POWERPRESS RECOVERY UNIT

Basic Information

• Brand Name: POWERPRESS RECOVERY UNIT
• Primary DI: 00860015634979
• Version / Model: PR1000-T
• Catalog Number: 1015
• Company Name: NEO MEDIC
• Labeler DUNS: 016404090
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-03
• Public Version: 2
• Public Version Date: 2026-04-23
• Public Version Status: Update
• Public Device Record Key: 0a7cdbb3-fbd0-4f4f-baba-b80b56bf61a3

Device Description

OTC Gradient Sequential Compression System: most firm at the bottom (foot) and gradually reduces toward the top of the garment like human body

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
IRP	Massager, Powered Inflatable Tube	Physical Medicine	890.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34489	Pneumatic massager	An pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860015634979	GS1

Premarket Submissions

Submission Number	Supplement Number
K202044	000