FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
SLENDERTONE CoreFit Abs 8, Type 734
K Number: K180688
·
Decision Oct 25, 2018
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
32
Review Days
224
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
- SLENDERTONE CoreFit Abs 8, Type 734
- K Number
- K180688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Medical Research, Ltd.
- Date Received
- March 15, 2018
- Decision Date
- October 25, 2018
- Product Code
- NGX
- 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 |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NGX), ordered by most recent decision date.
Diacore
FDA 510(k)
FDA Class 2
·Physical Medicine
Zionic Pro Max (EMS)
FDA 510(k)
FDA Class 2
·Physical Medicine
CoolTone
FDA 510(k)
FDA Class 2
·Physical Medicine
Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)
FDA 510(k)
FDA Class 2
·Physical Medicine
Motive Muscle Stimulator for Lower Back (OT01-1003)
FDA 510(k)
FDA Class 2
·Physical Medicine
truFlex
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Bio-Medical Research, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K203513 | SLENDERTONE Evolve Abs, Type 735 | Feb 10, 2021 | Substantially Equivalent |
| DEN170049 | Innovo | Nov 6, 2018 | Unknown |
| K161974 | SLENDERTONE® Connect Abs, Type 570 | Nov 1, 2016 | Substantially Equivalent |
| K151903 | Slendertone connect Abs | Nov 6, 2015 | Substantially Equivalent |
| K112934 | NEUROTECH RECOVERY | Jan 20, 2012 | Substantially Equivalent |
| K112258 | NEUROTECH PLUS | Jan 9, 2012 | Substantially Equivalent |
| K103031 | BMR FACE | Nov 10, 2011 | Substantially Equivalent |
| K110350 | KNEEHAB XP | Aug 3, 2011 | Substantially Equivalent |
| K102614 | AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 | Jun 3, 2011 | Substantially Equivalent |
| K100556 | SLENDERTONE FLEX MAX, MODEL 517 US | Aug 2, 2010 | Substantially Equivalent |