Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 35
- Latest Decision
- 1986-07-15
Clearances · page 44 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K862096 | STATIC STRENGTH TESTER | Lowcountry Orthopaedic Assoc., P.A. | IKK | Class II | 1986-07-15 |
| K861864 | MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT | I-Rep, Inc. | IMJ | Class II | 1986-07-14 |
| K862031 | HAWKINS MINI-E.B.A. | Pb Sales C/O Geller & Bozeman | IPF | Class II | 1986-07-14 |
| K862468 | RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC | Rich-Mar Corp. | IMJ | Class II | 1986-07-10 |
| K862469 | RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC | Rich-Mar Corp. | IMJ | Class II | 1986-07-10 |
| K862411 | THE RELAXARE EXERCISE AND MASSAGE UNIT | Relaxare Corp. | JFB | Class II | 1986-07-09 |
| K861136 | INTERSTIM 100 SYSTEM | Buckman Co., Inc. | IPF | Class II | 1986-07-09 |
| K862305 | ARISE, VIVRE DEBOUT | Natco Corp. | IPL | Class II | 1986-07-09 |
| K862013 | STANDING WHEELER | Engineering Mechanics, Co. | IPL | Class II | 1986-07-08 |
| K861832 | RICH-MAR SPINA-MOBILIZOR | Rich-Mar Corp. | ITH | Class II | 1986-06-27 |
| K861796 | FITTRONIC | Corleone Intl. Traders, Inc. | IPF | Class II | 1986-06-25 |
| K862022 | LIC-ORTHION MULTI-THERAPY TREATMENT TABLE | Lic-Orthion | JFB | Class II | 1986-06-19 |
| K861554 | PORT-A-TRAC | Port-A-Trac Co. | JFB | Class II | 1986-06-19 |
| K860315 | NEUROTECH-16 PROGRAM SYSTEM CONTROLLER MODEL 280 | Neurotech, Inc. | IPF | Class II | 1986-06-17 |
| K860314 | NEUROTECH-4 PROGRAM NEUROMUSCULAR STIMULATOR 281 | Neurotech, Inc. | IPF | Class II | 1986-06-17 |
| K862041 | WM10, WM20, WM30 POWER MASSAGER | Associated Mills, Inc. | ISA | Class I | 1986-06-17 |
| K854485 | RICH-MAR IF 200 | Rich-Mar Corp. | IPF | Class II | 1986-06-10 |
| K861739 | TEC PORTAMAX H.V. PULSED GALVANIC STIMULATOR | J.A. Preston Corp. | IPF | Class II | 1986-06-09 |
| K861986 | LIDO BACK | Loredan Biomedical, Inc. | IKK | Class II | 1986-06-02 |
| K861327 | ROHO HEEL PAD | Roho, Inc. | KIC | Class I | 1986-06-02 |
| K861943 | PCI CUSTOM DESIGN SERIES | Poston & Cole Intl. | IQC | Class II | 1986-05-30 |
| K860619 | ES 180-DCM MUSCLE STIMULATOR | Promatek | IPF | Class II | 1986-05-30 |
| K861247 | CURAMED 402 DIATHERMY UNIT | Henley Intl. | IMJ | Class II | 1986-05-30 |
| K861248 | CURAPULS 419 DIATHERMY UNIT | Henley Intl. | IMJ | Class II | 1986-05-30 |
| K861622 | SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER | Orthopedic Systems, Inc. | IKK | Class II | 1986-05-27 |
| K861729 | SPRINT (POWER DRIVE WHEELCHAIR) | Everest & Jennings, Inc. | ITI | Class II | 1986-05-27 |
| K861632 | SIMS CHAIR | Twin City Surgical, Inc. | IKK | Class II | 1986-05-27 |
| K861834 | THERACUSHION MODEL 1000 | General Physiotherapy, Inc. | ISA | Class I | 1986-05-27 |
| K861344 | R1124 & R1686 PARAFFIN | Tri W-G, Inc. | IMC | Class II | 1986-05-27 |
| K861755 | SHS CUSHION/WHEELCHAIR | Special Health Systems, Ltd. | KNN | Class I | 1986-05-23 |
| K861751 | THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS | Special Health Systems, Ltd. | KNN | Class I | 1986-05-23 |
| K861754 | KINESETHETIC SEATING SYSTEM/WHEELCHAIR | Special Health Systems, Ltd. | KNN | Class I | 1986-05-23 |
| K861260 | PEDABAROGRAPH | Biokinetics, Inc. | JFC | Class I | 1986-05-02 |
| K861348 | R1361 & R1372 MEASURED EXERCISE EQUIPMENT | Tri W-G, Inc. | ISD | Class II | 1986-05-02 |
| K861340 | R1750 AND R1424 POWERED HEATING UNITS | Tri W-G, Inc. | IRQ | Class I | 1986-05-02 |
| K860758 | VACO SUCTION ELECTRODE UNIT | Zimmer Elektromedizin GmbH | IPF | Class II | 1986-05-02 |
| K861347 | R1596 POWERED EXERCISE EQUIPMENT | Tri W-G, Inc. | IOL | Class I | 1986-05-02 |
| K861346 | R1363 PARAFFIN | Tri W-G, Inc. | IMC | Class II | 1986-05-02 |
| K861352 | R1698,R1701,R1215,R1700 & R860 POWERED TABLES | Tri W-G, Inc. | INQ | Class I | 1986-05-02 |
| K861350 | R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213 | Tri W-G, Inc. | INW | Class I | 1986-05-02 |
| K861206 | NAUTILUS LEG EXTENSION TESTING & REHABILITATION | Nautilus Sports/Medical Industries, Inc. | IKK | Class II | 1986-04-18 |
| K861218 | AQUA ARK, IMMERSION HYDROBATH | Aqua Ark, Inc. | ILJ | Class II | 1986-04-18 |
| K860821 | BIODEX SYSTEM | Biodex Corp. | IKK | Class II | 1986-04-18 |
| K861383 | SOLEX THERAPEUTIC PAD | Intl. Diathermics Research, Inc. | IRT | Class II | 1986-04-18 |
| K860632 | EBI HAND MASSAGING PUMP (HMP) | Electro-Biology, Inc. | IRP | Class II | 1986-04-18 |
| K854710 | BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID | Reloke Co. | KNN | Class I | 1986-04-16 |
| K860099 | MEDCO-SONIC NQ-2000 | Medco Products, Co., Inc. | IMI | Class II | 1986-04-09 |
| K855086 | KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE | Kempf Co. | ITI | Class II | 1986-04-04 |
| K853154 | HV-4 | Robert Bosch Corp. | IPF | Class II | 1986-03-28 |
| K860107 | SYS*STIM 206 (MODEL-ME 206) | Mettler Electronics Corp. | IPF | Class II | 1986-03-28 |
| K855249 | MIDIFICATION SYS*STIM 207 (MODEL-ME207) | Mettler Electronics Corp. | IPF | Class II | 1986-03-28 |
| K860714 | ACE AIM - CPM HAND UNIT | Buckman Co., Inc. | JFA | Class I | 1986-03-27 |
| K860082 | THERMOTRON 918 | Medical Microwave Research Corp. | IOA | Class II | 1986-03-27 |
| K854801 | MS-189 MUSCLE STIMULATOR | Electro Med Supply, Inc. | IPF | Class II | 1986-03-27 |
| K854461 | HANDI-MOVE | T.F. Herceg, Inc. | ILK | Class II | 1986-03-14 |
| K855072 | MAXIMUS CUSHION | Jay Medical, Ltd. | KIC | Class I | 1986-03-10 |
| K860521 | STANDARD WHEELCHAIRS | Formotion, Inc. | IOR | Class I | 1986-03-10 |
| K854720 | NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. | Nemectron Medical, Inc. | IPF | Class II | 1986-03-10 |
| K860444 | MAZING HEAT DISPOSABLE WARM PACK | Leebryan Intl. | IMD | Class I | 1986-02-27 |
| K854775 | EMPI MODEL 730 NMS | Empi | IPF | Class II | 1986-02-12 |
| K854774 | EMPI MODEL 720 NMS | Empi | IPF | Class II | 1986-02-12 |
| K854354 | THE BLEDSOE PASSIVE MOTION EXERCISER | Medical Technology and Innovations, Inc. | BXB | Class I | 1986-02-06 |
| K860227 | POWERED TRACTION EQUIPMENT | R. P. Hood, Inc. | ITH | Class II | 1986-02-06 |
| K860159 | THUMPER (VIBRATOR/MASSAGER) | Wellness Innovations Corp. | IRO | Class I | 1986-02-06 |
| K854151 | HOMECARE CLINICS INFRAHEAT #230 | Nelkin/Piper Intl. | ILY | Class II | 1986-01-30 |
| K854164 | CRUISER | Invacare Corp. | ITI | Class II | 1986-01-13 |
| K860072 | JUERGENS SELF RELIANT WHEELCHAIR | E.H. Juergens, Inc. | IOR | Class I | 1986-01-13 |
| K853918 | THE SPORTSTER (ELECTRIFIED WHEELCHAIR) | Amigo Sales, Inc. | INI | Class II | 1986-01-13 |
| K855181 | COMFORTEX WHEELCHAIR CUSHION | Comfortex, Inc. | KNN | Class I | 1986-01-13 |
| K854635 | ELECTRA CHIROPRACT/EQUIP TABLE ELECTRA I&STATIONAR | Electra Equipment , Ltd. | INQ | Class I | 1986-01-03 |
| K854861 | SETMA HYGIA BATH MODEL ST 7200 | Setma, Inc. | ILJ | Class II | 1986-01-03 |
| K853710 | THERACUSHION | General Physiotherapy, Inc. | ISA | Class I | 1986-01-03 |
| K854947 | REHABILITATION TABLES | I-Rep, Inc. | INQ | Class I | 1986-01-03 |
| K850495 | AKUFON THERAPEUTIC MASSAGER | Jansson A/S | IRO | Class I | 1986-01-03 |
| K854051 | MODULAR POWER BASE | Everest & Jennings, Inc. | ITI | Class II | 1985-12-27 |
| K853804 | VICON (MODIFICATION) | Oxford Metrics, Inc. | IKN | Class II | 1985-12-27 |
| K854153 | MARATHON POWER DRIVE-WHEELCHAIR | Everest & Jennings, Inc. | ITI | Class II | 1985-12-27 |
| K854147 | BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL | Battle Creek Equipment Co. | IOL | Class I | 1985-12-27 |
| K853635 | SUBDERM TM | General Medical Co. | EGJ | Class II | 1985-12-20 |
| K854148 | BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL | Battle Creek Equipment Co. | IOL | Class I | 1985-12-17 |
| K854497 | VOYAGEUR, BUTTERFLY ONE, CADET LAURENTIAN, HORIZON | Canadian Wheelchair | IOR | Class I | 1985-12-02 |
| K853750 | SYS*STIM 207 MODEL ME 207 | Mettler Electronics Corp. | IPF | Class II | 1985-11-26 |
| K852637 | THERMO TRIM | Suntec Health & Fitness Group, Inc. | IRT | Class II | 1985-11-20 |
| K853766 | ALPHA SUPER KART | Alpha Unlimited, Inc. | INI | Class II | 1985-11-20 |
| K854283 | CAMBRIDGE MODEL XT1000 | Cambridge Medical Instruments, Inc. | IOL | Class I | 1985-11-13 |
| K854263 | SETMA FHT, MODEL ST 8130 | Setma, Inc. | ILJ | Class II | 1985-11-13 |
| K853424 | THE MOVER | Invacare Corp. | IOR | Class I | 1985-11-05 |
| K852812 | COMFORT + LIFT | Invacare Corp. | INO | Class II | 1985-11-05 |
| K853649 | POWER DRIVE WHEELCHAIR | Everest & Jennings, Inc. | ITI | Class II | 1985-11-05 |
| K853297 | MULTIPLE | Sun Air, Inc. | ISA | Class I | 1985-11-05 |
| K853163 | SETMA VHT | Setma, Inc. | ILJ | Class II | 1985-11-05 |
| K853595 | VESSA TREKKA | Vessa , Ltd. | ITI | Class II | 1985-11-01 |
| K853973 | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER | Wescor, Inc. | KTB | Class II | 1985-10-16 |
| K852977 | KNEE MACHINE | Kaiser Medical | BXB | Class I | 1985-10-16 |
| K852381 | FALCON (POWERED WHEELCHAIR) | Venturego, Inc. | ITI | Class II | 1985-10-07 |
| K852166 | THERMO SHORTWAVE DIATHERMY | Zimmer Elektromedizin GmbH | IMJ | Class II | 1985-09-30 |
| K852651 | THERA-TRONIC THERAPEUTIC TREATMENT TABLE | Rwm Co. | INQ | Class I | 1985-09-30 |
| K853148 | HOT OR HEAT PACK | Matrix Intl. | IMD | Class I | 1985-09-25 |
| K852864 | GENTLE LIFT-RECLINER CHAIR | Pride Health Care Equipment | INO | Class II | 1985-09-24 |
| K853593 | VESSA TRAVVLA | Vessa , Ltd. | ITI | Class II | 1985-09-24 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.