FDA.reportPublic FDA data

RP Lite 760R

Primary DI
07290105871497
Brand
RP Lite 760R
Company
MEGO afek Agricultural Cooperative Society Ltd
Model
760R
Catalog number
L10007AR
Device description
RP Lite® is a massage system intended for use by people in good health.As noted above, RP Lite® simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.
Published
2019-12-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163280000RP Lite 760RMego Afek AC , Ltd.2017-01-27IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290105871497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290105871497072901058714977290105871497

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression system inflatorAn electrically-powered device intended to be used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit applied to the extremities with the necessary pressure to promote venous blood flow through its sequential inflation and deflation. Also referred to as a pump, it typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8557327867info@rpsports.com

Regulatory Flags#

DUNS number
514658082
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290105871213Ballancer 505 1201-AC USA1201ACL10505CBA2019-12-24
07290105871480Nano Press 760A (US)760AL10007A2-US2019-12-24
07290105878670Ballancer 505 V2 1201-AC1201ACL10004C6-US2019-12-24
07290105878939Optimal 1201AD Optimized for Pod1201ADL10003C7P2019-12-24
07290105878946Lympha Press Optimal 1201AD1201ADL10003C7U2019-12-24
07290105879042Phlebo Press DVT 760D (US)760DL10007D42019-12-24
07290105879110Lympha Press Optimal Plus(US) BT912L10008C2-US2019-12-24
07290105879165Ballancer Gold (US)12122019-12-24
07290105879325RPX 737R Device 2020737RL10005H2R-US2019-12-24
07290105879332PCD-51 731A (US) - White731AL10015G12019-12-24
07290105879431PCD-52™ 737A (US) White737AL10015H12019-12-24
07290105870155201Max Calibrated device201MaxL10000632019-12-24
07290105875402Calf&Foot L NRC-DVTDVT C&F L SPUL4ZD23302023-02-12
07290105872685#4 Adult Boot XL (4 cells)4 Boot XLL41204402019-12-24
07290105872692Adult Boot # 1A RC-FLSBoot 1AL41211102019-12-24
07290105872708Adult boot No. 2A RC-FLSBoot 2AL41212102019-12-24
07290105872791FL sleeve 2-75 RC-FLSFL 2-75L41320752019-12-24
07290105872807FL sleeve 2-85 RC-FLSFL 2-85L41320852019-12-24
07290105872852FL sleeve 3-85 RC-FLSFL 3-85L41330852019-12-24
07290105872869FL sleeve 3-95 RC-FLSFL 3-95L41330952019-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812120004895Game Ready* SystemAvanos Medical, Inc.IRP2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.IRP2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.IRP2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.IRP2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.IRP2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.IRP2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.IRP2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005366Game Ready* Hip/Groin Sleeve, RightAvanos Medical, Inc.IRP2026-07-31
00812120005373Game Ready* Hip/Groin Sleeve, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005380Game Ready* Hand/Wrist SleeveAvanos Medical, Inc.IRP2026-07-31