CHOYANG THERMAL MASSAGER
FDA 510(k) clearance K111941 · decided 2012-05-25
Clearance details
- K-number
- K111941
- Device name
- CHOYANG THERMAL MASSAGER
- Applicant
- Choyang Medical Instrument Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-08
- Decision date
- 2012-05-25
- Days to decision
- 322 days
- Clearance type
- Traditional
- Product code
- JFB
- Device class
- 2
- Regulation number
- 890.5880
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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| N5-1 (K153054) | Nuga Medical Co., Ltd. | 2016-02-05 |
| CERAGEM AUTOMATIC THERMAL MASSAGER (K140592) | Ceragem International, Inc. | 2014-12-17 |
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Recalls involving this device
No recalls on record reference this clearance.