FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE SIGNATURE SERIES, M IV
K Number: K933197
·
Decision Jun 2, 1995
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
10
Review Days
701
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Basic Information
- Device Name
- THE SIGNATURE SERIES, M IV
- K Number
- K933197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Progressive Electrical Therapeutics
- Date Received
- July 1, 1993
- Decision Date
- June 2, 1995
- 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 Progressive Electrical Therapeutics
| K Number | Device Name | ||
|---|---|---|---|
| K943972 | EURO TECH DIAMOND CHIROPRACTIC TABLE | Oct 11, 1994 | Substantially Equivalent |
| K943974 | EURO TECH MARQUISE CHIROPRACTIC TABLE | Sep 29, 1994 | Substantially Equivalent |
| K943975 | EURO TECH PLATINUM CHIROPRACTIC TABLE | Sep 29, 1994 | Substantially Equivalent |
| K943973 | EURO TECH STERLING ROLLER TABLE | Sep 29, 1994 | Substantially Equivalent |
| K933194 | THE SIGNATURE SERIES, IMC IV | Jul 13, 1994 | Substantially Equivalent |
| K933196 | THE SIGNATURE SERIES, IC II | Jul 12, 1994 | Substantially Equivalent |
| K934919 | THE SIGNATURE SERIES, MAGNUM 100 | Apr 6, 1994 | Substantially Equivalent |
| K933195 | THE SIGNATURE SERIES, IC IV | Feb 23, 1994 | Substantially Equivalent for Some Indications |
| K914394 | BACK MASTER | Nov 13, 1991 | Substantially Equivalent |