FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BX-600 EMS
K Number: K832976
·
Decision Nov 25, 1983
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
16
Review Days
84
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Basic Information
- Device Name
- BX-600 EMS
- K Number
- K832976
- 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
- September 2, 1983
- Decision Date
- November 25, 1983
- 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 |
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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 |
| 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 |
| K811114 | MODEL P-8 PROFESSIONAL | Nov 23, 1981 | Substantially Equivalent |