FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHODERM THERAPY BED
K Number: K874801
·
Decision Feb 5, 1988
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
13
Review Days
74
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Basic Information
- Device Name
- ORTHODERM THERAPY BED
- K Number
- K874801
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Health Products, Inc.
- Date Received
- November 23, 1987
- Decision Date
- February 5, 1988
- 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
Other 510(k) clearances with the same product code (FNM), ordered by most recent decision date.
PRESSURE GUARD SITE SELECT (A)
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MIGHTY AIR
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PHYSIO/1000
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SIMPULSE
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SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
FDA 510(k)
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Other Clearances by Health Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912866 | PEAK EXPIRATORY FLOW METER | Aug 13, 1992 | Substantially Equivalent |
| K912943 | THRESHOLD 2X INSPIRATORY MUSCLE TRAINER | Jan 30, 1992 | Substantially Equivalent |
| K911807 | METERED DOSE INHALER (MDI) SPACER | Oct 23, 1991 | Substantially Equivalent |
| K902292 | MODIFIED ASSESS(R) PEAK FLOW METER | Aug 10, 1990 | Substantially Equivalent |
| K896953 | MODIFIED ASSESS(R) PEAK FLOW METER | Jan 30, 1990 | Substantially Equivalent |
| K894353 | ORTHODERM CONVERTIBLE | Aug 9, 1989 | Substantially Equivalent |
| K890426 | CONSUMMATE AIR THERAPY BED | Apr 5, 1989 | Substantially Equivalent |
| K871742 | MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER | Jun 15, 1987 | Substantially Equivalent |
| K870514 | THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER | Mar 31, 1987 | Substantially Equivalent |
| K864719 | PFLEX EM(TM) (EXERCISE MONITOR) | Mar 16, 1987 | Substantially Equivalent |