510(k) K202993
- Device
- 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
- 510(k) number
- K202993
- Product code
- PHW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-15
- Date received
- 2020-09-30
- Regulation
- 890.5975
- Classification name
- Cold Pack And Vibrating Massager
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Amy Baxter
- Address
- 195 Arizona Ave. Lw08 Atlanta GA US 30307 30307
FDA Registration Numbers#
- 3043153468
- 3008469990
- 3021282523
- 3043126945
- 3015619973
- 3008500974
- 3016452327
- 3016446653
- 3043709758
- 3007439125
- 3015220641
- 3014422258
- 3016147813
- 3011118556
- 3017555752
- 3016879560
- 3030488262
- 3038319732
- 3005740303
- 3043140693
- 3014561131
- 1832894
Source Documents#
Other 510(k) Records For Product Code PHW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130631 | BUZZY | Mmj Labs, LLC | 2014-08-13 |