FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
K Number: K153559
·
Decision Aug 26, 2016
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
54
Applicant Total
1
Review Days
256
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
- K Number
- K153559
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Accelerated Care Plus (Acp)
- Date Received
- December 14, 2015
- Decision Date
- August 26, 2016
- Product Code
- IMG
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IMG), ordered by most recent decision date.
Ultrasound Therapy Workstation (XMS-UET2)
FDA 510(k)
FDA Class 2
·Physical Medicine
ComboRehab
FDA 510(k)
FDA Class 2
·Physical Medicine
BTL-4000
FDA 510(k)
FDA Class 2
·Physical Medicine
SONICSTIMU COMBO THERAPEUTIC DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
FDA 510(k)
FDA Class 2
·Physical Medicine
FUTURA
FDA 510(k)
FDA Class 2
·Physical Medicine