510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Slow Wave, Inc.

Lakeway, TX, US

Slow Wave, Inc. appears in FDA device records in Lakeway, TX. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Slow Wave, Inc. between 2020 and 2024. The busiest year on record is 2020, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Slow Wave, Inc., by decision year
YearClearances
20201
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K240463Slow Wave DS8 (SWDS802)MQCSubstantially Equivalent
K191320Slow Wave DS8LQZSubstantially Equivalent

Registered establishments

FDA registered establishments for Slow Wave, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30175203373017520337Slow Wave, Inc.1150 Lakeway Dr Ste 213, Lakeway, TX 78734 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain