FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PAM PLUS
K Number: K913998
·
Decision Jan 8, 1992
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
64
Applicant Total
48
Review Days
124
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
- PAM PLUS
- K Number
- K913998
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kinetic Concepts, Inc.
- Date Received
- September 6, 1991
- Decision Date
- January 8, 1992
- Product Code
- IRO
- 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 |
|---|---|---|---|
| IRO | Vibrator, Therapeutic | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IRO), ordered by most recent decision date.
QI GONG MASSAGER
FDA 510(k)
FDA Class 1
·Physical Medicine
COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER
FDA 510(k)
FDA Class 1
·Physical Medicine
MASSAGER THERAPUTIC, ELECTRIC
FDA 510(k)
FDA Class 1
·Physical Medicine
SHIATSU MASTER MASSAGER CUSHION
FDA 510(k)
FDA Class 1
·Physical Medicine
CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
CONAIR FAMILY FITNESS BODY ENERGY
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Kinetic Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050261 | V.A.C. GRANUFOAM SILVER PROTECTION DRESSING | May 26, 2005 | Substantially Equivalent |
| K041642 | V.A.C. GRANUFOAM SILVER DRESSING | Jan 25, 2005 | Substantially Equivalent |
| K032310 | MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS | Oct 10, 2003 | Substantially Equivalent |
| K022011 | V.A.C. ABDOMINAL DRESSING | Feb 26, 2003 | Substantially Equivalent |
| K021500 | VACUUM ASSISTED CLOSURE | Dec 20, 2002 | Substantially Equivalent |
| K021501 | V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT | Dec 2, 2002 | Substantially Equivalent |
| K020781 | WET CHAMBER | May 6, 2002 | Substantially Equivalent |
| K992448 | V.A.C. PLUS | Jan 18, 2000 | Substantially Equivalent |
| K972176 | HOME CARE BEAD BED | Jan 16, 1998 | Substantially Equivalent |
| K972549 | SIMPULSE | Nov 18, 1997 | Substantially Equivalent |