FDA product code MVV: Device, Acupressure
MVV is the FDA product code for device, acupressure. It is a Unclassified device, reviewed by the Neurology panel. FDA has cleared 13 510(k) submissions under MVV, 1 in the last five years, from 13 different applicants. The average 510(k) review took 124 days (median 90). FDA has posted 1 recall for MVV devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Acupressure |
| Device class | Unclassified |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
510(k) clearances per year for MVV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 90 |
| 2021 | 1 | 79 |
| 2022 | 1 | 148 |
Compare with all 510(k) review times · Search every MVV clearance
Top MVV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fridababy, LLC | 1 | 2022-06-29 |
| Wellspring Pharmaceutical Corporation | 1 | 2021-09-01 |
| Mumease | 1 | 2020-03-04 |
| Pressure Point, Inc. | 1 | 2014-12-01 |
| Doodlebug Products, LLC | 1 | 2012-02-27 |
8 more applicants have MVV clearances. See the full list in Caduvo.
Most recent MVV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220289 | Fridababy, LLC | FridaMom Anti-Nausea Bands | 2022-06-29 | 148 |
| K211823 | Wellspring Pharmaceutical Corporation | Bonine Acupressure Bands | 2021-09-01 | 79 |
| K193374 | Mumease | TumEase Acupressure Bracelets | 2020-03-04 | 90 |
| K142471 | Pressure Point, Inc. | Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip | 2014-12-01 | 89 |
| K110821 | Doodlebug Products, LLC | BARF BAND | 2012-02-27 | 340 |
Recalls for MVV devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-04-26.
Frequently asked questions
What is FDA product code MVV?
MVV is the FDA product code for device, acupressure. It is a Unclassified device, reviewed by the Neurology panel.
What device class is MVV?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MVV?
Across 13 cleared submissions the average was 124 days from receipt to decision (median 90).
Which companies have the most MVV clearances?
Fridababy, LLC (1); Wellspring Pharmaceutical Corporation (1); Mumease (1); Pressure Point, Inc. (1); Doodlebug Products, LLC (1).
Have MVV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-04-26.
Next steps
- Run an FDA pathway report with predicate devices for product code MVV
- Run a recall and safety report across every MVV manufacturer
- Watch product code MVV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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