FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EA STIMULATOR
K Number: K080221
·
Decision Sep 9, 2008
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
12
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
- EA STIMULATOR
- K Number
- K080221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Helio Medical Supplies, Inc.
- Date Received
- January 29, 2008
- Decision Date
- September 9, 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 Helio Medical Supplies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072778 | BRIO ACUPUNCTURE NEEDLES | Nov 19, 2007 | Substantially Equivalent |
| K062448 | LYRA ACUPUNCTURE NEEDLES | Sep 20, 2006 | Substantially Equivalent |
| K052723 | SEVEN STAR NEEDLE | Jan 13, 2006 | Substantially Equivalent |
| K050295 | PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES | Mar 25, 2005 | Substantially Equivalent |
| K043277 | C&G ACUPUNCTURE NEEDLE | Feb 8, 2005 | Substantially Equivalent |
| K024207 | VINCO BRAND ACUPUNCTURE NEEDLE | Apr 14, 2003 | Substantially Equivalent |
| K012583 | ACUGLIDE BRAND ACUPUNCTURE NEEDLES | Dec 11, 2001 | Substantially Equivalent |
| K991507 | KANGNIAN BRAND ACUPUNCTURE NEEDLE | Aug 27, 1999 | Substantially Equivalent |
| K991508 | ACUMASTER BRAND ACUPUNCTURE NEEDLE | Aug 27, 1999 | Substantially Equivalent |
| K961339 | CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES | Jul 3, 1996 | Substantially Equivalent |