FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
K Number: K082011
·
Decision Nov 28, 2008
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
32
Review Days
136
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
- MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
- K Number
- K082011
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Medical Research, Ltd.
- Date Received
- July 15, 2008
- Decision Date
- November 28, 2008
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZJ), ordered by most recent decision date.
STIMPOD NMS460 Nerve Stimulator
FDA 510(k)
FDA Class 2
·Neurology
actiTENS mini
FDA 510(k)
FDA Class 2
·Neurology
CP Relief Wand Rx - TENS/NMES
FDA 510(k)
FDA Class 2
·Neurology
Unipro (K-UNIPRO-US)
FDA 510(k)
FDA Class 2
·Neurology
TENSWave
FDA 510(k)
FDA Class 2
·Neurology
Electrical Neuromuscular Stimulator, Cure Trio
FDA 510(k)
FDA Class 2
·Neurology
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 |
| K180688 | SLENDERTONE CoreFit Abs 8, Type 734 | Oct 25, 2018 | Substantially Equivalent |
| 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 |