FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASCEND
K Number: K140333
·
Decision Jul 3, 2014
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
18
Review Days
143
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
- ASCEND
- K Number
- K140333
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurometrix, Inc.
- Date Received
- February 10, 2014
- Decision Date
- July 3, 2014
- Product Code
- NUH
- 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 |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NUH), ordered by most recent decision date.
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
FDA 510(k)
FDA Class 2
·Neurology
TENS/EMS device (GUSE01)
FDA 510(k)
FDA Class 2
·Neurology
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
FDA 510(k)
FDA Class 2
·Neurology
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
FDA 510(k)
FDA Class 2
·Neurology
VEINOPLUS Back
FDA 510(k)
FDA Class 2
·Neurology
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Neurometrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN210046 | Quell-FM | May 18, 2022 | Unknown |
| K152954 | Quell | Jan 5, 2016 | Substantially Equivalent |
| K140586 | ASCEND ELECTRODE | Nov 17, 2014 | Substantially Equivalent |
| K130919 | SENSUS | Jul 2, 2013 | Substantially Equivalent |
| K121816 | SENSUS ELECTRODE | Nov 26, 2012 | Substantially Equivalent |
| K121184 | SENSUS | Aug 2, 2012 | Substantially Equivalent |
| K091155 | ASCEND | Sep 3, 2009 | Substantially Equivalent |
| K083322 | NEUROMETRIX BIOAMPLIFIER | May 27, 2009 | Substantially Equivalent |
| K083818 | UNIVERSAL ELECTRODES | Jan 21, 2009 | Substantially Equivalent |
| K081871 | UNIVERSAL ELECTRODES | Sep 29, 2008 | Substantially Equivalent |