FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONITOR, MYO, MODEL J3
K Number: K770252
·
Decision Feb 18, 1977
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
8
Review Days
9
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
- MONITOR, MYO, MODEL J3
- K Number
- K770252
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Myo-Tronics Research, Inc.
- Date Received
- February 9, 1977
- Decision Date
- February 18, 1977
- Product Code
- NUW
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| NUW | Stimulator, Muscle, Powered, Dental | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NUW), ordered by most recent decision date.
BTL-785MJ
FDA 510(k)
FDA Class 2
·Physical Medicine
D function
FDA 510(k)
FDA Class 2
·Physical Medicine
MYO-TRODE SG DISPOSABLE ELECTRODE
FDA 510(k)
FDA Class 2
·Physical Medicine
MODEL J-5 MVO-MONITOR
FDA 510(k)
FDA Class 2
·Physical Medicine
ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE
FDA 510(k)
FDA Class 2
·Physical Medicine
ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Myo-Tronics Research, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K842223 | J4 MYO-MONITOR | Nov 19, 1984 | Substantially Equivalent |
| K842224 | BNS 40 | Nov 19, 1984 | Substantially Equivalent |
| K833132 | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | Feb 10, 1984 | Substantially Equivalent |
| K831364 | TESTCORP RA | May 27, 1983 | Substantially Equivalent |
| K830034 | MODEL EM-2 BIOELECTRIC PROCESSOR | Feb 9, 1983 | Substantially Equivalent |
| K813533 | ELECTRIC MUSCLE STIMULATOR | Mar 5, 1982 | Substantially Equivalent |
| K810528 | MODEL EM-IR | Mar 31, 1981 | Substantially Equivalent |