Product code ILO— Physical Medicine
EBICE
- Classification name
- Pack, Hot Or Cold, Water Circulating
- Device class
- Class 2
- Regulation
- 21 CFR 890.5720
- Advisory panel
- Physical Medicine
- Total cleared
- 93
- First cleared
- Most recent
Market context for product code ILO
FDA has cleared devices under product code ILO between 1976 and 2022, filed by 53 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2009
- 2008
- 2007
- 2004
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
Top applicants under product code ILO
Recent clearances under product code ILO
- K213097 — Armory Motion
- K083008 — COOLSKIN
- K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
- K072152 — JUNIPER CLN1 DERMAL COOLING DEVICE
- K070402 — MODIFICATION TO POLAR CARE 500
- K040317 — IVC SYSTEM
- K973023 — INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
- K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP
- K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK
- K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY
- K964710 — BLEDSOE COLD CONTROL
- K970533 — MODEL 1100 COLD THERAPY DEVICE
- K962983 — STERILE SOFT-TEMP
- K964006 — INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
- K964057 — INCARE HOT/ICE SYSTEM SHOULDER BLANKET
- K963596 — POLAR CARE 300
- K962537 — INCARE HOT/ICE LITE MACHINE
- K961621 — THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM
- K961425 — BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS
- K963261 — EBI THERMAL THERAPY SYSTEM
- K961855 — POLAR CARE (MODEL 500/50000)
- K955529 — CRYTRON SYSTEM
- K955326 — SPORTS CONTRAST THERAPY SYSTEM ST 7000
- K955057 — MODEL 1100 COLD THERAPY DEVICE
- K954095 — MEDICOOL (MODIFICATON)
- K945853 — THERMOTEK H-300
- K953532 — EBICE
- K950395 — THERMOCOOL SYSTEM
- K950711 — T-350 THERAPEUTIC COOLING MACHINE
- K945468 — T-300 COOLER
- K943497 — CONTRAST 7000 THERAPY SYSTEM
- K945467 — BABYTHERM 8000 WB
- K934262 — HPRH HOSPITAL PATIENT RADIANT HEATER
- K945399 — DELTA THERM COLD THERAPY SYSTEM
- K942882 — TOTALLY COOL(TM) TC-2
- K943844 — TOTALLY COOL(TM) TC-1
- K944447 — COOL/HEAT THERAPY APPLICATOR
- K945067 — EBICE
- K944971 — INCARE HOT/ICE COLD THERAPY COOLER
- K935841 — DR KOOL
- K936143 — ISOCOMFORTER
- K940429 — ORTHO TECH CRYOLOGIC SYSTEM
- K940858 — THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)
- K940160 — TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
- K930918 — HYDROT
- K931203 — COOL-AID
- K931843 — HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
- K930634 — SUR FLO THERMAL THERAPY PADS
- K926151 — LSI6000 THERMAL THERAPY SYSTEM
- K925677 — AUTOCHILL ACCESSORY KIT
- K923643 — MEDICOOL
- K921540 — COOLING/HEATING THERAPY DEVICE
- K920581 — POLAR PAD (STERILE)
- K915196 — INCARE HOT/ICE SYSTEM 3
- K913026 — TTU-100THERMAL THERAPY UNIT
- K914434 — POLAR PADS
- K913729 — POLAR PUMP, MODEL 500
- K914182 — GOLDEN THERMAL(R)
- K912722 — HYPER-K HEAT SYSTEM
- K911943 — CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM
- K910061 — K-MODULE II HEAT THERAPY SYSTEM
- K904998 — THE BODY COOLER SYSTEM
- K902268 — PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.
- K902269 — ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY
- K900356 — THERMOAIRE SPLINT (TM) (TAS)
- K891091 — TEMPTEK T-1000 THERAPEUTIC COOLING UNIT
- K900355 — MARK VII THERMOREGULATION ASSIST SYSTEM
- K891603 — BODY COOLER OR COOLVEST OR ALPHA BODY COOLER
- K893706 — COLD/HOT FLUID RADIATION PAD NEUTECH
- K891092 — TEMPTEK 5010 THERMAL COOLING BLANKET
- K890852 — AQUA-BLANKET HYPER/HYPOHERMIA BLANKET
- K890853 — AQUA-PAD FOR MOIST OR DRY HEAT THERAPY
- K891151 — COOL 'N HEAT MACHINE
- K891152 — GRAND COOLING MACHINE
- K884255 — CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
- K883681 — DAS SPORT PUMP(TM)
- K882310 — DUAL-TEMP(TM) COOLING/WARMING UNIT
- K871962 — HOT/ICE DUAL FUNCTION EQUIPMENT
- K871963 — HOT/ICE DISPOSABLE BLANKET
- K852495 — CAST-TECH CO. COOLING SYSTEM
- K843146 — MICRO-TEMP PUMPS & MICRO-TEMP PADS
- K833564 — HOT/ICE DISPOSABLE BLANKET
- K832819 — MUL-T-PAD
- K832820 — MUL-T-BLANKET
- K830757 — HOT/ICE
- K801301 — GOLDEN THERMAL RHINOPLASTY CAST BANDAGE
- K791162 — GELSKIN
- K780452 — THERA-PAK
- K761254 — BAND-AGE ICE-BANDAGE
- K760910 — DISPOSABLE K-PADS
- K760782 — TECNOL PATIENT USE ICE PACK
- K760804 — T-PUMP, TEMPERATURE - THERAPY PUMP
- K760527 — T-PAD
Data sourced from openFDA. This site is unofficial and independent of the FDA.