FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
K Number: K870514
·
Decision Mar 31, 1987
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
13
Review Days
54
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
- K Number
- K870514
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Health Products, Inc.
- Date Received
- February 5, 1987
- Decision Date
- March 31, 1987
- Product Code
- BWF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BWF), ordered by most recent decision date.
InSee
FDA 510(k)
FDA Class 2
·Anesthesiology
AllPEP
FDA 510(k)
FDA Class 2
·Anesthesiology
LungTrainer (MD2 & MD3)
FDA 510(k)
FDA Class 2
·Anesthesiology
Breathe+
FDA 510(k)
FDA Class 2
·Anesthesiology
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
FDA 510(k)
FDA Class 2
·Anesthesiology
Pulsehaler
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| K864719 | PFLEX EM(TM) (EXERCISE MONITOR) | Mar 16, 1987 | Substantially Equivalent |