Who else makes this device?

Name: PAD 3010-QC
Brand: PAD 3010-QC

PAD 3010-QC · 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 3010-QC
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
510(k)	K983196
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 3010-QC
Catalogue number	Size	Status
PAD 3010-QC		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
PAD 3020-XLT	TZ Medical, Inc.	1
Pedi-Padz	Zoll Medical Corporation	1
PAD 1115Z	TZ Medical, Inc.	1
Pad 101NHK	TZ Medical, Inc.	1
PAD 1114	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 Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of PAD 3010-QC
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
TZ Medical, Inc.	510(k) number	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 3010-QC