FPL
FDA 510(k) clearance K915897 · decided 1992-04-07
Clearance details
- K-number
- K915897
- Device name
- FPL
- Applicant
- Wrm Computers
- Decision
- Substantially Equivalent
- Date received
- 1991-11-25
- Decision date
- 1992-04-07
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- IKE
- Device class
- 1
- Regulation number
- 890.1615
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Holland, HN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SONIC PALPOMETER (K060125) | Palpometer Systems, Inc. | 2006-03-16 |
| PRESSORE MONITOR (K954670) | Cleveland Medical Devices, Inc. | 1995-10-30 |
| THE EQUALIZER (K915369) | Advanced Rehabilitative Technology, Inc. | 1993-03-22 |
| PORTABLE LIMB LOAD MONITOR (BMLLM-100) (K915326) | Bar Med Pty , Ltd. | 1992-10-20 |
| IOWA ORAL PERFORMANCE ISNTRUMENT (K920091) | Breakthrough, Inc. | 1992-05-20 |
| TALLEY SD.500 SKIN PRESSURE EVALUATOR (K914780) | Talley Group, Ltd. | 1991-12-19 |
| MICRO-EMED-SYSTEM (K902967) | Novel Electronics, Inc. | 1990-09-17 |
| DYNATRON 2000 (K880912) | Dynatronics Corp. | 1988-03-15 |
| BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 (K875103) | Shield Computers , Ltd. | 1988-01-20 |
| EMED-F-SYSTEM (K871690) | Novel GmbH | 1987-05-15 |
| PODOSCOPE (K864499) | Broadwest Corp. | 1987-02-04 |
| PODODIGITAL (K864569) | Broadwest Corp. | 1987-02-04 |
Recalls involving this device
No recalls on record reference this clearance.