FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOTIVATOR FTR 2000
K Number: K942229
·
Decision Feb 27, 1995
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
60
Applicant Total
26
Review Days
297
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
- MOTIVATOR FTR 2000
- K Number
- K942229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1925
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hogan & Hartson
- Date Received
- May 6, 1994
- Decision Date
- February 27, 1995
- Product Code
- IKK
- 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 |
|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IKK), ordered by most recent decision date.
AMES THERAPY DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
HUMAC SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
FDA 510(k)
FDA Class 2
·Physical Medicine
CC RIDER, MODEL ME180
FDA 510(k)
FDA Class 2
·Physical Medicine
CYBEX 770
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXTER ISOKINETIC
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Hogan & Hartson
| K Number | Device Name | ||
|---|---|---|---|
| K974168 | COOPERSURGICAL INFRARED COAGULATOR | Jan 23, 1998 | Substantially Equivalent |
| K973849 | BIOABSORBABLE BANKART TACK | Jan 6, 1998 | Substantially Equivalent |
| K973162 | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE | Nov 20, 1997 | Substantially Equivalent |
| K950169 | RIBOSOMAL P EIA TEST SYSTEM | May 23, 1996 | Substantially Equivalent |
| K942389 | TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES | Feb 16, 1996 | Substantially Equivalent |
| K946217 | CARDIOLIPIN M EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946216 | CARDIOLIPIN A EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946215 | CARDIOLIPIN G EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946186 | CHAL-2500 | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K941566 | COMPUSPEAK | Jun 30, 1995 | Substantially Equivalent |