FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE
K Number: K831850
·
Decision Jul 19, 1983
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
8
Review Days
40
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Basic Information
- Device Name
- NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE
- K Number
- K831850
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Th Charters, Inc.
- Date Received
- June 9, 1983
- Decision Date
- July 19, 1983
- 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 |
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Other Clearances by Th Charters, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873357 | ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA. | Oct 26, 1987 | Substantially Equivalent |
| K861501 | EXER-STIM 2 | May 8, 1986 | Substantially Equivalent |
| K851967 | TORQUE FEEDBACK METER | Jul 19, 1985 | Substantially Equivalent |
| K851946 | REMOTE SPEED CONTROL | Jul 19, 1985 | Substantially Equivalent |
| K834215 | MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM | Jan 3, 1984 | Substantially Equivalent |
| K822056 | EXER-STIM CONTROLLER | Oct 6, 1982 | Substantially Equivalent |
| K800486 | STIM-EX 201 | Mar 19, 1980 | Substantially Equivalent |