FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OBSTETRIC PULSAR TWO CHANNEL TENS
K Number: K840497
·
Decision Apr 16, 1984
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
17
Review Days
70
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
- OBSTETRIC PULSAR TWO CHANNEL TENS
- K Number
- K840497
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Spembly Medical , Ltd.
- Date Received
- February 6, 1984
- Decision Date
- April 16, 1984
- 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 Spembly Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K925129 | SELECTOR | Apr 23, 1993 | Substantially Equivalent |
| K903303 | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | Oct 11, 1990 | Substantially Equivalent |
| K901974 | SELECTOR ULTRASONIC SURGICAL ASPIRATOR | Sep 5, 1990 | Substantially Equivalent |
| K882568 | 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY | Sep 27, 1988 | Substantially Equivalent |
| K882962 | SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) | Aug 8, 1988 | Substantially Equivalent |
| K882963 | SPEMBLY MEDICAL 142 CRYO UNIT | Aug 8, 1988 | Substantially Equivalent |
| K874367 | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | Jan 4, 1988 | Substantially Equivalent |
| K832385 | CRYOPROBES MC-1400-CRYOSURG-CONSOLE | Sep 12, 1983 | Substantially Equivalent |
| K832334 | CRYOMEDICS 5000 CRYOSURGICAL CONSOLE | Aug 12, 1983 | Substantially Equivalent |
| K832140 | CRYOMEDICS 5000 CRYOPROBES | Aug 12, 1983 | Substantially Equivalent |