FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENTRY FLEXIBLE TENS
K Number: K853552
·
Decision Sep 26, 1985
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
13
Review Days
31
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
- SENTRY FLEXIBLE TENS
- K Number
- K853552
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Sentry Medical Products, Inc.
- Date Received
- August 26, 1985
- Decision Date
- September 26, 1985
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXY), ordered by most recent decision date.
BioWave BioWraps
FDA 510(k)
FDA Class 2
·Neurology
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
FDA 510(k)
FDA Class 2
·Neurology
MR Conditional Cup Electrodes
FDA 510(k)
FDA Class 2
·Neurology
Tutamen Self Adhesive Electrodes
FDA 510(k)
FDA Class 2
·Neurology
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
FDA 510(k)
FDA Class 2
·Neurology
Ceribell Brain Monitor Headband
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Sentry Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962122 | SENTRY RADIOTRANSLUCENT ECG ELECTRODES | Jul 24, 1996 | Substantially Equivalent |
| K955636 | SENTRY DISPOSABLE DISPERSIVE ELECTRODE | Mar 27, 1996 | Substantially Equivalent |
| K942827 | SENTRY INSERTION TRAY | Nov 2, 1994 | Substantially Equivalent |
| K934000 | SENTRY AQUEOUS GEL ECG ELECTRODES | Aug 30, 1994 | Substantially Equivalent |
| K935098 | BABY BOARD | Feb 15, 1994 | Substantially Equivalent |
| K933603 | LEADWIRE | Jan 18, 1994 | Substantially Equivalent |
| K932704 | PATIENT CABLE | Dec 27, 1993 | Substantially Equivalent |
| K881670 | ACCUTEMP PLUS | Nov 22, 1988 | Substantially Equivalent |
| K881343 | DURADERM BUTTERFLY | May 4, 1988 | Substantially Equivalent |
| K851522 | DIAGNOSTIC ECG DISPOSABLE ELECTRODE | Oct 24, 1985 | Substantially Equivalent |