotone International, Inc. | IRT | Class II | 1982-07-13 |
| K821133 | ELECTRICAL VIBRATING DEVICE | Durham Electric Co. | IRO | Class I | 1982-07-09 |
| K821855 | VISCO HANDEX-VARIOUS MODELS | Fred Sammons, Inc. | ION | Class I | 1982-07-02 |
| K821859 | ORTHOLACE 4,5.6 EYELET | Fred Sammons, Inc. | ILD | Class I | 1982-07-02 |
| K821860 | BK-6477 THE DERBY RAISED TOILET SEAT | Fred Sammons, Inc. | ILS | Class I | 1982-07-02 |
| K821255 | ELECTRODYNOGRAM SYSTEM | The Langer Group | KHX | Class I | 1982-07-02 |
| K821857 | BK-5305 MULTIPLE HAND GRID | Fred Sammons, Inc. | ION | Class I | 1982-07-02 |
| K821856 | BK-2082 FOLDING STOCKING AID | Fred Sammons, Inc. | ILD | Class I | 1982-07-02 |
| K821858 | NOTIE STRETCH-LACE-VARIOUS MODELS | Fred Sammons, Inc. | ILD | Class I | 1982-07-02 |
| K821110 | ELECTRONIC MUSCLE EXERCISER | Bloomex International, Inc. | IPF | Class II | 1982-07-01 |
| K820080 | BX-1000 ISOMATIC | Bloomex International, Inc. | IPF | Class II | 1982-07-01 |
| K821651 | E-Z UP ARTHERAPEDIC CHAIR | Medical Device Consultants, Inc. | INN | Class I | 1982-06-24 |
| K821704 | FRACTURE BRACING | Hosmer Dorrance Corp. | IQI | Class I | 1982-06-24 |
| K821682 | TRUNCAL ORTHOSIS | Surgical Appliance Industries, Inc. | IQE | Class I | 1982-06-24 |
| K821256 | COUNTER-ROTATION SYSTEM | The Langer Group | ITN | Class I | 1982-06-23 |
| K820890 | URETHANE ORTHOPAEDIC CASTING TAPE | Hexcel Medical | ITG | Class I | 1982-06-23 |
| K821157 | HETERODYNAMIC | Birtcher Corp. | IPF | Class II | 1982-06-23 |
| K821002 | INVERCHAIR | Inverchair Marketing, Inc. | ITH | Class II | 1982-06-22 |
| K821677 | THE COMMUNICATOR | Robert Swinney. , Ltd. | ILQ | Class II | 1982-06-22 |
| K821403 | LIGHT WEIGHT ALUMINUM CRUTCHES | Manuco Manufacturing Co., Inc. | IPR | Class I | 1982-06-21 |
| K821637 | WIRE-FOAM MP FLEXION SPRING | Fred Sammons, Inc. | ILH | Class I | 1982-06-11 |
| K821635 | SOFT ULNAR DEVIATION SPLINTS | Fred Sammons, Inc. | ILH | Class I | 1982-06-11 |
| K821640 | ORTHOTIC FABRICATION ACCESSORIES | Fred Sammons, Inc. | IQI | Class I | 1982-06-11 |
| K821634 | EZ STAND MOBILE STOOL | Fred Sammons, Inc. | IMM | Class I | 1982-06-11 |
| K821641 | OBTHOSES | Fred Sammons, Inc. | IQI | Class I | 1982-06-11 |
| K821639 | ANKLE FOOT ORTHOSIS | Fred Sammons, Inc. | ITW | Class I | 1982-06-11 |
| K821638 | HYGIENE ADAPTORS | Fred Sammons, Inc. | ILS | Class I | 1982-06-11 |
| K821644 | VACUUM WAND AND UNI-READER | Fred Sammons, Inc. | ILP | Class I | 1982-06-11 |
| K821643 | EATING UTENSILS | Fred Sammons, Inc. | ILC | Class I | 1982-06-11 |
| K821642 | WHEEL CHAIR ACCESSORIES | Fred Sammons, Inc. | KNO | Class I | 1982-06-11 |
| K820938 | HAWKINS ELECTROKINETIC BODY ACTIVATING | Leisure Way | IPF | Class II | 1982-06-11 |
| K821633 | VARIABLE SPEED VIBRATOR, 120V 83-117 VIB | Fred Sammons, Inc. | IRO | Class I | 1982-06-11 |
| K821646 | TINY FLEX-GLASS, SET OF 4 | Fred Sammons, Inc. | IKW | Class I | 1982-06-11 |
| K821645 | BACK SKPPORTS | Fred Sammons, Inc. | IPT | Class I | 1982-06-11 |
| K821636 | ATTACH-A-PAK | Fred Sammons, Inc. | IME | Class I | 1982-06-11 |
| K821582 | WARM'N FORM SPORTS SUPPORTS | Jerome Medical | IQI | Class I | 1982-06-10 |
| K820782 | THERATRONIC STIMULATOR | Theratronics, Inc. | IPF | Class II | 1982-06-03 |
| K821488 | ELECATH PORTAL VEIN/BILIARY DRAIN ASSM | Electro-Catheter Corp. | KNN | Class I | 1982-05-28 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.