FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-TENS
K Number: K844618
·
Decision Aug 21, 1985
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
10
Review Days
267
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
- BIO-TENS
- K Number
- K844618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Research Associates, Inc.
- Date Received
- November 27, 1984
- Decision Date
- August 21, 1985
- 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 Bio-Research Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K130158 | M-SCAN | Jul 25, 2013 | Substantially Equivalent |
| K082927 | BIOEMG III | Feb 6, 2009 | Substantially Equivalent |
| K061799 | QUADRATENS, MODEL QT-42 | Aug 28, 2006 | Substantially Equivalent |
| K003176 | BIOEMG II AND BIOJVA | Jan 4, 2001 | Substantially Equivalent |
| K991756 | 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE | Dec 10, 1999 | Substantially Equivalent |
| K981563 | BIOPAK MEASUREMENT SYSTEM | Sep 15, 1998 | Substantially Equivalent |
| K952218 | JT-3 ELECTROGNATHOGRAPH | Sep 21, 1995 | Substantially Equivalent |
| K873947 | BIO-EMG MODEL 800 | Apr 27, 1988 | Substantially Equivalent |
| K822565 | NEEDLE CATHETER JEJUNOSTOMY KIT | Sep 28, 1982 | Substantially Equivalent |