Revive RVT30

Basic Information

• Brand Name: Revive RVT30
• Primary DI: EJKP100003960B0
• Version / Model: JK 98 / RV 30-0 VBR E
• Company Name: JK-Products GmbH
• Labeler DUNS: 316232073
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-01
• Public Version: 1
• Public Version Date: 2023-12-11
• Public Version Status: New
• Public Device Record Key: b5bdc6c5-49f8-495d-b874-6416a55b0868

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BXB	Exerciser, Powered	Physical Medicine	890.5380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58270	Vibration platform exerciser, stationary	A non-mobile, mains electricity (AC-powered) device designed to generate vertical high-intensity vibrations intended to traverse the body [whole body vibration (WBV)] and cause involuntary muscle contractions to help strengthen/tone muscles and tendons, increase blood flow and joint range of motion, and provide body massage and other health benefits. It consists of a motorized platform/plate, typically with a pole with a digital display/handrails, upon which the user can stand, sit, lay, or apply a specific body part. It may include accessories for specific training (e.g., resistance) and may be used in the home and athletic/clinical settings for rehabilitation or weight loss applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EJKP100003960B0	HIBCC