PNEUMATIC DORSIFLEXOR
FDA 510(k) clearance K890200 · decided 1989-02-03
Clearance details
- K-number
- K890200
- Device name
- PNEUMATIC DORSIFLEXOR
- Applicant
- Medical Flotation Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-18
- Decision date
- 1989-02-03
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- BXB
- Device class
- 1
- Regulation number
- 890.5380
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Herndon, VA, US
- 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 |
|---|---|---|
| G-TRAINER MEDICAL (K072887) | Alter-G, Inc. | 2008-01-25 |
| FLO-BOOT (K003272) | Discovery Group, LLC | 2001-04-04 |
| ANKLE CALF EXERCISER PHLEBOPUMP (K952975) | Prevent Products, Inc. | 1996-09-25 |
| E-Z FLEX (K953456) | Fluid Motion Biotechnologies, Inc. | 1996-01-26 |
| BTE CPM-20 (K955106) | Baltimore Therapeutic Equipment Co. | 1995-12-29 |
| BTE CPM-10 (K955105) | Baltimore Therapeutic Equipment Co. | 1995-12-29 |
| HAMEX TWO (K951028) | Northern Orthopaedic Products, Inc. | 1995-12-11 |
| FLEXMATE K500 (K950755) | Breg, Inc. | 1995-10-05 |
| HAMEX ONE (K951029) | Northern Orthopaedic Products, Inc. | 1995-09-15 |
| AQUAHAB, MODEL 120-72-101 (K945733) | Aquarius Electronics, Inc. | 1995-09-15 |
| W2 WRIST CPM UNIT (K950682) | Toronto Medical Corp. | 1995-09-13 |
| KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE (K952369) | Physicians Consulting, Inc. | 1995-08-07 |
Recalls involving this device
No recalls on record reference this clearance.