BEUDAMED
    Product Code: IRP FDA class 2 21 CFR 890.5650

    Massager, Powered Inflatable Tube

    Physical Medicine

    A powered inflatable tube massager is a device that uses air-filled inflatable tubes or bladders, powered by a pump, to apply cyclical pressure and massage to body areas for therapeutic purposes such as improving circulation and reducing muscle tension. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IRP, regulated under 21 CFR 890.5650, within the Physical Medicine medical specialty. This device is eligible for third party 510(k) review.

    View on FDA
    510(k)s
    153
    FEI Numbers
    95
    Registration Numbers
    95
    Unique Applicants
    95
    Years Active
    48

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    Basic Information

    Product Code
    IRP
    Device Class
    FDA class 2
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 153 510(k) clearances via K numbers.

    K Number Device Name
    K253919 Cryo And Thermo Therapy System
    K252396 Cryo Sport 2.0 (AVA 501)
    K254200 Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)
    K253064 Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)
    K252386 Hot and Cold Compression System (A02-C-032)
    K253076 Cryopush Cold Compression Device (A02-P-001)
    K251622 Hand Massager (SM004D)
    K251662 Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507)
    K251531 AIR COMPRESSION BOOTS 1018195,1018196
    K253150 Cryon-X Cold Compression
    K251905 Normatec Elite Hip
    K251623 Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)
    K250244 Compression Therapy Device (LGT-2210DS)
    K242615 Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)
    K242754 ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)
    K250046 Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
    K242140 Air Compression Leg Massager (K-705)
    K243206 Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
    K243572 Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La
    K243791 Air Pressure Therapy System
    K243177 SACS PRO
    K232965 Leg Massager (Models:RP-ALM070H, RP-ALM071H)
    K243320 Air Pressure Therapy System (VU-IPC04B)
    K242940 Xrecovery (XR-001)
    K241446 Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)
    K240373 Air compression Leg Massager (MM0520, MM0521, MM0522)
    K241256 JetBoots PRO Plus
    K240981 Air compression leg massager
    K233238 Air Pressure Therapy System (Model:VU-IPC4M)
    K240986 Cold Compression
    K240122 Normatec Elite
    K230524 Cold Compression Wrap Pro
    K223729 FLOWpresso
    K233536 Air Compression Recovery System
    K223541 Cold/Hot Compression
    K230500 Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)
    K231912 Therm-X
    K231437 LF900
    K230385 Ballancer Platinum (1222)
    K222991 Air Compression Leg Massager (model: EMK-701)
    K223464 Leg and Foot Air Wave Pressure Therapy Device
    K222136 Cryo-Thermo Compression Device (FGK002)
    K222924 Leg Massager RF-ALM070
    K222949 Air Compression Leg Massager (Model: LY-670D)
    K221862 YY-A02-B Overlapped Compression Therapy
    K222669 Cryopush Cold Compression Device
    K223164 Aquilo Sports CCT1500 System
    K222206 Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
    K201730 Powered Inflatable Tube Massager - SLIM UP DRAIN
    K221666 Normatec Go
    K213745 Air Compression Therapy Device, model: ST-502
    K211850 Air Compression Leg Massager (model: FE-7204B)
    K220217 Normatec 3
    K212935 Air Pressure Foot Massager
    K213533 Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
    K212713 Air compression leg massager HY-1117A
    K212169 Air compression therapy system FO3002
    K213000 Air Compression Massager (Model LF-FT003)
    K211745 RecoveryAir PRO
    K211283 Compressible Limb and Circulation Therapy System, Model POWER-Q2300
    K212491 Air Relax Pro Model AR-4.0
    K202395 SP-1000, SP-2000
    K210913 V12 PRO
    K203498 LX9max
    K203019 LF900
    K201935 Air Pressure Therapy System
    K210281 Fist Assist Devices Model FA-1
    K211460 Air Relax Plus Model AR-3.0
    K210967 Air Pressure Therapy System: VU-IPC06
    K201982 Air compression therapy system FO-3001; Air compression therapy system FO-3008
    K200660 Compressible Limb and Circulation Therapy System
    K202693 NeoWave Pain Relief and Recovery System, Model# T16-2020
    K191441 Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
    K210240 Air Compression Therapy Device, model HW6007
    K193079 ICE COMPRESSION FIRST, DUO, & MOOVE Systems
    K203552 Rapid Reboot
    K201694 Air Compression Therapy Device
    K202044 Powerpress Recovery Unit
    K201645 Massage Compression Boots
    K200351 PlasmaFlight
    K192466 Air Compression Therapy System
    K193354 Air Compression Therapy Device
    K192358 Pressure Therapy System PT1003
    K193550 Therm-X
    K192607 LiteWalk
    K192114 Game Ready GRPro 2.1 System
    K191862 Compression Therapy Device Model LGT-2200SP
    K192252 ProPerformance Recovery System
    K173158 Air Relax
    K190493 Recovery Pump, 737R (RPX)
    K190854 Therm-X
    K190015 Ballancer Gold, 1212
    K183702 Polar Care Wave
    K181409 Pressure Therapy System PT1003
    K183169 Pulse 2.0, Pulse Pro 2.0
    K182668 Rapid Reboot Compression Therapy System
    K181149 Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
    K171685 Med4 Elite
    K161907 Pressure Therapy System
    K163280 RP Lite 760R
    K160178 Lympha-Flow(LF1200)
    K160608 NormaTec Pulse and NormaTec Pulse Pro
    K150269 Ballancer 505 System, Model 1201-AC
    K150033 Air Compressible Limb Therapy System
    K143197 Nice1
    K140519 RECOVERY PUMP 737R
    K133483 PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
    K130385 COMPRESSIBLE LIMB SLEEVE SYSTEM
    K122112 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
    K123829 PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
    K122154 POWERPLAY MUSCLE MASSAGER
    K120166 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
    K113275 COMPRESSIBLE LIMB THERAPY SYSTEM
    K112441 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
    K112890 NORMATEC MVP
    K112479 DSJ MASSAGER
    K102320 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)
    K102319 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008
    K100656 COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)
    K092435 VERSEO AIR PRESSURE MASSAGER
    K080134 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)
    K071596 POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
    K072620 GAME READY CLASSIC SYSTEM, MODEL 550550
    K071050 GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM
    K040905 WELLNESS/JOLIVETE
    K032505 AIR PRESS MASSAGER
    K030437 RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM
    K013061 BIOTOUCH MASSAGE THERAPY SYSTEM
    K003909 PROACT 1
    K000655 PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE
    K994057 SLENDAIR 4000 COMPRESSION SYSTEM
    K991921 INTERMITTENT COMPRESSION BOOT FOR OTC
    K974395 ATLANT'S
    K964957 INTERMITTENT COMPRESSOR SYSTEM
    K961426 BIO BOOST
    K953516 MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP
    K951769 CRYOPRESS
    K915638 TALLEY TM200 INTERMTTENT COMPRESSION UNIT
    K915637 TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST.
    K915092 TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST
    K914774 MULTIPULSE SEQUENTIAL COMPRESSION UNIT
    K914142 HEMO-PULSE 2000
    K912004 SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS
    K901022 POWERED INFLATABLE TUBE MASSAGER, SPORT-MED
    K893950 VENTIPRESS 24 AND 14 PRESSURE VENTILATOR
    K874688 FLOWTRON AC200/2
    K860632 EBI HAND MASSAGING PUMP (HMP)
    K852264 EBI FOOT MASSAGING PUMP
    K834507 HYDROPULSE(GROSSAN);INFLAT TUBE MASS
    K832920 INTERMITTENT COMPRESSION PUMPS
    K821920 I.C.E. BOX
    K781964 COMPRESSION DEVICES, LIMB
    K780710 AIR MASSAGE SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 95 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 95 registration numbers. Click on an entry to view related FDA registrations.