BRACE, TENNIS ELBOW
FDA 510(k) clearance K780053 · decided 1978-01-17
Clearance details
- K-number
- K780053
- Device name
- BRACE, TENNIS ELBOW
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1978-01-09
- Decision date
- 1978-01-17
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- IQI
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Walker, MI, 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 |
|---|---|---|
| Neurosplint (K143458) | Neurospectrum, LLC | 2015-08-13 |
| SENSOR WALK (K052771) | Otto Bock Healthcare LP | 2006-05-03 |
| SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (K031576) | Surgitech, Inc. | 2003-07-31 |
| ACCUFLEX DYNAMIC ELBOW ORTHOSIS (K926391) | Regulatory & Marketing Services, Inc. | 1993-07-22 |
| MCCONNELL SHOULDER BRACE (K910974) | Mcconnell Orthopedic | 1991-03-21 |
| GAIT-AID ORTHOPEDIC INSOLE (K874502) | Gait-Aid, Inc. | 1987-11-30 |
| ADJUSTABLE POLYCENTRIC ELBOW HINGE (K831542) | Fred Sammons, Inc. | 1983-06-24 |
| DROP FOOT BRACE (K831615) | Edward Dilauro, Jr. | 1983-06-15 |
| VARIOUS SUPPORTS AND SPLINTS (K823812) | Danek Medical, Inc. | 1983-01-14 |
| BRACE-UP ALL PURPOSE WRIST BAND (K823113) | Arco Matic, Inc. | 1982-11-16 |
| ROTATION BOOT (K823160) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| BRACE-UP STOCKING KNEE BRACE (K823114) | Arco Matic, Inc. | 1982-11-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |