Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 46
- Latest Decision
- 1981-02-04
Clearances · page 53 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K810222 | LIMB ORHTOSIS | Medical Design & Manufacturing Corp. | ITQ | Class I | 1981-02-04 |
| K810220 | POWERED PATIENT SYSTEM | Tri W-G, Inc. | IKZ | Class II | 1981-02-04 |
| K810111 | CELLONA PLASTER VARNISH | Secol Co. | ITG | Class I | 1981-02-04 |
| K810064 | PULSARII, HIGH VOLT. GALVANIC MUSC. STIM | Bomed Medical Mfr., Ltd. | IPF | Class II | 1981-01-26 |
| K810109 | METAL SPLINTS | Secol Co. | ILH | Class I | 1981-01-26 |
| K810024 | BONNER BRACE | Bee Ent. | IQK | Class I | 1981-01-23 |
| K810057 | GALVANATOR 725 | Avratronics Corp. | IPF | Class II | 1981-01-23 |
| K810034 | FOOT BATHS & HAND MASSAGERS | Associated Mills, Inc. | ILJ | Class II | 1981-01-15 |
| K803299 | COLD/HOT PACK | W.G. Whitney Corp. | IME | Class I | 1981-01-15 |
| K803239 | SOFTGOOD PRODUCTS AND SPLINTS | Danek Medical, Inc. | IPX | Class I | 1981-01-09 |
| K803140 | CONPHAR CRUTCH GRIPS | Conphar, Inc. | INP | Class I | 1981-01-08 |
| K803136 | CONPHAR CRUTCH TIPS | Conphar, Inc. | INP | Class I | 1981-01-08 |
| K803144 | CONPHAR CRUTCH PADS | Conphar, Inc. | INP | Class I | 1981-01-08 |
| K803139 | CONPHAR ARM SLINGS | Conphar, Inc. | ILI | Class I | 1981-01-08 |
| K803212 | BAUER & BLACK ARM SLING W/DETACH. POUCH | Bd Becton Dickinson Vacutainer Systems Preanalytic | ILI | Class I | 1981-01-08 |
| K803147 | CONPHAR ADJUSTABLE CERVICAL COLLAR | Conphar, Inc. | IQK | Class I | 1981-01-08 |
| K803137 | CONPHAR INVALID RING | Conphar, Inc. | KIC | Class I | 1981-01-08 |
| K803064 | ZIMMER ELECTRICAL MUSCLE STIMULATOR | Zimmer, Inc. | IPF | Class II | 1980-12-31 |
| K803177 | MOIST HEAT PACK | Duro-Med Ind., Inc. | IMA | Class I | 1980-12-31 |
| K802910 | PLASTIC FRACTURE CAST BRACE KNEE JOINT | Orthomedics | IQI | Class I | 1980-12-22 |
| K803063 | STRAP EASE 400 | Independent Transfer Equipment Co. | ILK | Class II | 1980-12-22 |
| K802986 | POWERED WHEELCHAIR | Vessa , Ltd. | ITI | Class II | 1980-12-22 |
| K803033 | CRUSADER HYPEREXTENSION BRACE | Orthomedics | IPY | Class I | 1980-12-22 |
| K802908 | ULNAR FRACTURE BRACE | Orthomedics | IQI | Class I | 1980-12-17 |
| K802909 | HUMERAL FRACTURE BRACE | Orthomedics | IQI | Class I | 1980-12-17 |
| K802911 | A/K SOCKET | Orthomedics | ISS | Class I | 1980-12-17 |
| K802871 | TIBIAL FRACTURE BRACE | Orthomedics | IQI | Class I | 1980-12-11 |
| K802836 | SERIES 1800 EXERCISE TREADMILL | Marquette Electronics, Inc. | IOL | Class I | 1980-12-11 |
| K802792 | CELLONA | Secol Co. | ITG | Class I | 1980-12-10 |
| K802637 | TECA MODEL-10 ELECTROMYOGRAPH | Teca, Inc. | IKN | Class II | 1980-11-26 |
| K802796 | CELLAMIN | Secol Co. | ITG | Class I | 1980-11-24 |
| K802745 | FOLDING SHOWER-COMMODE CHAIR | Winco Winfield Co., Inc. | INM | Class I | 1980-11-19 |
| K802744 | FOLDING ROLL-ABOUT CHAIR | Winco Winfield Co., Inc. | INM | Class I | 1980-11-19 |
| K802803 | CONVALESCENT RECLINER | Winfield Co., Inc. | INO | Class II | 1980-11-19 |
| K802673 | KNEE BRACE/STABILIZER | Omni Scientific, Inc. | ITQ | Class I | 1980-11-12 |
| K802642 | UTAH ARTIFICAL ARM | Motion Control, Inc. | IRE | Class I | 1980-11-12 |
| K802511 | GARELICK COMMODE | Garelick Mfg. Co. | ILS | Class I | 1980-11-12 |
| K802603 | ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION | Jefferson Industries, Inc. | KID | Class I | 1980-11-12 |
| K802442 | LOW BACK POSTURE PILLOW | Body Therapeutics, Inc. | IQK | Class I | 1980-10-31 |
| K802269 | FIGURETRIM | Colne Medical Co. , Ltd. | IPF | Class II | 1980-10-13 |
| K802335 | WHIRLPOOL BATHING UNIT-#2001 | Aqua Care Corp. | ILJ | Class II | 1980-10-10 |
| K802252 | HOT CYCLE, A CHEMICAL TYPE HOT PACK | Signal West | IMD | Class I | 1980-10-03 |
| K802107 | EGS #300 BATTERY OPER. PORTA. MUSCLE STI | Electro-Med Health Industries, Inc. | IPF | Class II | 1980-10-03 |
| K802104 | C-SPLINT | Cutter Laboratories, Inc. | IQI | Class I | 1980-09-16 |
| K802006 | TRIANGULAR BANDAGE CAT.#191 | Pollak (Intl.), Ltd. | ILI | Class I | 1980-09-16 |
| K801577 | NEUROGAR IV-EXTERNAL NEURO-MUSCLE STIM. | Inter Med Industries, Inc. | IPF | Class II | 1980-08-27 |
| K801868 | CAL-COUNT | Bayshore Systems Corp. | ISD | Class II | 1980-08-27 |
| K801593 | LEBODY BY WATER PIK | Teledyne, Inc. | ISA | Class I | 1980-08-20 |
| K801790 | INTELECT | Chattanooga Group, Inc. | IPF | Class II | 1980-08-20 |
| K801707 | BK-1499 KAY-KPLINT HAND CONE/BK-1500 | Fred Sammons, Inc. | ILH | Class I | 1980-08-20 |
| K801710 | BK-5315-01 FOAM HAND EXERCISER, SMALL | Fred Sammons, Inc. | ION | Class I | 1980-08-07 |
| K801706 | BK-1426-00-01 STONYBROOK/HI-WALL PLATE | Fred Sammons, Inc. | ILC | Class I | 1980-08-07 |
| K801714 | TRANS DISTAL JOINT FINGER EXTEN. SPLINT | Fred Sammons, Inc. | ILH | Class I | 1980-08-07 |
| K801713 | BK-6157-02 C.V.A SLING, MEDIUM&LARGE | Fred Sammons, Inc. | ILI | Class I | 1980-08-07 |
| K801708 | BK-1520-01 ECONOMY WRIST SUPPORT, CHILD | Fred Sammons, Inc. | IQI | Class I | 1980-08-07 |
| K801705 | BK-1424 INNER LIP PLATE, CERAMIC | Fred Sammons, Inc. | ILC | Class I | 1980-08-07 |
| K801709 | BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF | Fred Sammons, Inc. | KNO | Class I | 1980-08-07 |
| K801365 | KOLD WRAP | Romaine, Inc. | IME | Class I | 1980-08-07 |
| K801712 | LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC | Fred Sammons, Inc. | IPY | Class I | 1980-08-07 |
| K801788 | HUMEROUS FRACTURE BRACE, ULNA FRACTURE | Hosmer Dorrance Corp. | IQI | Class I | 1980-08-07 |
| K801776 | COLD PACK #589 | Sunbeam Corp. | IME | Class I | 1980-08-07 |
| K801743 | PLASTAZOTE SHOE | Alimed, Inc. | KNP | Class I | 1980-08-07 |
| K801701 | BAUER & BLACK RIGID WRIST BRACE | Bd Becton Dickinson Vacutainer Systems Preanalytic | IQI | Class I | 1980-08-07 |
| K801628 | RESTRAINT, PROTECTIVE | The Owenby Co. | IQK | Class I | 1980-08-07 |
| K801453 | FINGER, HAND & WRIST EXERCISER | Robert W. Slack | ION | Class I | 1980-08-04 |
| K800749 | IPOCON 7 | Ipos Luneburg | ITG | Class I | 1980-07-28 |
| K801625 | THERMOLATOR HEATING UNIT | Tru-Eze Mfg. Co., Inc. | IRQ | Class I | 1980-07-28 |
| K801626 | ARM SLING | The Owenby Co. | ILI | Class I | 1980-07-28 |
| K801643 | TRITON | Chattanooga Group, Inc. | INW | Class I | 1980-07-28 |
| K801627 | COVER, LIMB | The Owenby Co. | IPM | Class I | 1980-07-28 |
| K801531 | ARM SLING | The Owenby Co. | ILI | Class I | 1980-07-21 |
| K801557 | ROLLS ROLLITE WHEELCHAIR | Invacare Corp. | IOR | Class I | 1980-07-21 |
| K801317 | QUADRA WHEELCHAIR, QUADRA CHAIR, ETC. | Quadra Wheelchairs, Inc. | IQC | Class II | 1980-07-21 |
| K801489 | EZ ON SAFETY PONCHO | Skil-Care Corp. | KNO | Class I | 1980-07-14 |
| K801301 | GOLDEN THERMAL RHINOPLASTY CAST BANDAGE | Auric, Inc. | ILO | Class II | 1980-06-20 |
| K801250 | HYDRA TRED DC | Medichanics, Inc. | IOG | Class I | 1980-06-17 |
| K801053 | PULSED GALVANIC STIMULATOR, 450-DYNAMAX | U.S. Medical Corp. | IPF | Class II | 1980-06-04 |
| K801214 | HAMILTON TUCKAWAY DESK | Orthopedic Systems, Inc. | KNO | Class I | 1980-05-30 |
| K801217 | SKIL-CARE GEL WEDGE, FLOTATION PAD | Skil-Care Corp. | KIC | Class I | 1980-05-30 |
| K800939 | COMPUTRIM 900 | Amf, Inc. | ISD | Class II | 1980-05-28 |
| K800934 | R2 ESU CABLE-ADAPTER MODELS 160,161 | R2 Corp. | IKD | Class II | 1980-05-20 |
| K800892 | NUCLEAR STRESS TABLE (NST-1) | Technicare Corp. | ISD | Class II | 1980-05-14 |
| K801081 | DELUXE HEAT WRAP/COLD WRAP | The Gillette Company | IRT | Class II | 1980-05-14 |
| K800716 | ORTHOTIC LEG GAIT CORRECTOR DEVICE | Ipos Luneburg | ITO | Class I | 1980-05-02 |
| K800715 | OHC DYNAMIC CLUB FOOT BRACE | Ipos Luneburg | IQI | Class I | 1980-05-02 |
| K800632 | MODEL 118 PULSE MEGASON | Birtcher Corp. | IMI | Class II | 1980-05-02 |
| K800695 | BVN | Donald J. Mangus, M.D. | ITG | Class I | 1980-05-02 |
| K800484 | MOD. 3127 NEUROMUSCULAR STIMULATOR | Medtronic Vascular | IPF | Class II | 1980-05-02 |
| K800917 | TRU-COLD THERAPY PAK | Tru-Eze Mfg. Co., Inc. | IME | Class I | 1980-05-02 |
| K800958 | PERSONAL SITZ BATH KIT | The Healthcare Group Laboratories, Inc. | KTC | Class I | 1980-05-02 |
| K800752 | PRE-PADDED PLASTER/PARIS BAND/SPLINTS | Ortho-Care, Inc. | ITG | Class I | 1980-04-21 |
| K800648 | CADWELL 7200 | Cadwell Laboratories, Inc. | IKN | Class II | 1980-04-21 |
| K800251 | MT-10, ET-20 | Associated Mills, Inc. | IOG | Class I | 1980-04-02 |
| K800250 | HMB-200 | Associated Mills, Inc. | IRO | Class I | 1980-03-25 |
| K800486 | STIM-EX 201 | Th Charters, Inc. | IPF | Class II | 1980-03-19 |
| K800108 | BASHAW CERVICAL IMMOBILIZER DEVICE | Bashaw Custom Specialties, Inc. | IQK | Class I | 1980-02-29 |
| K800209 | BOOTS - OUTDOOR CARRIER FOR THE AMIGO | Amigo Sales, Inc. | ITI | Class II | 1980-02-22 |
| K800237 | FOLDING CRUTCH | Husa Folding Crutch Co., Inc. | IPR | Class I | 1980-02-22 |
| K800208 | SKIL-CARE LEG PADS | Skil-Care Corp. | KNO | Class I | 1980-02-21 |
| K792661 | TREADMILL MODEL 3060 | Cambridge Instruments, Inc. | IOL | Class I | 1980-02-19 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.