WRIGHT GRADIENT 52 - TORSO
FDA 510(k) clearance K131387 · decided 2013-11-20
Clearance details
- K-number
- K131387
- Device name
- WRIGHT GRADIENT 52 - TORSO
- Applicant
- Wright Therapy Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-14
- Decision date
- 2013-11-20
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Oakdale, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.