(148 days)
Not Found
No
The device description and performance studies focus on mechanical pressure application and biocompatibility, with no mention of AI or ML technologies.
Yes
The device is intended to reduce symptoms of nausea, which is a therapeutic effect.
No
Explanation: The device description states its purpose is to "relieve symptoms of nausea" by applying pressure, not to identify, diagnose, or monitor a medical condition.
No
The device description clearly states the device is an adjustable wrist band with a hemi-spherical button, indicating it is a physical, hardware-based device.
No, the FridaMom Anti-Nausea Bands are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. This includes things like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening.
- The FridaMom Anti-Nausea Bands are a physical device applied externally to the body. They work by applying pressure to an acupressure point on the wrist. They do not analyze any biological samples.
The description clearly states the device's function is to apply pressure to an acupressure point to relieve symptoms of nausea. This is a physical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The FridaMom Anti-Nausea Bands are intended to reduce symptoms of nausea which may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
Product codes
MVV
Device Description
The FridaMom Anti-nausea Bands are adjustable wrist bands which apply pressure to the Neiguan (P6) acupressure point to relive symptoms of nausea. The bands consist of an adjustable strap with a hemi-spherical button which applies pressure to the acupressure point.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neiguan (P6) acupressure point (wrist)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-Clinical Testing Comparison: The force applied to the Neiguan (P6) acupressure point was found to be substantially equivalent between the examined devices. Pre-clinical testing was conducted on the 1st, 50th, and 99th percentile size female wrists with the force applied by the subject device. The force applied by the subject device was found to be substantially equivalent to the predicate devices for each wrist size. Biocompatibility (cytotoxicity, sensitization and irritation) of the subject device was demonstrated per ISO 10993-1, ISO 10993-5 and ISO 10993-10
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 29, 2022
FridaBaby, LLC % Angela Lassandro Medical Device Consultant I-Squared Group, LLC 111 Ohlinger Road Shoemakersville, Pennsylvania 19555
Re: K220289
Trade/Device Name: FridaMom Anti-Nausea Bands Regulatory Class: Unclassified Product Code: MVV Dated: May 31, 2022 Received: June 1, 2022
Dear Angela Lassandro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220289
Device Name FridaMom Anti-Nausea Bands
Indications for Use (Describe)
The FridaMom Anti-Nausea Bands are intended to reduce symptoms of nausea which may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary as required by 807.92(c) | ||
|---|---|---|
| Company Information: | FridaBaby, LLC | |
| 82 NE 26th St, Suite 101 | ||
| Miami, FL 33137, USA | ||
| Contact Name: | Angela F. Lassandro | |
| Medical Device Consultant | ||
| angela@isquared.group | ||
| 484.886.8165 | ||
| Date Prepared: | 29 June 2022 | |
| Device Name: | FridaMom Anti-Nausea Bands | |
| Common Name: | Acupressure device | |
| Classification: | Class: Unclassified (Pre-Amendment) | |
| Product Code: MVV | ||
| Equivalent Device: | TumEase Acupressure Bracelets (K193374, primary predicate) | |
| Acu-strap Travel and Motion Sickness Band (K041877, secondary predicate) | ||
| Device Description: | The FridaMom Anti-nausea Bands are adjustable wrist bands which apply pressure to the Neiguan (P6) acupressure point to relive symptoms of nausea. The bands consist of an adjustable strap with a hemi-spherical button which applies pressure to the acupressure point. | |
| Intended Use: | The FridaMom Anti-nausea Bands are intended to reduce symptoms of nausea which may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure). | |
| Technological | ||
| Comparison: | In comparison to the equivalent devices, the FridaMom Anti-nausea Bands: | |
| have an identical intended use applies similar pressure profiles to the Neiguan (P6) acupressure point to relieve the symptoms of nausea offers variable pressure and tightness with similar materials does not have differences in safety and efficacy associated with minor technological differences in material and dimensions Refer to the Substantial Equivalence Table below for specific differences in material and dimensional specifications. As noted above, these differences have no impact in safety and efficacy of the device. | ||
| Pre-Clinical Testing | ||
| Comparison: | The force applied to the Neiguan (P6) acupressure point was found to be substantially equivalent between the examined devices. Pre-clinical testing was conducted on the 1st, 50th, and 99th percentile size female wrists with the force applied by the | |
| subject device. The force applied by the subject device was | ||
| found to be substantially equivalent to | ||
| the predicate devices for each wrist size. | ||
| Biocompatibility (cytotoxicity, sensitization and irritation) of the | ||
| subject device was demonstrated per ISO 10993-1, ISO 10993-5 and | ||
| ISO 10993-10 | ||
| Clinical Data | ||
| Comparison: | Clinical data are not required for the determination of substantial | |
| equivalence. | ||
| Equivalent Safety and | ||
| Efficacy Conclusions: | Based on the technological and pre-clinical testing the FridaMom | |
| Anti-nausea Bands are substantially equivalent to the predicate | ||
| devices. Detailed substantial equivalence discussion is shown in | ||
| the Substantial Equivalence Table below. |
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5
510(k) Summary – K220289
Substantial Equivalence Table
| | FridaMom Anti-nausea Bands
(Subject Device) | TumEase Acupressure Bracelets
(Primary Predicate) | Acu-Strap Travel and Motion Sickness Band
(Secondary Predicate) | Substantial Equivalence
Discussion |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (Subject Device) | | (Secondary Predicate) | |
| Classification | Unclassified; Product Code MVV | Unclassified; Product Code MVV, K193374 | Unclassified; Product Code MVV, K041877 | |
| Indications | The FridaMom Anti-Nausea Bands
are intended to reduce symptoms
of nausea which may be
experienced due to
Travel/Motion,
Pregnancy/Morning Sickness,
Chemotherapy, and Anesthesia
(post-procedure). | The acupressure bracelets are intended to
reduce symptoms of nausea. Nausea may be
experienced due to Travel/Motion,
Pregnancy/Morning Sickness, Chemotherapy,
and Anesthesia (post-procedure). | The Acu-Strap TM Travel and Motion Sickness Band
is intended for the relief of nausea.
Nausea may be experienced due to Travel (Motion
Sickness), Pregnancy (Morning Sickness), Anesthesia
or Chemotherapy. | Identical with only slight
grammatical or formatting
differences which have no
impact on the safety or efficacy. |
| Band
Dimensions | Length: 240.78mm (9.48 in)
Width: 16.00 mm (0.63 in) | Length: 330.2 mm (13 in)
Width: 25.4 mm (1 in) | Not publicly available | The most significant
technological attribute of the
devices is the ability to apply
pressure to the Neiguan (P6)
pressure point which has been
shown to be substantially
equivalent. The dimensions of
the subject device were
selected to accommodate wrist
sizes from the 1st to 90th
percentile of women. The
minor differences in dimensions
do not impact the overall safety
and efficacy of the device. |
| Band
Material | Silicone | Cloth and Velcro | Cloth and Plastic | The most significant
technological attribute of the
devices is the ability to apply
pressure to the Neiguan (P6)
pressure point which has been
shown to be substantially
equivalent. Materials in both
devices are well-established |
| | | | | materials which do not pose
safety risks to the user. The
subject device has been
assessed for biocompatibility.
The minor differences in
material do not impact the
overall safety and efficacy of the
device. |
| Pressure
Point
Dimensions | Ø 10.16 mm (Ø 0.4 in) | Ø12.19 mm (Ø 0.48 in) | Not publicly available | The most significant
technological attribute of the
devices is the ability to apply
pressure to the Neiguan (P6)
pressure point which has been
shown to be substantially
equivalent. The minor
differences in dimensions do
not impact the overall safety
and efficacy of the device. |
| Pressure
Point
Material | ABS | Medical Grade Stainless Steel (316) | Not publicly available | The most significant
technological attribute of the
devices is the ability to apply
pressure to the Neiguan (P6)
pressure point which has been
shown to be substantially
equivalent. Materials in both
devices are well-established
materials which do not pose
safety risks to the user. The
subject devices has been
assessed for biocompatibility.
The minor differences in
material do not impact the
overall safety and efficacy of the
device. |
| Pressure
Point
Location | Neiguan (P6) | Neiguan (P6) | Neiguan (P6) | Identical |
| Device
Application
& Features | Variable Pressure that ranges from
0.52 lbf to 0.80 lbf
(achieved through holes used to
select size)
Non-elastic design
Used on both wrists | Adjustable:
Lbf: 0.74 @ Normal
Lbf: 0.26 @ Loose | Non-variable pressure
(one size)
Elastic design
Used on both wrists | The subject and primary
predicate devices have a strap
that allows for variable tightness
using a non-elastic design. Both
allow the user to control the
amount of pressure and
tightness of the band. The
minor differences in how the
variable tightness is achieved do
not impact the overall safety
and efficacy of the device. The
secondary predicate does not
offer variable pressure and
relies on elastic design to
accommodate wrist sizes. The
differences in how variable
pressure are achieve do not
raise issues of safety and
efficacy.
All devices are used on both
wrists simultaneously, raising no |
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510(k) Summary – K220289
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