NormaTec Pulse and NormaTec Pulse Pro
FDA 510(k) clearance K160608 · decided 2016-04-13
Clearance details
- K-number
- K160608
- Device name
- NormaTec Pulse and NormaTec Pulse Pro
- Applicant
- NormaTec Industries, LP
- Decision
- Substantially Equivalent
- Date received
- 2016-03-03
- Decision date
- 2016-04-13
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Newton, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.