FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST
K Number: K915092
·
Decision Feb 11, 1992
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
152
Applicant Total
5
Review Days
82
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Basic Information
- Device Name
- TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST
- K Number
- K915092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5650
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Progressive Medical Technology, Inc.
- Date Received
- November 21, 1991
- Decision Date
- February 11, 1992
- Product Code
- IRP
- 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 |
|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | FDA class 2 | Physical Medicine |
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Other Clearances by Progressive Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923710 | OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED | Mar 22, 1993 | Substantially Equivalent |
| K915638 | TALLEY TM200 INTERMTTENT COMPRESSION UNIT | Feb 11, 1992 | Substantially Equivalent |
| K915637 | TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST. | Feb 11, 1992 | Substantially Equivalent |
| K915671 | B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT | Jan 13, 1992 | Substantially Equivalent |