FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POINTER EXCEL
K Number: K060517
·
Decision Jun 19, 2006
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
8
Review Days
112
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
- POINTER EXCEL
- K Number
- K060517
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lhasa Oms, Inc.
- Date Received
- February 27, 2006
- Decision Date
- June 19, 2006
- 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 Lhasa Oms, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200636 | AXUS ES-5 Electro-Acupuncture Device | Feb 3, 2021 | Substantially Equivalent |
| K062003 | NEURO WAVE 6 | Sep 19, 2007 | Substantially Equivalent |
| K060508 | POINTER PLUS | Jun 19, 2006 | Substantially Equivalent |
| K061080 | IR PRO 250 | Jun 14, 2006 | Substantially Equivalent |
| K050989 | AWQ-104 | Apr 6, 2006 | Substantially Equivalent |
| K051020 | ES-160 | Feb 24, 2006 | Substantially Equivalent |
| K050435 | E-STIM II | Sep 6, 2005 | Substantially Equivalent |