Who else makes this device?

Name: PAD 3020-XLT
Brand: PAD 3020-XLT

PAD 3020-XLT · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) → Cardiovascular

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

1recall

Who Else Makes It

All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DRO
Manufacturer	City	Province	Registered as	Device types
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
EMI (Dongguan) Asia Limited	Dongguan	Guangdong	Contract manufacturer	9

Record

Regulatory record for PAD 3020-XLT
Listed by	TZ Medical, Inc., United States
FDA product code	DRO
Device type	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device class	Class 2
Regulation	21 CFR 870.5550
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Record published	2023-09-20

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for PAD 3020-XLT
Catalogue number	Size	Status
PAD 3020-XLT		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
M Series Biphasic	Zoll Medical Corporation	97
Defibrillation Electrodes	TZ Medical, Inc.	31
Medi-Trace Cadence	Cardinal Health	17
Kendall	Cardinal Health	5
R Series	Zoll Medical Corporation	5
HeartStart	Philips Medical Systems Hsg	2
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Philips Medical Systems Hsg	2
Pedi-Padz	Zoll Medical Corporation	1
PAD 1115Z	TZ Medical, Inc.	1
Pad 101NHK	TZ Medical, Inc.	1
PAD 1114	TZ Medical, Inc.	1
PAD 3020-HP	TZ Medical, Inc.	1

Showing 12 of 36. All products under Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K983196	1999-09-15
K983232	1999-09-15

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2013-04-30	Class II	Process control	TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end	US: 10,410 pieces; Outside US: 100 pieces	2013-09-05

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA.

Records are records: nothing here is an offer of sale.

PAD 3020-XLT