FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE
K Number: K830792
·
Decision Mar 29, 1983
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
8
Review Days
15
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Basic Information
- Device Name
- PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE
- K Number
- K830792
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Bomed Medical Mfr., Ltd.
- Date Received
- March 14, 1983
- Decision Date
- March 29, 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 Bomed Medical Mfr., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K853706 | BOMED-CDM | Apr 14, 1986 | Substantially Equivalent |
| K853705 | BOMED-EEA | Jan 13, 1986 | Substantially Equivalent |
| K831422 | BIOFLOW | Sep 12, 1983 | Substantially Equivalent |
| K831421 | BOMED BIOCON | Sep 12, 1983 | Substantially Equivalent |
| K813020 | BOMED-NCCOM | Dec 14, 1981 | Substantially Equivalent |
| K811999 | BO MED BIA | Aug 31, 1981 | Substantially Equivalent |
| K810064 | PULSARII, HIGH VOLT. GALVANIC MUSC. STIM | Jan 26, 1981 | Substantially Equivalent |