FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
'TENSAID'
K Number: K863567
·
Decision Oct 24, 1986
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
8
Review Days
42
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
- 'TENSAID'
- K Number
- K863567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Electro Therapeutic Devices, Inc.
- Date Received
- September 12, 1986
- Decision Date
- October 24, 1986
- 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 Electro Therapeutic Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981272 | ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES | Aug 24, 1998 | Substantially Equivalent |
| K875317 | ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID | Sep 8, 1989 | Substantially Equivalent |
| K863568 | 'MYOSTIM EX' | Oct 24, 1986 | Substantially Equivalent |
| K853718 | TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 | Dec 4, 1985 | Substantially Equivalent |
| K853719 | TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410 | Dec 4, 1985 | Substantially Equivalent |
| K843119 | ETI TENS BELT | Aug 17, 1984 | Substantially Equivalent |
| K770686 | THERATHERM | Jul 14, 1977 | Substantially Equivalent |