FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UPPER BODY CYCLES (110 VOLT)/(220 VOLT)
K Number: K935520
·
Decision Sep 16, 1994
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
159
Applicant Total
9
Review Days
302
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Basic Information
- Device Name
- UPPER BODY CYCLES (110 VOLT)/(220 VOLT)
- K Number
- K935520
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biodex Medical Systems, Inc.
- Date Received
- November 18, 1993
- Decision Date
- September 16, 1994
- Product Code
- BXB
- 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 |
|---|---|---|---|
| BXB | Exerciser, Powered | FDA class 1 | Physical Medicine |
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Other Clearances by Biodex Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090296 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 | Feb 19, 2009 | Substantially Equivalent |
| K063666 | SHARPS CONTAINER, MODEL 039-413 | Jan 25, 2007 | Substantially Equivalent |
| K951770 | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP | Nov 16, 1995 | Substantially Equivalent |
| K950981 | ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 | Apr 3, 1995 | Substantially Equivalent |
| K942694 | STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 | Mar 10, 1995 | Substantially Equivalent |
| K940301 | COMPEX 2 | Dec 28, 1994 | Substantially Equivalent for Some Indications |
| K935061 | LOWER BODY CYCLES | Sep 16, 1994 | Substantially Equivalent |
| K935216 | SEMI-RECUMBENT CYCLES | Sep 16, 1994 | Substantially Equivalent |