FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIR
K Number: K864918
·
Decision Dec 24, 1986
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
52
Applicant Total
13
Review Days
8
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Basic Information
- Device Name
- HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIR
- K Number
- K864918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3110
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Health Products, Inc.
- Date Received
- December 16, 1986
- Decision Date
- December 24, 1986
- Product Code
- INO
- 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 |
|---|---|---|---|
| INO | Chair, Positioning, Electric | FDA class 2 | Physical Medicine |
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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 |
| K874801 | ORTHODERM THERAPY BED | Feb 5, 1988 | 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 |