Product code MVK
- Device name
- Wearable Automated External Defibrillator
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The device is an automatic external defibrillator which monitors and treats a patient for ventricular defibrillation. Device is intended to be worn in home or in hospital settings as prescribed and overseen by a physician.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P010030S200 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | 2026-05-15 |
| P200037S019 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | 2026-04-14 |
| P200037S018 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | 2026-03-06 |
| P230022S003 | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class | Element Science, Inc. | 2026-03-04 |
| P010030S199 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | 2026-01-29 |
| P230022S006 | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati | Element Science, Inc. | 2026-01-13 |
| P010030S198 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | 2025-12-11 |
| P010030S197 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | 2025-12-09 |
| P230022S004 | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati | Element Science, Inc. | 2025-11-19 |
| P230022S002 | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class | Element Science, Inc. | 2025-11-18 |
| P230022S001 | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati | Element Science, Inc. | 2025-08-20 |
| P010030S196 | LifeVest® Wearable Defibrillator, Model 4000 | Zoll Manufacturing Corporation | 2025-08-13 |
| P200037S017 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | 2025-07-22 |
| P010030S195 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | 2025-07-16 |
| P010030S194 | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST | Zoll Manufacturing Corporation | 2025-07-16 |
| P010030S193 | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST | Zoll Manufacturing Corporation | 2025-05-30 |
| P010030S191 | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST | Zoll Manufacturing Corporation | 2025-05-30 |
| P010030S192 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | 2025-05-13 |
| P230022 | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati | Element Science, Inc. | 2025-04-30 |
| P200037S016 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | 2025-04-25 |
| P010030S190 | LifeVest Wearable Defibrillator | Zoll Manufacturing Corporation | 2025-01-07 |
| P010030S189 | LifeVest Wearable Defibrillator | Zoll Manufacturing Corporation | 2024-12-16 |
| P010030S188 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | 2024-11-24 |
| P010030S187 | LifeVest Wearable Defibrillator | Zoll Manufacturing Corporation | 2024-10-18 |
| P200037S014 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | 2024-10-08 |
| P010030S182 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | 2024-09-18 |
| P200037S013 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | 2024-09-03 |
| P010030S186 | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST | Zoll Manufacturing Corporation | 2024-08-28 |
| P010030S185 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | 2024-08-27 |
| P010030S184 | LifeVest Wearable Defibrillator, Model 5100 | Zoll Manufacturing Corporation | 2024-07-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850047782052 | Jewel Mobile App | Element Science, Inc. | 2026-05-04 |
| 00850047782168 | Jewel Mobile App | Element Science, Inc. | 2026-05-04 |
| 00840241600375 | ASSURE WCD System | Kestra Medical Technologies, Inc. | 2026-04-15 |
| 00840241600405 | ASSURE, Monitor | Kestra Medical Technologies, Inc. | 2026-04-15 |
| 00850047782007 | "Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (""Jewel"")" | Element Science, Inc. | 2025-05-12 |
| 00850047782038 | Jewel Starter Kit | Element Science, Inc. | 2025-05-12 |
| 00850047782090 | Jewel Patch | Element Science, Inc. | 2025-05-12 |
| 00855778005432 | LifeVest Wearable Defibrillator | ZOLL MANUFACTURING CORPORATION | 2024-08-21 |
| 00855778005449 | LifeVest Wearable Defibrillator | ZOLL MANUFACTURING CORPORATION | 2024-08-21 |
| 00855778005401 | LifeVest Wearable Defibrillator | ZOLL MANUFACTURING CORPORATION | 2024-08-19 |
| 00855778005371 | LifeVest Wearable Defibrillator | ZOLL MANUFACTURING CORPORATION | 2024-08-19 |
| 00855778005388 | LifeVest Wearable Defibrillator | ZOLL MANUFACTURING CORPORATION | 2024-08-19 |
| 00855778005395 | LifeVest Wearable Defibrillator | ZOLL MANUFACTURING CORPORATION | 2024-08-19 |
| 00840241600238 | ASSURE WCD System | Kestra Medical Technologies, Inc. | 2023-06-26 |
| 00840241600245 | ASSURE, Tablet | Kestra Medical Technologies, Inc. | 2022-12-09 |
| 00840241600221 | ASSURE, Monitor | Kestra Medical Technologies, Inc. | 2022-12-09 |
| 00840241600009 | ASSURE, Battery | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600016 | ASSURE, Charger | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600023 | ASSURE, Therapy Cable | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600030 | ASSURE, Monitor | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600047 | ASSURE WCD System | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600054 | ASSURE, Garment, Style A, Size 1 | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600061 | ASSURE, Garment, Style A, Size 2 | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600078 | ASSURE, Garment, Style A, Size 3 | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600085 | ASSURE, Garment, Style A, Size 4 | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600092 | ASSURE, Garment, Style A, Size 5 | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600108 | ASSURE, Garment, Style A, Size 6 | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600115 | ASSURE, Garment, Style A, Size 7 | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00840241600122 | ASSURE, Garment, Style B, Size 1 | Kestra Medical Technologies, Inc. | 2021-11-15 |
| 00855778005272 | Hospital Wearable Defibrillator | ZOLL MANUFACTURING CORPORATION | 2017-06-13 |