FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLENDERTONE
K Number: K790120
·
Decision May 7, 1979
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
16
Review Days
104
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
- SLENDERTONE
- K Number
- K790120
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Bloomex International, Inc.
- Date Received
- January 23, 1979
- Decision Date
- May 7, 1979
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IPF), ordered by most recent decision date.
Apollo Quattro (APQ-10M)
FDA 510(k)
FDA Class 2
·Physical Medicine
High Tone Power therapy (HiToP) (Model: HiToP PNP)
FDA 510(k)
FDA Class 2
·Physical Medicine
StimelMD (SSMD) system
FDA 510(k)
FDA Class 2
·Physical Medicine
Compact II
FDA 510(k)
FDA Class 2
·Physical Medicine
EVE Synergy (EVE-20M)
FDA 510(k)
FDA Class 2
·Physical Medicine
TrainFES Advance
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Bloomex International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943185 | BX-200 SC | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K942195 | BX-400S | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K842142 | BX-400 | Jun 25, 1984 | Substantially Equivalent |
| K841779 | ELECTRONIC MUSCLE EXERCISE EQUIPMENT | May 30, 1984 | Substantially Equivalent |
| K832976 | BX-600 EMS | Nov 25, 1983 | Substantially Equivalent |
| K822287 | BX-500 ELECTRONIC MUSCLE EXERCISER | Oct 13, 1982 | Substantially Equivalent |
| K821110 | ELECTRONIC MUSCLE EXERCISER | Jul 1, 1982 | Substantially Equivalent |
| K820080 | BX-1000 ISOMATIC | Jul 1, 1982 | Substantially Equivalent |
| K813410 | BX-400 JESSE JIMBODY | Mar 8, 1982 | Substantially Equivalent |
| K813443 | BX-400 SPORT | Mar 8, 1982 | Substantially Equivalent |