Pulsed electromagnetic field wrap
FDA 510(k) clearance K202337 · decided 2020-12-15
Clearance details
- K-number
- K202337
- Device name
- Pulsed electromagnetic field wrap
- Applicant
- Hi-Dow International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-08-17
- Decision date
- 2020-12-15
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- ILX
- Device class
- 2
- Regulation number
- 890.5290
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Maryland Heights, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.