FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NERVE STIMULATOR, ELEC. TRANSCUTANEOUS
K Number: K772224
·
Decision Dec 15, 1977
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
6
Review Days
10
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
- NERVE STIMULATOR, ELEC. TRANSCUTANEOUS
- K Number
- K772224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Stimulation Technology, Inc.
- Date Received
- December 5, 1977
- Decision Date
- December 15, 1977
- 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 Stimulation Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K791048 | STIMTECH NEUROMUSCULAR STIMULATOR, C 600 | Jul 3, 1979 | Substantially Equivalent |
| K790345 | STIMTECH TENS ELECTRODE | Mar 21, 1979 | Substantially Equivalent |
| K781565 | ELECTRICAL NERVE STIMULATOR MODEL 6035 | Oct 11, 1978 | Substantially Equivalent |
| K770448 | INS - T.E.N.S. | Mar 15, 1977 | Substantially Equivalent |
| K770447 | EPC INSTICKS | Mar 15, 1977 | Substantially Equivalent |