FDA Registration
Active
🇺🇸 United States
G5® Lumen EssenceTM with accessories
Reg #: 1937060
·
FEI: 1000147357
·
Expires 2025
Products
1
Proprietary Names
37
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GENERAL PHYSIOTHERAPY II LLC
- Registration Number
- 1937060
- FEI Number
- 1000147357
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3683 New Town Blvd
- City
- Saint Charles
- State
- MO
- ZIP
- 63301
- Country
- US
Regulatory Submissions
- 510(k) Number
- K852944
Owner / Operator
- Firm Name
- General Physiotherapy II LLC
- Operator Number
- 10092333
- Address
- 3683 NEW TOWN BLVD
- City
- Saint Charles
- State
- MO
- Postal Code
- 63301
- Country
- US
- Correspondent
- Zachary Silverstein
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2024-12-24 |
Proprietary Names
G5® Lumen EssenceTM with accessories
G5® Contour® with accessories
G5®Vibramatic® with accessories
G5® GX-99® with accessories
Disposable Covers Model
209, 210, 212, 214, 215, 216, 217, 222, 223,225,
G5® GK-® with accessories
G5® Multimatic® with accessories
227,228,229, 230, 242, 250, 251, 252, 253, 331
MD-2000 with accessories
G5® Professional Therapy Package
G5® FreedomTM Airway Clearance System
Massager/Percussor Applicators & Accessories Model
G5® Cellutec® with accessories
G5® Vibracare® & G5® Personal Masseur Carry Case
G5® Flimm-Fighter® with accessories
G5® ALCTM with accessories
G5® Pro. Portable Treatment Package
G5® Palm PowerTM with accessories
G5® GeminiTM with accessories
G5® Disposable Applicator Covers
G5® Digital K-3TM with accessories
G5® GBMTM with accessories
G5® Therassist® with accessories
G5® Vari-Tilt® with accessories
Self Application System
G5® Spa Package
Accessory Tray
G5® Quick-Change Applicators
G5® Fleximatic®/Workout Masseur w/accessories
Body Postioner Model
Mobile Caster Stand
G5® Respiratory Therapy Package
Pre-Packaged Applicator Package
G5® PlusTM with accessories
Re-Usable Applicator Covers (No. 234, 235, 236, 237)
G5® PhoenixTM with accessories
Establishment Types
Manufacture Medical Device