FDA device listing
CLX Station Anchors,Rolyan Door Anchor Stirrup,Rolyan Ergonomic Hand Exerciser,Rolyan Exercise Band,Rolyan Exercise…
FDA device listing 1716388538 · The Hygenic Company, LLC
Key facts
| Proprietary names | CLX Station Anchors,Rolyan Door Anchor Stirrup,Rolyan Ergonomic Hand Exerciser,Rolyan Exercise Band,Rolyan Exercise Tubing,Rolyan Therapy Putty,Round Roller (12" and 36"),Theraband Anchor,TheraBand Aquafins Aquatic Exercise Kit,TheraBand Closed Chain Buoyancy Disk,TheraBand Exercise Balls,TheraBand Exercise Station,TheraBand Flexbar,TheraBand Foot Roller,TheraBand Half Round Roller,TheraBand Hand… |
|---|---|
| Owner/operator | The Hygenic Company, LLC |
| Owner/operator number | 1519375 |
| Product codes | ION |
| Device names | ION - Exerciser, Non-Measuring |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5370 |
| Review panels | Physical Medicine |
| Registered establishments | THE HYGENIC COMPANY, LLC, The Hygenic Corporation |
| Establishment registrations | 1519375, 9681338 |
| FEI numbers | 1519375, 3003123739 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database