FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO THERAPY PLUS
K Number: K922205
·
Decision Aug 11, 1992
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
19
Review Days
91
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Basic Information
- Device Name
- BIO THERAPY PLUS
- K Number
- K922205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sunrise Medical, Inc.
- Date Received
- May 12, 1992
- Decision Date
- August 11, 1992
- Product Code
- FNM
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | FDA class 2 | General Hospital |
Similar 510(k) Clearances
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SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
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|---|---|---|---|
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| K983677 | QUICKIE G SERIES, MODEL G-424 | Nov 6, 1998 | Substantially Equivalent |
| K983520 | BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD | Nov 6, 1998 | Substantially Equivalent |
| K981462 | QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300 | Nov 6, 1998 | Substantially Equivalent |