Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)
FDA 510(k) clearance K202993 · decided 2023-05-15
Clearance details
- K-number
- K202993
- Device name
- Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)
- Applicant
- Mmj Labs, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-09-30
- Decision date
- 2023-05-15
- Days to decision
- 957 days
- Clearance type
- Traditional
- Product code
- PHW
- Device class
- 1
- Regulation number
- 890.5975
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Atlanta, GA, 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 |
|---|---|---|
| BUZZY (K130631) | Mmj Labs, LLC | 2014-08-13 |
Recalls involving this device
No recalls on record reference this clearance.